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Treatment Options


Introduction

Breast and Cervical Cancer Prevention and Treatment Act of 2000

The Breast and Cervical Cancer Prevention and Treatment Act of 2000 gives states the option to provide treatment through Medicaid to eligible women who were screened for and found to have breast or cervical cancer, including precancerous conditions, through the National Breast and Cervical Cancer Early Detection Program (NBCCEDP). All 50 states and the District of Columbia have approved this Medicaid option.1

For Californians diagnosed with breast cancer, free treatment is available to all who qualify through the Breast and Cervical Cancer Treatment Program. Information on this program is available on Medi-Cal's website or by calling 1-800-824-0088 to speak with an eligibility specialist.

Five main types of therapies are available for the treatment of breast cancer: surgery, radiation therapy, chemotherapy, hormone therapy, and targeted therapy. Complementary therapies are also available to help patients manage symptoms and side effects with treatments (See Complementary Therapies).

Most patients are treated with surgery as the main therapy in combination with one or more additional therapies for optimal cancer management. Some of these therapies may occur prior to the main treatment. These are called neoadjuvant therapies. A woman may, for instance, receive neoadjuvant chemotherapy in order to shrink a tumor to make it operable. Other therapies are considered adjuvant therapies. Adjuvant therapy is given after the main therapy to increase the chance of long-term survival.2 Individual approaches vary based on the type, size, and location of the cancer; the stage of the cancer; and the characteristics of the cancer cells. A woman's characteristics, including age, menopausal status, and overall health are also key considerations. Finally, appropriate treatment will take into account the personal preferences of a patient who has been fully informed of all her options.

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Surgery

A Woman’s Guide to Breast Cancer Treatment: Senate Bill 1851/ Health and Safety Code Section 109275

A Woman’s Guide to Breast Cancer Treatment, developed by the California Department of Public Health, Cancer Detection Section, is a valuable guide intended to help a woman become an informed partner in making choices with her health care team.

In March 2006, the state of California passed a law requiring physicians to provide this booklet to patients diagnosed with cancer. The guide can be dowloaded or ordered in English, Chinese, Japanese, Korean, Russian, Spanish, Tagalog, and Vietnamese through the Medical Board of California.

The main treatment for breast cancer is surgery to remove the cancer. The type of surgical procedure depends upon a number of factors, including the size and location of the tumor, the type and stage of the breast cancer, the size of the breast, and a woman's personal preference. In most cases, the choice is between breast conserving surgery and mastectomy. For patients with invasive breast cancer, surgery is usually paired with an axillary lymph node or sentinel lymph node dissection for pathological staging and to help guide additional treatment decisions.

Breast Conserving Surgery

Breast conserving surgery (BCS) removes the cancer and a surrounding margin of normal breast tissue, while saving most of the breast. Lumpectomy is the most common term used for this procedure; however, it may also be called partial or segmental mastectomy, wide local excision, tylectomy, or quadrantectomy.3

The goal for all breast conserving procedures is to remove the entire breast cancer with a margin that is free of tumor invasion while saving as much of the breast as possible. If the margin shows evidence of cancer, a second surgery is required. This will usually be a repeat lumpectomy (also called a re-excision), or in some cases, a mastectomy. 

For patients with invasive breast cancer, BCS is almost always followed with radiation therapy. Small metallic clips may be placed inside the breast during surgery to mark the area for radiation.3

Women ages 70 and older may be able to forego radiation therapy after BCS under certain circumstances: 4  

  • The tumor was smaller than 2 cm and was completely removed.
  • The tumor was hormone-receptor positive.
  • No cancer was found in the lymph nodes.
  • The patient received hormone therapy.

Criteria precluding breast conserving surgery:

  • a history of radiotherapy to the breast or chest
  • signs of cancer throughout the breast
  • multiple tumors that cannot be removed with one cut into the breast
  • inability to remove all of the cancer while keeping an acceptable look of the breast
  • connective tissue disease involving the skin, such as scleroderma or lupus
  • pregnancy
  • tumors that are larger than 5 cm that cannot be shrunk by neoadjuvant therapy

Certain criteria preclude a patient from having BCS. The lumpectomy, including any possible re-excisions, must be able to remove all of the cancer. For patients who wish to have BCS but who are not eligible at the time of diagnosis, the use of neoadjuvant (prior to surgery) therapy to reduce the size of the tumor may allow for BCS without compromising survival outcomes.4 5

For women with early-stage breast cancer, clinical studies have demonstrated similar survival rates with BCS plus radiation therapy as for mastectomy but with better cosmetic results.6 BCS is usually performed as an outpatient procedure under general or local anesthesia.

Mastectomy

Mastectomy is a surgical procedure that removes the entire breast. It is usually recommended for women with more advanced breast cancer or for women who otherwise do not meet criteria for breast conserving surgery. Women with early stage breast cancer also have the option of selecting a mastectomy. In addition, mastectomy for the purpose of preventing breast cancer (i.e., prophylactic mastectomy) is available to women who have not been diagnosed with breast cancer but are at increased risk due to a strong family history or known genetic predisposition.7

The most common type of mastectomy performed today is the total mastectomy.

The radical mastectomy, once very common, is rarely performed today. Also called the Halsted mastectomy, this procedure involved the removal of the breast, all surrounding lymph nodes, and the underlying chest muscles. The modified radical mastectomy includes complete removal of the breast and the underlying fascia of the chest muscles, along with the removal of the level I and II axillary lymph nodes. This type of mastectomy has an equivalent survival rate as the radical mastectomy.7

The most common type of mastectomy performed today is the total or simple mastectomy. The procedure involves the removal of the breast, nipple, areola, and a variable amount of the skin of the breast. Total mastectomy preserves the pectoral muscles and the axillary contents with the use of a sentinel lymph node dissection. The total mastectomy has been proven equally effective for treating breast cancer and is less disfiguring. It also maintains the function of the chest wall muscles.3 7

The skin-sparing mastectomy preserves most of the skin of the breast (not including the nipple and areola) and is used when the patient plans to have immediate breast reconstruction. It is considered safe and acceptable for noninvasive breast cancer, and stage I, II, or III breast cancer.3 7

The nipple-areolar sparing mastectomy preserves the skin of the nipple but removes the major ducts of the nipple lumen. This approach is only used for carefully selected patients, particularly those who choose mastectomy for prophylactic reasons who are having immediate reconstruction.7

All women undergoing a mastectomy should be informed of their options for breast reconstruction prior to surgery. Most mastectomies require short hospital stays, usually no more than two days.

The healthcare provider is an important resource for locating support groups and/or mental health professionals to help a woman and her family adjust to losing a breast. The American Cancer Society (ACS) offers a Reach to Recovery program that relies on carefully selected, trained survivors to help women cope with treatment-related issues. For more information about this program, please visit the ACS web site, or call 1-800-ACS-2345.

Lymph Node Removal and Analysis

Lymph nodes are removed and analyzed, usually during the BCS or mastectomy, to help determine whether cancer has spread past the breast and to guide the course of therapy.

The two primary methods of lymph node removal are axillary lymph node dissection (ALND) and sentinel lymph node dissection (SLND). The initial method used depends upon whether spread to the lymph nodes is suspected prior to surgery. If the nodes are clinically suspicious, then a needle biopsy of the nodes may be performed. If the biopsy is positive, the patient will have ALND. If the biopsy is negative, then SLND can be performed.5

Axillary lymph node dissection (ALND) is a procedure in which multiple lymph nodes are surgically removed from under the arm and microscopically examined for evidence of cancer. ALND can be associated with a number of chronic side effects including pain, wound infection, limited shoulder motion, numbness, and lymphedema (a chronic swelling of the arm caused by an accumulation of lymphatic fluid).3

Sentinel lymph node dissection (SLND) is based on the idea that cancer cells spread in an orderly way from the primary tumor.  A dye or radioactive substance is injected, and lymphatic vessels carry this substance to the first nodes to which a tumor is likely to drain. These nodes, called the sentinel lymph nodes (usually two or three), are then removed and checked for cancer. This is now the preferred procedure for patients without suspected lymph node involvement because it poses a lower risk of side effects than ALND.

If there is no cancer in the sentinel nodes, it is highly unlikely that the cancer has spread to other lymph nodes, so no further lymph node surgery is needed. If the sentinel nodes are positive for cancer, some patients will require a complete ALND. Some patients with positive sentinel nodes, however, may not require an ALND. Patients, for example, who have had breast conserving surgery, have smaller tumors, and are planning to have radiation therapy to the chest wall and axilla and patients who have undergone mastectomy whose sentinel nodes contain only micrometastic disease may not require further lymph node surgery.3 7

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Radiation Therapy

Radiation therapy is almost always recommended for use after lumpectomy to destroy any remaining undetected cancer cells in the breast, chest wall, or axilla.

Radiation therapy uses high-energy X-rays or other types of radiation to destroy cancer cells. It may be used before surgery, after surgery (breast conserving surgery or mastectomy), and as palliative care.

When used before surgery, radiation is referred to as neoadjuvant or preoperative radiation. Neoadjuvant radiation aims to reduce the size or extent of a tumor prior to surgery in order to make complete removal more likely. When used after surgery, radiation therapy is referred to as adjuvant therapy. Adjuvant radiation therapy is almost always recommended for use after breast conserving surgery to destroy any remaining undetected cancer cells in the breast, chest wall, or axilla. In such cases, radiation has been shown to reduce the risk of recurrence and positively impact survival.8

Radiation may also be recommended after mastectomy for patients with a high risk of recurrence, including those with large-sized tumors, positive axillary lymph nodes, and positive deep margins.8 For patients with advanced cancer, palliative radiation may be used to relieve pain and other symptoms but without altering the course of the disease.9

Delivery Methods

There are three main delivery methods with radiation therapy: external beam, brachytherapy, and intraoperative.

External beam radiation therapy delivers high-energy x-rays from an external source. It is the most common type of radiation therapy used with breast cancer. This method targets a precise beam of radiation to the area of the body affected by cancer with minimal impact on adjacent tissues. When used postoperatively, radiation therapy usually begins one month after surgery. It is generally administered five times per week for five to seven weeks, and treatments usually last less than 30 minutes. Research has begun to explore the effectiveness of shorter periods of radiation; a reduction to three weeks of radiation therapy may be an alternative for select patients.10 11

Brachytherapy places a radioactive source inside the body close to the site of the surgical removal or into the tumor mass. This allows for a higher dose of radiation to a smaller area. Interstitial brachytherapy delivers radiation through small, hollow catheters inserted directly into the tissue in the area where the cancer was removed. Intracavitary brachytherapy uses a small catheter which is inserted into the space left after breast conserving surgery. For both methods, the catheters are left in place for several days and radioactive pellets are inserted for short periods of time each day and then removed. Brachytherapy is usually given twice a day for five days on an outpatient basis. The catheters are removed after the last treatment.11

Intraoperative radiation therapy delivers a single dose of radiation on the same day as a patient’s surgery with a goal of minimizing toxicity while maintaining effectiveness. Currently, this type of therapy is only used in clinical trials because it is associated with a higher risk of recurrence, prolonged surgery time, and lack of final pathological information.8 10

Whole Breast Radiation and Accelerated Partial Breast Irradiation Therapy

Whole breast radiation therapy (WBRT) targets the entire breast using external beam radiation. This type of radiation therapy reduces the risk of recurrence and increases survival and is recommended for most women who have undergone breast conserving surgery. An extra boost of radiation may be given at the site of the tumor bed following WBRT.

Accelerated partial breast irradiation therapy (APBI) is a form of radiation therapy in which focused radiation is delivered only to the area immediately surrounding the tumor site instead of the whole breast. APBI delivers a higher dose of radiation over a shorter period of time and can be delivered via external beam radiation, brachytherapy, or intraoperative radiation. APBI may be used for women with early breast cancer who have had breast conserving surgery and may be a suitable treatment option for women who are at least 45 years old with small, lymph node negative tumors with negative surgical margins.10

Side Effects of Radiation Therapy

The most common side effect of radiation therapy is fatigue. Other temporary side effects include swelling or heaviness in the breast, sunburn-like changes in the skin, and loss of appetite. Toward the end of treatment, the irradiated skin may feel moist and sore. In some women, the treated breast may become smaller or firmer. In a small percentage of cases, lymphedema is possible with radiation of the axilla. Most women are able to carry on daily activities while undergoing radiation therapy. Radiation is not used for women who are pregnant.11

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Chemotherapy

Chemotherapy uses cytotoxic drugs to kill and prevent the growth of cancer cells. It can be used as a form of adjuvant, neoadjuvant, or palliative therapy. Chemotherapy may also be used as the primary treatment for managing metastatic or recurrent breast cancer. Whether or not a patient receives chemotherapy and what kind depends on the woman’s age and the characteristics of her breast cancer, including the size of the tumor and hormone and HER-2/neu (also known as HER2) receptor status.4 An online tool is now available at Adjuvant! Online to help healthcare providers and women with early stage breast cancer discuss the risk and benefits of chemotherapy, hormone therapy (see below), or both after surgery.

In contrast to radiation therapy and surgery, which are local therapies, chemotherapy is a systemic mode of treatment that affects tissues and organs throughout the entire body. It is the role of the medical oncologist to determine which combination of drugs will be used and their order, dose, and frequency.

Chemotherapy is usually given as a combination of drugs, which has been shown to be more effective than any one single drug. The specific combination is tailored to the individual patient. A women's age, medical history, overall health, and tumor characteristics will factor into the planning of her specific regimen.12

The most common drugs used for breast cancer chemotherapy combination treatment include anthracyclines, such as doxorubicin (Adriamycin) and epirubicin (Ellence) and the taxanes such as paclitaxel (Taxol) and docetaxel (Taxotere).12 For a full listing of chemotherapy agents and their recommended use, see the National Comprehensive Cancer Network Guidelines for Breast Cancer. Another resource is the National Cancer Institute’s Cancer Drug Information page, which lists drugs approved by the FDA for breast cancer.

Chemotherapy is most often delivered intravenously through a catheter placed into a vein on the hand or lower arm. It can also be delivered by IV through ports and pumps or injected into the muscle (intramuscularly) or under the skin (subcutaneously). In addition to these delivery methods, some chemotherapy drugs are given orally.12

Chemotherapy is administered in cycles, with each cycle of treatment usually followed by a rest period. Cycles are usually 2 or 3 weeks long but vary according to the drug or combination of drugs. Adjuvant and neoadjuvant chemotherapy is generally given for a total time period of 3 to 6 months, depending on which drugs are used. Treatment may be longer for advanced breast cancer. Most patients receive their treatment as an outpatient.2 12

Chemotherapy Drugs.  Source: Adapted from NCI Visuals Online. AV-9310-4147.

The side effects of chemotherapy depend on the types of drugs used, the dosages, and the duration of treatment. Most of the side effects associated with chemotherapy are temporary. Common side effects are nausea and vomiting, hair loss (alopecia), and fatigue (sometimes due to low red blood cell counts). Other side effects include oral ulcerations, flu-like symptoms after treatment, bruising or bleeding after minor cuts (from lower blood platelets), and/or infection (from lower white blood cells), among others. Permanent side effects can include early menopause and infertility. In addition, many women report having problems with memory and/or mental clarity after having had chemotherapy. This condition, also known as "chemo brain," can linger for varying lengths of time after the course of chemotherapy is completed.12

There are a number of excellent medicines for managing side effects from chemotherapy. The American Cancer Society (ACS) website offers a helpful section to which providers may refer their patients for learning about various methods for Managing Side Effects of Chemotherapy. Knowing what to expect before treatment begins will help patients through the experience.

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Hormone Therapy

Hormone therapy is a cancer treatment that either removes hormones or blocks their action in order to stop cancer cells from growing.

Hormone therapy (also called endocrine therapy) is a cancer treatment that either removes hormones or blocks their action in order to stop cancer cells from growing. This form of therapy is based upon the recognition that estrogen and progesterone stimulate the growth of breast cancer cells. When this action is interrupted, the cancer cells that depend upon these hormones stop growing and die. As such, hormone therapy is only effective in treating women whose cancers are estrogen and/or progesterone receptor positive.13

Hormone therapy may be used in addition to surgery and radiation therapy. It may also be used with chemotherapy. In addition, women at high risk of developing breast cancer may be offered hormone therapy as an effective method of risk reduction. Hormonal medicines may be given alone, in combination, or sequentially. There are several types of hormone therapies used in the treatment of breast cancer. They are known as selective estrogen receptor modulators, estrogen receptor antagonists/downregulators, aromatase inhibitors, drug-induced ovarian ablation, progestins, androgens, and estrogens.

Selective estrogen receptor modulators (SERMs) (e.g., tamoxifen (Nolvadex), raloxifene (Evista), and Toremifene (Fareston)) are a type of antiestrogen that work by binding to estrogen receptors selectively, stimulating or inhibiting the estrogen receptors of different target tissues.13

Tamoxifen is a SERM used for treating breast cancer with both pre- and post-menopausal women, in early and advanced disease, and with invasive and noninvasive types of breast cancers. It is the most widely used hormone therapy in the treatment of breast cancer.

Tamoxifen is also used effectively for decreasing the likelihood of breast cancer in women at high risk. However, side effects associated with tamoxifen can be serious, including increased risk for uterine cancer, blood clots, strokes, and cataracts.13

Raloxifene, also a SERM, is an effective alternative to tamoxifen for postmenopausal women at increased risk and has fewer side effects. It is approved for the prevention of breast cancer in postmenopausal women with osteoporosis at high risk for invasive breast cancer, but is not currently utilized as a breast cancer treatment. 13 14

Toremifene (Fareston) is a SERM similar to tamoxifen but is only approved to treat metastatic cancer.13

Selective estrogen-receptor antagonists/downregulators (SERDs) (e.g., fulvestrant (Faslodex)) are similar to SERMs, in that they bind to the estrogen receptors of cells and interfere with the process of cell proliferation. SERDS, however, act like an anti-estrogen throughout the body. Currently, fulvestrant is the only FDA-approved SERD for treatment of breast cancer. It is frequently used to treat postmenopausal women with advanced cancer who no longer respond to tamoxifen. Compared with tamoxifen, fulvestrant is well tolerated although it is associated with some side effects, including nausea and fatigue.13 15

Aromatase inhibitors (e.g., letrozole (Femara), anastrazole (Arimidex), and exemestane (Aromasin)) prevent the formation of estrogen by inhibiting the action of the aromatase enzyme which converts androgens into estrogens by a process called aromatization. Aromatase inhibitors eliminate all of the body's estrogen in postmenopausal women. In premenopausal women, this group of drugs is ineffective since most of their estrogen is produced from the ovaries. Aromatase inhibitors (AIs) are used for treating postmenopausal women, either as initial therapy or after tamoxifen. Side effects associated with AIs are generally mild and include joint and muscle pain. Long term use, however, may lead to osteoporosis. The use of aromatase inhibitors, either alone or after tamoxifen, has been shown to better reduce risk of recurrence than the use of tamoxifen alone. Postmenopausal women with hormone receptor-positive breast cancer are generally recommended to use an aromatase inhibitor at some point during adjuvant therapy.13

Ovarian ablation (e.g., goserelin (Zoladex) or leuprolide (Lupron)) stops the ovaries from producing estrogen. Also called ovarian suppression, this form of therapy is used with premenopausal women, in whom ovaries are the main source of the body's estrogen. Traditionally, ovarian ablation involves surgery (oophrectomy) or radiation, but ovarian produced estrogen can now be suppressed by drugs called luteinizing hormone-releasing hormone (LHRH) agonists, such as goserelin. Hormone agonists work by inhibiting the signaling of LHRH, so that the body's production of estrogen is reduced. Possible side effects include hot flashes, decreased sexual desire, absence of menstruation, vaginal dryness, and breast swelling or tenderness.13

Progestins (e.g., megestrol (Megace)) are used as a second- or third-line treatment in women with advanced breast cancer when treatment with tamoxifen or an aromatase inhibitor has failed. Common side effects are fluid retention, weight gain, and thromboembolic events.13 15

Androgens are male hormones that are occasionally used for the treatment of advanced breast cancer after other hormone treatments have failed. The primary side effects are the development of masculine characteristics such as body hair and a deeper voice. 13 15

Estrogens in high doses are another option sometimes considered for advanced breast cancer that is not responsive to other hormone therapies. The main risk with this drug is serious blood clots, and a primary side effect is nausea.13 15

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Targeted Therapy

Targeted therapy is directed at specific targets in the body (cellular receptors, proteins and enzyme systems) to help fight cancer

Targeted therapy is directed at specific targets in the body (cellular receptors, proteins, and enzyme systems) to help fight cancer. Other terms used for this type of therapy are biological response modifier therapy and biological therapy.

Monoclonal Antibodies.  Source: Linda Bartlett (photographer). Adapted from NCI Visuals Online. AV-8000-0368.

HER-2/neu Directed Therapies

Trastuzumab (Herceptin), a monoclonal antibody, has been used since 1998 to treat certain cases of advanced breast cancer by targeting cancer cells that make excessive amounts of the protein HER2. Approximately 20% of breast cancers test positive for the overexpression of HER2.16

Ado-trastuzumab emtansine (TDM-1, Kadcyla) is made up of the same monoclonal antibody as trastuzumab and is attached to a chemotherapy drug known as DM-1. Ado-trastuzumab takes the DM-1 directly to the cancer cells and is used to treat advanced breast cancer.16

Pertuzumab (Perjecta) is also a monoclonal antibody that attaches to the HER2 protein but seems to target a different part of the protein than trastuzumab. It is frequently used in combination with other chemotherapy drugs.16

Lapatinib (Tykerb) also targets HER2. It is used for women with advanced HER2-positive breast cancer usually in combination with other drugs.16

Each of these drugs has potentially serious side effects, including heart muscle damage and allergic reactions.

Many studies have found HER2 targeted therapies to be highly effective in the treatment of HER2-positive early stage and metastatic breast cancer. When combined with chemotherapy, these targeted therapies improve both survival rates and rates of recurrence for women with HER2- positive breast cancer when compared to systemic chemotherapy alone.17 18

Everolimus (Afinitor)

Everolimus blocks mTOR, a protein in the cells that normally promotes cell growth, which can help stop cancer cells from growing. It may also prevent tumors from developing new blood vessels. This drug seems to help hormone therapy drugs work better and is approved for hormone receptor-positive, HER2- negative, breast cancer in postmenopausal women whose cancers have grown while being treated with letrozole or anastrazole. It is meant to be used with exemestane. Serious side effects include an increase in blood lipids and blood sugars.16

Bevacizumab (Avastin)

Bevacizumab is a monoclonal antibody that targets vascular endothelial growth factor, a protein that helps tumors form blood vessels. This drug has been widely used for treatment of metastatic triple negative breast cancer, but has serious side effects including high blood pressure and blood clots. Although bevacizumab slows cancer growth in the short-term, it does not seem to impact survival for breast cancer patients. Therefore, in 2011, the FDA withdrew its approval for using bevacizumab for breast cancer. It is still occasionally used “off-label” for breast cancer patients since it is still approved to treat some other cancers.16

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Treatment Options by Stage

Treatment options for breast cancer vary depending on the stage of disease. A number of organizations offer detailed treatment guidelines for practitioners and patients according to the stage of the breast cancer. Guidelines include: (1) The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology and Step-By-Step Treatment Guide for patients; 19 (2) The National Cancer Institute (NCI) Physician Data Query(PDQ) series for health professionals 6and NCI PDQ for patients;20 and (3) The American Cancer Society Breast Cancer Detailed Guide. 21 22

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Clinical Trials

All aspects of breast cancer management - screening, prevention, diagnosis, and treatment - are researched in clinical trials.

Clinical trials are research studies that test new medical approaches with volunteer patients. They are the means by which the safety and efficacy of new treatments and methods are evaluated before becoming a part of standard medical protocol. All aspects of breast cancer management - screening, prevention, diagnosis, and treatment - are researched in clinical trials. Patients who participate in these studies not only obtain expert care from a leading medical facility but may also gain access to potentially more effective therapies. They are also helping others by contributing to research that may lead to significant medical advances.

There are three phases of clinical trials in which a treatment or method is studied before it can be approved by the FDA for widespread use.

  • Phase I trials test an experimental drug or treatment in a small group of people (15-30) for the first time to determine a safe dosage range, to decide how a new treatment should be given, and to see how the treatment affects the human body.
  • Phase II trials study the drug or treatment with a larger group of people (less than 100) to determine whether it is effective and to see how it affects the human body.
  • Phase III trials study the drug or treatment with large groups of people (from 100-several thousand) to compare the new treatment (or new use of a treatment) with the current standard treatment.23
Research Lab.  Source: Diane A. Reid, Photographer. Adapted from NCI Visuals Online.

Each clinical trial is unique. When talking with patients about the potential benefits and risks of participation, health providers should thoroughly explain the purpose of the trial, the type of tests and treatments involved, and how these compare with the standard approaches. Patients considering participation will also need to know how long the trial will last, how often and where treatments will be administered, who will be in charge of their care during the trial, and what the long-term follow-up will be. If financial costs are involved, patients need to know whether or not such costs are covered by insurance, and if not, whether financial aid is available. Most important, patients will want to know if the experimental treatment is working. What will they be told about this and when?

Many patients with breast cancer will learn about clinical trials from their oncologists, surgeons, radiologists, and other medical specialists on their cancer care team. Primary care providers can also help connect the patient with appropriate clinical trial information by knowing about several key registries available online.

  • NCI's Clinical Trials Registry contains abstracts of clinical trials that have been completed or closed. Most studies within the database are sponsored by NCI but the registry also includes trials sponsored by pharmaceutical companies, medical centers, and other groups from around the world. Clinical trials can be found using the Find NCI-Supported Clinical Trials search form .
  • ClinicalTrials.gov provides regularly updated information about federally and privately supported clinical trials. Cancer trials registered with NCI will automatically be registered in ClinicalTrials.gov and vice versa, but users may prefer the unique search features of one source over the other.
  • The TrialCheck®! search tool continuously imports information for all cancer clinical studies registered with the US Government Department of Health and Human Services. This tool can be used to find individually tailored information on clinically appropriate, open and enrolling trials.
  • The American Cancer Society Clinical Trial Matching Service is designed with a user-friendly question and answer format for patients and their caregivers. Registration is required; however, all information is held confidential and the matching service is free of charge. At the patient's request, an ACS Information Specialist will contact the patient by phone or by email with additional information about one or more trials.
  • The American Association for Cancer Research identifies clinical trials that match specific diagnosis, stage, and treatment history. If a match is found, the AACR will assign the patient a Clinical Trials Navigator to connect the patient with the trials and locations that are most appropriate and convenient.

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Notes

Show References Hide References
  1. Centers for Disease Control and Prevention. (n.d.). Breast and Cervical Cancer Prevention and Treatment Act of 2000. Retrieved from: http:///www.cdc.gov/cancer/nbccedp/legislation/law106-354.htm
  2. National Cancer Institute. (2009, June 16). Adjuvant and neoadjuvant therapy for breast cancer. Retrieved from: http:///www.cancer.gov/cancertopics/factsheet/Therapy/adjuvant-breast
  3. American Cancer Society. (2014, January 31). Surgery for breast cancer. Retrieved from: http:///www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-treating-surgery
  4. National Comprehensive Cancer Network.(2014). NCCN guidelines for patients®: breast cancer. Retrieved from: http:///www.nccn.org/patients/guidelines/stage_i_ii_breast/index.html#1
  5. Taghian, A., El-Ghamry, M. N, & Merajver, S. D. (2013, April 3). Overview of the treatment of newly diagnosed, non-metastatic breast cancer. Retrieved from the Up to Date website: http:///www.uptodate.com/contents/overview-of-the-treatment-of-newly-diagnosed-non-metastatic-breast-cancer
  6. National Cancer Institute. (2014, January 31). Breast cancer treatment (PDQ®).Health professional version. Retrieved from: http:///www.cancer.gov/cancertopics/pdq/treatment/breast/healthprofessional
  7. Kwong, A., & Sabel, M. S. (2014, January 23). Mastectomy: indications, types, and concurrent axillary lymph node management. Retrieved from the Up to Date website: http:///www.uptodate.com/contents/mastectomy-indications-types-and-concurrent-axillary-lymph-node-management
  8. Pierce, L. J. (2013, December 18). Adjuvant radiation therapy for women with newly diagnosed, non-metastatic breast cancer. Retrieved from the Up to Date website: http:///www.uptodate.com/contents/adjuvant-radiation-therapy-for-women-with-newly-diagnosed-non-metastatic-breast-cancer
  9. National Cancer Institute. (2010, June 30). Radiation therapy for cancer. Retrieved from: http:///www.cancer.gov/cancertopics/factsheet/Therapy/radiation
  10. Pierce, L. (2013, October 21). Radiation therapy techniques for newly diagnosed, non-metastatic breast cancer. Retrieved from the Up to Date website: http:///www.uptodate.com/contents/radiation-therapy-techniques-for-newly-diagnosed-non-metastatic-breast-cancer
  11. American Cancer Society. (2013, September 11). Radiation therapy for breast cancer. Retrieved from: http:///www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-treating-radiation
  12. American Cancer Society. (2014, January 31). Chemotherapy for breast cancer. Retrieved from: http:///www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-treating-chemotherapy
  13. American Cancer Society. (2014, January 31). Hormone therapy for breast cancer. Retrieved from: http:///www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-treating-hormone-therapy
  14. National Cancer Institute. (2013, July 3). FDA approval for Raloxifene Hydrochloride. Retrieved from: http:///www.cancer.gov/cancertopics/druginfo/fda-raloxifene-hydrochloride
  15. Ellis, M., Naughton, M. J., & Ma, C. X. (2014, January 8). Treatment approach to metastatic hormone receptor-positive breast cancer: endocrine therapy. Retrieved from the Up to Date website: http:///www.uptodate.com/contents/treatment-approach-to-metastatic-hormone-receptor-positive-breast-cancer-endocrine-therapy
  16. American Cancer Society. (2013, September 11). Targeted therapy for breast cancer. Retrieved from: http:///www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-treating-targeted-therapy
  17. Harris, C. A., Ward, R. L., Dobbins, T. A., Drew, A. K., & Pearson, S. (2011). The efficacy of HER2-targeted agents in metastatic breast cancer: a meta-analysis. Annals of Oncology, 22(6), 1308-1317. doi: 10.1093/annonc/mdq593
  18. Dahabreh, I. J, Linardou, H., Siannis, F., Fountzilas, G., & Murray, S. (2008). Trastuzumab in the adjuvant treatment of early-stage breast cancer: a systematic review and meta-analysis of randomized controlled trials. The Oncologist, 13(6), 620-630. doi: 10.1634/theoncologist.2008-0001
  19. National Comprehensive Cancer Network. (2014). NCCN guidelines version 1.2014. Breast cancer. Retrieved from: http:///www.nccn.org
  20. National Cancer Institute.(2013, October 18). Breast cancer Treatment (PDQ®). Patient version. Retrieved from: http:///www.cancer.gov/cancertopics/pdq/treatment/breast/Patient
  21. American Cancer Society. (2013, September 11). Treatment of non-invasive (stage 0) breast cancer. Retrieved from: http:///www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-treating-stage0
  22. American Cancer Society. (2013, September 11). Treatment of invasive breast cancer, by stage. Retrieved from: http:///www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-treating-by-stage
  23. National Cancer Institute. (2012, November 2). Learn about clinical trials. Retrieved from: http:///www.cancer.gov/clinicaltrials/learningabout/what-are-clinical-trials/phases

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Last updated: March 14, 2014

The Breast Cancer Review is sponsored by the Department of Health Care Services (DHCS), Every Woman Counts (EWC) program, with the goal of providing healthcare professionals a general reference for breast cancer screening, diagnosis, and treatment. The Breast Cancer Review is not an expression of medical opinion, diagnosis, prognosis or treatment recommendation for any particular patient. It should be used for informational purposes only. EWC does not dispense clinical advice or patient care consultation. Links to other web resources are offered as a courtesy; no endorsement is made or implied.  While every care has been taken in their selection, EWC makes no claims as to the validity, quality, or viability of their content.

 

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