Treatment Clinical Trials for Breast Cancer

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Clinical trials are research studies that involve people. The clinical trials on this list are for breast cancer treatment. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-25 of 445
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  • Hormone Therapy with or without Everolimus in Treating Patients with Breast Cancer

    This randomized phase III trial studies how well hormone therapy when given together with or without everolimus work in treating patients with breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether hormone therapy is more effective when given with or without everolimus in treating breast cancer.
    Location: 1375 locations

  • Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel with or without Carboplatin in Treating Patients with Triple-Negative Breast Cancer

    This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.
    Location: 1194 locations

  • Weight Loss Interventions in Treating Overweight and Obese Women with a Higher Risk for Breast Cancer Recurrence

    This randomized phase III trial studies weight loss interventions in treating overweight and obese women with a higher risk for breast cancer that comes back (recurrence). Many studies have shown that women who are overweight or obese when diagnosed with breast cancer appear to have a higher risk of cancer recurrence. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the program.
    Location: 1140 locations

  • NCI-MATCH: Targeted Therapy Directed by Genetic Testing in Treating Patients with Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma

    This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.
    Location: 1172 locations

  • Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane with or without Chemotherapy in Treating Patients with Invasive RxPONDER Breast Cancer

    This randomized phase III clinical trial studies how well tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy work in treating patients with breast cancer that has spread from where it began in the breast to surrounding normal tissue (invasive). Estrogen can cause the growth of breast cancer cells. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight breast cancer 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, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving tamoxifen citrate, anastrozole, letrozole, or exemestane is more effective with combination chemotherapy in treating patients with breast cancer.
    Location: 1414 locations

  • Aspirin in Preventing Recurrence of Cancer in Patients with Node Positive or High Risk Node Negative, HER2 Negative Stage II-III Breast Cancer after Chemotherapy, Surgery, and / or Radiation Therapy

    This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with node positive or high risk node negative, human epidermal growth factor receptor 2 (HER2) negative breast cancer after chemotherapy, surgery, and / or radiation therapy. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast cancer.
    Location: 1045 locations

  • Lymph Node Dissection and Radiation Therapy in Treating Patients with Breast Cancer Previously Treated with Chemotherapy and Surgery

    This randomized phase III trial studies lymph node dissection and radiation therapy to see how well it works compared to radiation therapy alone in treating patients with breast cancer previously treated with chemotherapy and surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known if radiation therapy works better alone or with lymph node dissection in treating patients with breast cancer previously treated with chemotherapy and surgery.
    Location: 1023 locations

  • Platinum Based Chemotherapy or Capecitabine in Treating Patients with Residual Triple-Negative Basal-Like Breast Cancer following Neoadjuvant Chemotherapy

    This randomized phase III trial studies how well cisplatin or carboplatin (platinum based chemotherapy) works compared to capecitabine in treating patients with remaining (residual) basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant). Drugs used in chemotherapy, such as cisplatin, carboplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether cisplatin or carboplatin is more effective than capecitabine in treating patients with residual triple negative basal-like breast cancer.
    Location: 837 locations

  • Cisplatin with or without Veliparib in Treating Patients with Stage IV Triple-Negative and / or BRCA Mutation-Associated Breast Cancer

    This randomized phase II trial studies how well cisplatin works with or without veliparib in treating patients with stage IV triple-negative breast cancer and / or breast cancer (BRCA) mutation-associated breast cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if cisplatin is more effective with or without veliparib in treating patients with triple-negative and / or BRCA mutation-associated breast cancer.
    Location: 725 locations

  • Fulvestrant and / or Anastrozole in Treating Postmenopausal Patients with Stage II-III Breast Cancer Undergoing Surgery

    This randomized phase III trial studies fulvestrant to see how well it works compared to anastrozole or fulvestrant and anastrozole in treating postmenopausal patients with stage II-III breast cancer undergoing surgery. Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant and anastrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. It is not yet known whether giving fulvestrant alone, anastrozole alone, or fulvestrant and anastrozole together is more effective in treating patients with breast cancer.
    Location: 762 locations

  • Exemestane with or without Entinostat in Treating Patients with Recurrent Hormone Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic

    This randomized phase III trial studies exemestane and entinostat to see how well they work compared to exemestane alone in treating patients with hormone receptor-positive breast cancer that has spread to nearby tissue or lymph nodes or another place in the body. Estrogen can cause the growth of breast cancer cells. Endocrine therapy using exemestane may fight breast cancer by lowering the amount of estrogen the body makes. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether exemestane is more effective with or without entinostat in treating breast cancer.
    Location: 635 locations

  • Standard or Comprehensive Radiation Therapy in Treating Patients with Early-Stage Breast Cancer Previously Treated with Chemotherapy and Surgery

    This randomized phase III trial studies radiation therapy to the breast, chest wall and lymph nodes (comprehensive) compared to standard radiation therapy to the breast in treating patients with early-stage breast cancer previously treated with chemotherapy and surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with early-stage breast cancer.
    Location: 529 locations

  • Pembrolizumab in Treating Patients with Triple-Negative Breast Cancer

    This randomized phase III trial studies how well pembrolizumab works in treating triple-negative breast cancer. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.
    Location: 400 locations

  • Olaparib in Treating Patients with Triple-Negative Non-metastatic Breast Cancer Who Have Completed Definitive Local Treatment and Chemotherapy

    This randomized phase III trial studies how well olaparib works in treating patients with triple-negative breast cancer that has not spread to another place in the body who have completed definitive local treatment and chemotherapy. Olaparib may stop the growth of tumor cells by blocking specific enzymes needed for the maintenance of deoxyribonucleic acid (DNA) repair. Olaparib may also enhance the DNA damaging effects of chemotherapy.
    Location: 417 locations

  • Whole-Brain Radiation Therapy or Stereotactic Radiosurgery with or without Lapatinib Ditosylate in Treating Patients with Brain Metastasis from HER2-Positive Breast Cancer

    This randomized phase II trial studies how well whole-brain radiation therapy or stereotactic radiosurgery with or without lapatinib ditosylate works in treating patients with breast cancer that has too many of a protein called human epidermal growth factor receptor 2 (HER2) on its cells and has spread to the brain. Radiation therapy uses high energy x rays to kill tumor cells and shrink tumors. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether whole-brain radiation therapy or stereotactic radiosurgery together with lapatinib ditosylate is an effective treatment for brain metastasis from breast cancer.
    Location: 267 locations

  • Standard of Care Therapy with or without Stereotactic Radiosurgery and / or Surgery in Treating Patients with Limited Metastatic Breast Cancer

    This randomized phase II / III trial studies how well standard of care therapy with stereotactic radiosurgery and / or surgery works and compares it to standard of care therapy alone in treating patients with breast cancer that has spread to one or two locations in the body (limited metastatic) that are previously untreated. Standard of care therapy comprising chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of tumor cells. Radiation therapy and / or surgery is usually only given with standard of care therapy to relieve pain; however, in patients with limited metastatic breast cancer, stereotactic radiosurgery, also known as stereotactic body radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue and surgery may be able to effectively remove the metastatic tumor cells. It is not yet known whether standard of care therapy is more effective with stereotactic radiosurgery and / or surgery in treating limited metastatic breast cancer.
    Location: 91 locations

  • Stereotactic Body Radiation Therapy in Treating Patients with Metastatic Breast Cancer, Non-small Cell Lung Cancer, or Prostate Cancer

    This phase I trial studies the side effects and the best dose of stereotactic body radiation therapy in treating patients with breast cancer, non-small cell lung cancer, or prostate cancer that has spread to other parts of the body. Stereotactic body radiation therapy delivers fewer, tightly-focused, high doses of radiation therapy to all known sites of cancer in the body while minimizing radiation exposure of surrounding normal tissue.
    Location: 70 locations

  • Eribulin Mesylate or Paclitaxel as First- or Second-Line Therapy in Treating Patients with Recurrent Stage IIIC-IV Breast Cancer

    This randomized phase III trial studies how well eribulin mesylate or paclitaxel work as first- or second-line therapy in treating patients with stage IIIC-IV breast cancer that has come back. Drugs used in chemotherapy, such as eribulin mesylate and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
    Location: 36 locations

  • Veliparib and Atezolizumab Either Alone or in Combination in Treating Patients with Stage III-IV Triple Negative Breast Cancer

    This randomized phase II trial studies how well veliparib and atezolizumab work either alone or in combination in treating patients with stage III-IV triple negative breast cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. It is not known whether giving veliparib and atezolizumab either alone or in combination would work better in patients with triple negative breast cancer.
    Location: 33 locations

  • PALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+) / Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Early Breast Cancer

    This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer (EBC). The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+ / HER2- early breast cancer. Assessment of a variety of correlative analysis, including evaluation of the effect of palbociclib in genomically defined tumor subgroups, is planned.
    Location: 33 locations

  • Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1 / 2 / 3 (Trk A / B / C), ROS1, or ALK Gene Rearrangements (Fusions)

    This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1 / 2 / 3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.
    Location: 25 locations

  • Cisplatin or Paclitaxel before Surgery in Treating Patients with Triple Negative Stage I-III Breast Cancer

    This randomized phase II trial studies how well cisplatin or paclitaxel before surgery works in treating patients with triple negative stage I-III breast cancer. Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or stopping them from spreading.
    Location: 21 locations

  • Cisplatin or Doxorubicin Hydrochloride and Cyclophosphamide before Surgery in Treating Patients with Newly Diagnosed Breast Cancer and BRCA Mutations

    This randomized phase II trial studies how well cisplatin or doxorubicin hydrochloride and cyclophosphamide before surgery work in treating patients with newly diagnosed breast cancer with an inherited mutation (a change in the deoxyribonucleic acid [DNA] sequence of a cell) in the breast cancer early onset 1 (BRCA1) or BRCA2 gene. Drugs used in chemotherapy, such as cisplatin, doxorubicin hydrochloride, and cyclophosphamide work in different way to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether cisplatin is more effective than doxorubicin hydrochloride and cyclophosphamide when given before surgery in treating patients with breast cancer.
    Location: 21 locations

  • Phase 1 / 1b Study to Evaluate the Safety and Tolerability of CPI-444 Alone and in Combination With Atezolizumab in Advanced Cancers

    This is a phase 1 / 1b open-label, multicenter, dose-selection study of CPI-444, an oral small molecule targeting the adenosine-A2A receptor on T-lymphocytes and other cells of the immune system. This trial will study the safety, tolerability, and anti-tumor activity of CPI-444 as a single agent and in combination with atezolizumab, a PD-L1 inhibitor against various solid tumors. CPI-444 blocks adenosine from binding to the A2A receptor. Adenosine suppresses the anti-tumor activity of T cells and other immune cells.
    Location: 21 locations

  • Phase 2 Study of Tucatinib vs Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer

    The purpose of this study is to assess the effect of tucatinib vs. placebo in combination with capecitabine and trastuzumab on progression-free survival (PFS) per RECIST 1.1 based on independent central review.
    Location: 19 locations


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