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Breast Cancer Clinical Trials

This list includes current clinical trials for Breast Cancer offered through Dana-Farber Cancer Institute and other Dana-Farber/Harvard Cancer Center institutions.

  1. Bevacizumab and Paclitaxel, Paclitaxel Albumin-Stabilized Nanoparticle Formulation, or Ixabepilone in Treating Patients With Stage IIIC or Stage IV Breast Cancer

    RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as paclitaxel, paclitaxel albumin-stabilized nanoparticle formulation, and ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which treatment regimen is more effective in treating patients with breast cancer. PURPOSE: This randomized phase III trial is studying bevacizumab to see how well it works when given together with paclitaxel, paclitaxel albumin-stabilized nanoparticle formulation, or ixabepilone in treating patients with stage IIIC or stage IV breast cancer.
    Phase: Phase 3
    Diagnosis: Breast Cancer

  2. Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)

    RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hormone therapy together with more than one chemotherapy drug (combination chemotherapy) has been shown to reduce the chance of breast cancer recurrence, but the benefit of adding chemotherapy to hormone therapy for women with node-negative, estrogen-receptor positive breast cancer is small. New tests may provide information about which patients are more likely to benefit from chemotherapy. PURPOSE: This randomized phase III trial is trying to find out the best individual therapy for women who have node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype DX), and whether hormone therapy alone or hormone therapy together with combination chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25.
    Phase: Phase 3
    Diagnosis: Breast Cancer

  3. Tamoxifen or Letrozole With or Without Bevacizumab in Treating Women With Stage III or Stage IV Breast Cancer

    RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen or letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving hormone therapy is more effective with or without bevacizumab in treating advanced breast cancer. PURPOSE: This randomized phase III trial is studying giving tamoxifen or letrozole together with bevacizumab to see how well it works compared with tamoxifen or letrozole alone in treating women with stage III or stage IV breast cancer.
    Phase: Phase 3
    Diagnosis: Breast Cancer

  4. Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

    RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer. PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer.
    Phase: Phase 3
    Diagnosis: Breast Cancer

  5. Fulvestrant With or Without Lapatinib in Treating Postmenopausal Women With Stage III or Stage IV Breast Cancer That is Hormone Receptor-Positive

    RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes. Lapatinib may stop the growth of breast cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether fulvestrant is more effective with or without lapatinib in treating breast cancer. PURPOSE: This randomized phase III trial is studying fulvestrant and lapatinib to see how well they work compared to fulvestrant and a placebo in treating postmenopausal women with stage III or stage IV breast cancer that is hormone receptor-positive.
    Phase: Phase 3
    Diagnosis: Breast Cancer

  6. Cyclophosphamide and Doxorubicin or Paclitaxel in Treating Women With Breast Cancer

    RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether giving cyclophosphamide together with doxorubicin is more effective than giving paclitaxel alone in treating breast cancer. PURPOSE: This randomized phase III trial is studying cyclophosphamide and doxorubicin to see how well they work compared to paclitaxel in treating women with invasive breast cancer.
    Phase: Phase 3
    Diagnosis: Breast Cancer

  7. Exemestane in Preventing Cancer in Postmenopausal Women at Increased Risk of Developing Breast Cancer

    RATIONALE: Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen and progesterone. PURPOSE: This randomized phase III trial is studying exemestane to see how well it works in preventing cancer in postmenopausal women who are at increased risk of developing breast cancer.
    Phase: Phase 3
    Diagnosis: Breast Cancer

  8. Telephone-Based Genetic Counseling or Standard Genetic Counseling in Women at Risk of Carrying the BRCA1 or BRCA2 Mutation

    RATIONALE: Genetic counseling may work as well over the telephone as it does in-person. It is not yet known whether genetic counseling by telephone is more effective than standard (in-person) genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation. PURPOSE: This randomized phase III trial is studying telephone-based genetic counseling to see how well it works compared to standard (in-person) genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation.
    Phase: Phase 3
    Diagnosis: Breast Cancer

  9. Suppression of Ovarian Function Plus Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

    RATIONALE: Estrogen can stimulate the growth of breast tumor cells. Ovarian function suppression combined with hormone therapy using tamoxifen or exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known whether suppression of ovarian function plus either tamoxifen or exemestane is more effective than tamoxifen alone in preventing the recurrence of hormone-responsive breast cancer. PURPOSE: This randomized phase III trial is studying ovarian suppression with either tamoxifen or exemestane to see how well they work compared to tamoxifen alone in treating premenopausal women who have undergone surgery for hormone-responsive breast cancer.
    Phase: Phase 3
    Diagnosis: Breast Cancer

  10. Early Detection and Intervention for Mild and Moderate Lymphedema in Patients Treated for Breast Cancer

    Women who have been treated for breast cancer may be at risk for lymphedema or arm swelling. Currently, there are no clear treatment guidelines for lymphedema. One treatment method used to treat lymphedema is the use of compression sleeves to encourage the flow of lymph fluid out of the arms and prevent arm swelling in the future. Another treatment method is more intensive and involves wearing compression sleeves as well as special compression bandages overnight. It is unclear whether the use of compression with both sleeves and bandaging is more effective in treating lymphedema than the use of compression sleeves alone. The purpose of this research study is to evaluate the effectiveness of the use of compression garments in preventing or slowing the progression of lymphedema in breast cancer patients.
    Phase: Phase 3
    Diagnosis: Breast Cancer

  11. Lapatinib in Combination With Trastuzumab in Patients With HER2-Positive, Metastatic Breast Cancer

    In this research study we are studying the effects of the combination of lapatinib plus Herceptin in subjects with breast cancer that has spread outside of the breast. We are also studying whether positron emission tomography (PET/CT) scans can predict which participants will benefit from the study treatment. Finally, we are studying genes and proteins in the tumor tissue that may lead to sensitivity or resistance to Herceptin, and to the combination of Herceptin plus lapatinib. Lapatinib is a compound that may stop cancer cells from growing. Other research studies suggest that lapatinib in combination with Herceptin may help to shrink or stabilize breast cancer.
    Phase: Phase 2
    Diagnosis: Breast Cancer

  12. Extended Endocrine Therapy for Premenopausal Women With Breast Cancer

    The purpose of this study is to determine the safety and tolerability of the combination of two drugs (letrozole and leuprolide) in women who have already taken tamoxifen for at least 4.5 years. Letrozole, an aromatase inhibitor (which blocks an enzyme that produces estrogen), is a drug that is FDA approved. It has been shown to reduce the risk of breast cancer recurrence in postmenopausal women with breast cancer who have been previously treated with tamoxifen. Letrozole works by stopping the production of estrogen in parts of the body other than the ovaries. Leuprolide is a drug that stops a women's ovarian cycles. This process is known as ovarian function suppression. Stopping a women's menstrual cycle may be highly effective against breast cancer for some patients when given as initial therapy. The combination of letrozole and leuprolide is considered a standard treatment for women with metastatic breast cancer, and is also sometimes used for treatment of early stage breast cancer. However, it has not been accepted as a standard of care treatment.
    Phase: Phase 2
    Diagnosis: Breast Cancer

  13. Platinum for Triple-Negative Metastatic Breast Cancer and Evaluation of p63/p73 as a Biomarker of Response

    The purpose of this research study is to : - Determine how effective cisplatin or carboplatin is in slowing the time it takes for ER negative, PR negative, HER2 negative breast cancer to progress. Cisplatin and carboplatin are anti-cancer chemotherapy drugs that stop cancer cells from growing abnormally and is used to treat other cancers. - Evaluate a new biomarker to help determine which breast cancers are most likely to respond to cisplatin chemotherapy The hypothesis is that Triple Negative metastatic breast cancer may be particularly sensitive to platinum, and that a subgroup of those patients may have a marker in their tumors that predicts response.
    Phase: Phase 2
    Diagnosis: Breast Cancer

  14. ZK219477 in Patients With Breast Cancer and Brain Metastases

    The purpose of this research study is to determine the effects (good and bad) of ZK219477 on participants and their cancer. ZK219477 is a chemotherapy drug that is thought to work by interfering with the ability of cancer cells to grow and divide. It is a part of a group of drugs called "epothilones" which appear to cause shrinkage of cancer in some patients with breast cancer. It is generally difficult for chemotherapy to enter the brain. However, it is believed that ZK219477 crosses into the brain. We are also studying whether an investigational MRI scan procedure may eventually help to predict which patients will benefit from ZK219477.
    Phase: Phase 2
    Diagnosis: Breast Cancer, Brain/Neuro Cancer

  15. Comparing Letrozole Given Alone to Letrozole Given With Avastin in Post-Menopausal Women Breast Cancer

    This purpose of this trial is to show that the combination of Avastin and hormone therapy should be more effective than hormone therapy alone for the treatment of breast cancer.
    Phase: Phase 2
    Diagnosis: Breast Cancer

  16. Preoperative Dose-dense Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Bevacizumab in Operable Breast Cancer

    Dose dense chemotherapy, which is the term for Adriamycin and Cyclophosphamide (AC) followed by Taxol chemotherapy given every two weeks, is the standard chemotherapy for the treatment of ER+ or PR+ breast cancer. In this trial, the standard chemotherapy is being combined with bevacizumab. Bevacizumab is an antibody which works differently from the way other chemotherapy drugs work. Bevacizumab slows or stops cell growth in cancerous tumors by decreasing the blood supply to the tumors by binding to a substance found on cancer cells called VEGF (vascular endothelial growth factor). Bevacizumab is approved by the FDA for the treatment of colorectal cancer and lung cancer. However, it is not approved for the treatment of breast cancer. Another goal of this research is to determine whether we can develop a way to identify tumors that will respond well to this study treatment.
    Phase: Phase 2
    Diagnosis: Breast Cancer

  17. Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer

    The purpose of this study is to find out what effect the postoperative combination of therapies: trastuzumab (herceptin) and paclitaxel (taxol) will have on breast cancer recurrence. A combination of trastuzuamb and chemotherapy has been used in women with node positive and high risk node negative disease. This tests utilizes a well tolerated regimen of weekly paclitaxel and trastuzumab in women with T1, node negative tumors that are HER2 positive. We would like to determine how effective this drug combination is when used in women with early stage breast cancer, as well as to better define the side effects of this treatment.
    Phase: Phase 2
    Diagnosis: Breast Cancer

  18. Aromatase Inhibitors in Premenopausal Breast Cancer Patients With Chemotherapy-Induced Ovarian Failure

    Women with hormone-receptor positive breast cancer are typically treated with hormone therapy as part of their treatment after surgery. In the past few years it has been found that treatment with aromatase inhibitors is superior to tamoxifen in postmenopausal women. Tamoxifen is still used for premenopausal women, however, because aromatase inhibitors are not effective in women who have functioning ovaries. Some women are premenopausal at the time they are diagnosed with breast cancer, but then stop having menstrual periods when they are treated with chemotherapy. It is unclear if these women can also be treated safely with aromatase inhibitors. In this clinical trial the researchers will try to answer this question. Women with hormone receptor positive breast cancer who become postmenopausal with chemotherapy will be invited to participate in this study. Each woman will be treated with one of the aromatase inhibitors, anastrozole (Arimidex), and then carefully monitored to ensure that her ovaries do not start making estrogen. If her estrogen level remains low, then she will continued to be followed for 18 months. If the level increases to the level typically seen in premenopasual women, however, then she will stop taking part in this study. The study will also evaluate multiple factors that may help doctors predict who will tolerate the therapy without having their ovaries start making estrogen again. Some of the factors to be evaluated include other hormone levels (blood tests) as well as family history of early menopause (mother, sisters). In addition, changes in certain genes that affect how patients' bodies handle chemotherapy drugs will be tested to see if they affect whether or not patients recover ovarian function. Overall, the purpose of the study is to determine which patients who become postmenopausal from chemotherapy are likely to tolerate aromatase inhibitor treatment safely, and how often the patients' ovarian function needs to be tested during treatment.
    Phase: Phase 2
    Diagnosis: Breast Cancer

  19. Statins and Breast Cancer Biomarkers

    There is laboratory evidence that cholesterol lowering medications (statins) inhibit the growth of breast cancer cells. Clinical studies are controversial but some show that women taking statins are less likely to get breast cancer. This ongoing randomized trial compares one-year of atorvastatin (Lipitor™) or placebo for lowering mammography-defined breast density and other surrogate markers associated with breast cancer risk.
    Phase: Phase 2
    Diagnosis: Breast Cancer

  20. Intermittent Letrozole Therapy in Postmenopausal Women With Metastatic Breast Cancer

    The purpose of this research study is to study the effects of using aromatase inhibitor (AI) therapy intermittently on participants with breast cancer. AIs are a class of drugs used to treat breast cancer in postmenopausal women. They work by decreasing the level of estrogen, which is believed to stimulate the growth of tumor tissue. Breast cancer that progresses despite therapy with an AI is thought to have become resistant to AI therapy. There is scientific evidence to suggest that resistant breast cancer cells learn to grow at the very low levels of estrogen present on AI therapy, and that increasing estrogen levels even slightly by stopping AI therapy may inhibit the breast cancer cells.
    Phase: Phase 2
    Diagnosis: Breast Cancer

  21. Bevacizumab in Combination With Vinorelbine and Trastuzumab for HER2-Positive, Metastatic Breast Cancer

    The purpose of this research study is to determine the effects of the combination of bevacizumab, vinorelbine, and trastuzumab on participants and their cancer.
    Phase: Phase 2
    Diagnosis: Breast Cancer

  22. Letrozole and Lapatinib in Treating Postmenopausal Women With Stage I, Stage II, or Stage III Breast Cancer That Can Be Removed by Surgery

    RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving letrozole together with lapatinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This randomized phase II trial is studying how well giving letrozole together with lapatinib works in treating postmenopausal women with stage I, stage II, or stage III breast cancer that can be removed by surgery.
    Phase: Phase 2
    Diagnosis: Breast Cancer

  23. Epothilone B in Treating Patients With CNS Metastases From Breast Cancer

    RATIONALE: Drugs used in chemotherapy, such as epothilone B, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well epothilone B works in treating patients with CNS metastases from breast cancer.
    Phase: Phase 2
    Diagnosis: Brain/Neuro Cancer, Breast Cancer

  24. MPA Revisited: A Phase II Study of Anti-Metastatic, Anti-Angiogenic Therapy in Postmenopausal Patients With Hormone Receptor Negative Breast Cancer. A Translational Breast Cancer Research Consortium (TBCRC) Trial

    The purpose of this study is to evaluate the impact of MPA alone and in combination with low dose oral chemotherapy in patients with ER- and PR- advanced breast cancer.
    Phase: Phase 2
    Diagnosis: Breast Cancer

  25. Carboplatin and Bevacizumab for Progressive Breast Cancer Brain Metastases

    The purpose of this research study is to determine how well the combination of bevacizumab and carboplatin works in treating breast cancer that has spread to the brain. Bevacizumab is an antibody (a protein that attacks a foreign substance in the body) that is made in the laboratory. Bevacizumab works differently from the way chemotherapy drugs work. Usually chemotherapy drugs attack fast growing cancer cells in the body. Bevacizumab works to slow or stop the growth of cells in cancer tumors by decreasing the blood supply to the tumors. When the blood supply is decreased, the tumors don't get the oxygen and nutrients they need to grow. Carboplatin is in a class of drugs known as platinum-containing compounds and has been approved for use in the treatment of ovarian cancer. Information from other research studies suggests that the combination of bevacizumab with carboplatin may be effective in treating breast cancer.
    Phase: Phase 2
    Diagnosis: Breast Cancer

  26. Paclitaxel With or Without Carboplatin and/or Bevacizumab Followed By Doxorubicin and Cyclophosphamide in Treating Patients With Breast Cancer That Can Be Removed by Surgery

    RATIONALE: Drugs used in chemotherapy, such as paclitaxel, carboplatin, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving chemotherapy together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This randomized phase II trial is studying how well giving paclitaxel with or without carboplatin and/or bevacizumab followed by doxorubicin and cyclophosphamide works in treating patients with breast cancer that can be removed by surgery.
    Phase: Phase 2
    Diagnosis: Breast Cancer

  27. Efficacy and Safety of IPI-504 With Trastuzumab Pretreated, Locally Advanced or Metastatic HER2 Positive Breast Cancer

    The purpose of this study is to see if IPI-504 in combination with trastuzamab is an effective treatment in HER2 positive metastatic breast cancer
    Phase: Phase 2
    Diagnosis: Breast Cancer

  28. A Phase 1b/2a, Open-Label, Multi-Center Study of Tivozanib (AV-951) in Combination With Paclitaxel in Subjects With Advanced or Metastatic Breast Cancer

    This is a standard Phase 1b and 2a, multi-center, study design that will examine the safety, tolerability, maximum tolerated dose, and overall response rate of tivozanib (AV-951) and paclitaxel in a breast cancer.
    Phase: Phase 1/Phase 2
    Diagnosis: Breast Cancer

  29. Phase I/II Study of MK-0752 Followed by Docetaxel in Advanced or Metastatic Breast Cancer

    New and better therapies for locally advanced and metastatic breast cancer are needed because, even if standard treatment is successful in shrinking the cancer, there is still a high chance that the cancer will recur. Recent research suggests that breast tumors have a small number of cells in them that are "breast cancer stem cells", which are very resistant to standard treatment. It is thought that the reason that many patients cannot be cured of their breast cancers is that the stem cells are unable to be killed and remain in the body after standard treatment. Laboratory research has shown that a new drug, MK-0752, can target stem cells and prevent tumor recurrences when the drug is combined with docetaxel, a chemotherapy drug commonly used to treat breast cancer. We know that MK-0752 is safe when given by itself to people. We do not know if treatment with MK-0752 and docetaxel combined is safe or if it will kill "breast cancer stem cells" in people with breast cancer. This clinical trial is being done to determine the safety of several doses of MK-0752 in combination with docetaxel. Preliminary data about the effectiveness of MK-0752 in combination with docetaxel will be collected. Also, tumor biopsy samples will be taken from some patients who have tumors that can be easily biopsied. The samples will be used to perform research tests to help determine if the "breast cancer stem cells" are being killed by the drug combination.
    Phase: Phase 1/Phase 2
    Diagnosis: Breast Cancer

  30. Lapatinib in Treating Women With Ductal Carcinoma In Situ of the Breast

    RATIONALE: Lapatinib may stop the growth of ductal carcinoma in situ cells by blocking some of the enzymes needed for cell growth. PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of lapatinib and to see how well it works in treating women with ductal carcinoma in situ of the breast.
    Phase: Phase 1/Phase 2
    Diagnosis: Breast Cancer