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    Breast Cancer Clinical Trials

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    Further protocol information can be found on the links below at ClinicalTrials.gov


    Active Trials

    Title: A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases
    Description: This phase I trial studies the side effects and the best dose of stereotactic body radiation therapy in treating patients with breast cancer that has spread to other parts of the body
    Investigator: NCI - National Cancer Institute
    Eligibility: MALE and FEMALE subjects, 18 y/o and older, with metastatic breast cancer (MBC)
    Status: Please contact site for study status
    Contact: Madeline Decker, 415-600-3613, Email: DeckerM@cpmcri.org about Study NRG-BR001

    Title: A Multicenter, Multinational, Phase II Study to Evaluate Pertuzumab in Combination With Trastuzumab and Standard Neoadjuvant Anthracycline-based Chemotherapy in Patients With HER2-Positive, Locally Advanced, Inflammatory, or Early-Stage Breast Cancer
    Description: This study study is designed to evaluate the safety and efficacy of Perjeta in combination with Herceptin and anthra cycline-based chemotherapy as neoadjuvant treatment in patients with HER2-based locally advanced, inflammatory, or early-stage breast cancer
    Investigator: Wei Wang, MD
    Eligibility: MALE and FEMALE subjects, 18 y/o and older, with locally advanced, inflammatory, or early-stage, unilateral, and histologically confirmed invasive breast cancer. Patients with inflammatory breast cancer must be able to have a core needle biopsy
    Status: Active and open to enrollment
    Contact: Madeline Decker, 415-600-3613, Email: DeckerM@cpmcri.org about Study Genentech WO29217

    Title: Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients With High-Risk, Hormone Receptor-Positive and HER2/Neu Negative Breast Cancer
    Description: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer
    Investigator: NCI - National Cancer Institute
    Eligibility: MALE and FEMALE subjects, 18 y/o and older, who have a histologically confirmed diagnosis of invasive breast carcinoma with positive estrogen (ER)- and/or progesterone-receptor (PR) status, and negative human epidermal growth factor receptor (HER)2, for whom standard adjuvant endocrine therapy is planned
    Status: Please contact site for study status
    Contact: Madeline Decker, 415-600-3613, Email: DeckerM@cpmcri.org about Study SWOG S1207

    Title: A Randomized, Double-blind, Parallel Group, Placebo-controlled Multi-centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients With Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy
    Description: Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy
    Investigator: NCI - National Cancer Institute
    Eligibility: MALE and FEMALE subjects, 18 years and older, who have a histologically confirmed non-metastatic primary triple negative invasive adenocarcinoma of the breast.
    Status: Please contact site for study status
    Contact: Madeline Decker, 415-600-3613, Email: DeckerM@cpmcri.org about Study NSABP B-55

    Title: Phase II Randomized Study of Whole Brain Radiotherapy in Combination With Concurrent Lapatinib in Patients With Brain Metastasis From HER2-Positive Breast Cancer: A Collaborative Study of NRG Oncology and KROG
    Description: This randomized phase II trial studies how well whole-brain radiation therapy (WBRT) 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
    Investigator: NCI - National Cancer Institute
    Eligibility: MALE and FEMALE Subjects, 18 y/o and older, with pathologically (histologically or cytologically) proven diagnosis of invasive breast cancer
    Status: Please contact site for study status
    Contact: Madeline Decker, 415-600-3613, Email: DeckerM@cpmcri.org about Study RTOG 1119

    Title: A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy
    Description: This randomized phase III trial studies axillary lymph node dissection to see how well it works compared to axillary radiation therapy in treating patients with node-positive breast cancer treated with neoadjuvant chemotherapy followed by surgery
    Investigator: NCI - National Cancer Institute
    Eligibility: MALE and FEMALE subjects, 18 y/o and older, with a clinical stage T1-3 N1 M0 breast cancer at diagnosis (prior to the start of neoadjuvant chemotherapy) by American Joint Committee on Cancer (AJCC) staging 7th edition
    Status: Please contact site for study status
    Contact: Madeline Decker, 415-600-3613, Email: DeckerM@cpmcri.org about Study A011202

    A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients With 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer With Recurrence Score (RS) of 25 or Less
    Description: RxPONDER: A Clinical Trial Rx for Positive Node, Endocrine Responsive Breast Cancer
    Investigator: NCI - National Cancer Institute
    Eligibility: FEMALE subjects, 18 y/o and older, who have a histologically confirmed diagnosis of node positive (1-3 nodes) invasive breast carcinoma with positive estrogen and/or progesterone receptor status, and negative HER-2 status; estrogen and progesterone receptor positivity
    Status: Please contact site for study status
    Contact: Madeline Decker, 415-600-3613, Email: DeckerM@cpmcri.org about Study SWOG S1007

    Title: A Randomized Placebo-Controlled Phase III Study of Duloxetine for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Women With Early Stage Breast Cancer
    Description: This randomized phase III trial studies how well duloxetine hydrochloride works compared to a placebo in treating muscle, bone, and joint pain in patients with early-stage breast cancer receiving hormone therapy
    Investigator: NCI - National Cancer Institute
    Eligibility: FEMALE subjects, 18 y/o and older, who have histologically confirmed estrogen receptor (ER)- and/or progesterone receptor (PgR)-positive invasive carcinoma of the breast with no evidence of metastatic disease (M0)
    Status: Please contact site for study status
    Contact: Madeline Decker, 415-600-3613, Email: DeckerM@cpmcri.org about Study SWOG S1202

    Title: A Randomized Phase 3 Clinical Trial Evaluating Post-Mastectomy Chestwall & Regional Nodal XRT & Post-Lumpectomy Regional Nodal XRT in Patients With Positive Axillary Nodes Before Neoadjuvant Chemo Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemo
    Description: Standard or Comprehensive Radiation Therapy in Treating Patients With Early-Stage Breast Cancer Previously Treated With Chemotherapy and Surgery
    Investigator: NCI - National Cancer Institute
    Eligibility: FEMALE subjects, 18 y/o and older, who have clinically T1-3, N1 breast cancer at the time of diagnosis (before neoadjuvant therapy) and who have had pathologic confirmation of axillary nodal involvement at presentation (before neoadjuvant therapy)
    Status: Please contact site for study status
    Contact: Madeline Decker, 415-600-3613, Email: DeckerM@cpmcri.org about Study NSABP B-51

    Title: A Randomized Phase III Trial Evaluating Pathologic Complete Response Rates in Patients With Hormone Receptor-Positive, HER2-Positive, Large Operable and Locally Advanced Breast Cancer Treated With Neoadjuvant Therapy of Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab (TCHP) With or Without Estrogen Deprivation
    Description: This randomized phase III trial studies docetaxel, carboplatin, trastuzumab, and pertuzumab with estrogen deprivation to see how they work compared to docetaxel, carboplatin, trastuzumab, and pertuzumab without estrogen deprivation in treating patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-positive, operable or locally advanced breast cancer
    Investigator: NCI - National Cancer Institute
    Eligibility: FEMALE subjects, 18 y/o and older, with a diagnosis of breast cancer
    Status: Please contact site for study status
    Contact: Madeline Decker, 415-600-3613, Email: DeckerM@cpmcri.org about Study NSABP B-52

    Title: Randomized Double-Blind Placebo Controlled Study of Subcutaneous Testosterone in the Adjuvant Treatment of Postmenopausal Women With Aromatase Inhibitor Induced Arthralgias
    Description: Testosterone in Treating Postmenopausal Patients With Arthralgia Caused by Adjuvant Aromatase Inhibitor Treatment
    Investigator: NCI - National Cancer Institute
    Eligibility: FEMALE subjects, 18 y/o and older, who have undergone a total mastectomy or breast-conserving surgery for primary breast cancer +/-chemotherapy and +/-radiotherapy
    Status: Please contact site for study status
    Contact: Madeline Decker, 415-600-3613, Email: DeckerM@cpmcri.org about Study Alliance A221102

    Title: A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-Negative Breast Cancer
    Description: This is a randomized, double-blind, placebo controlled clinical trial comparing the overall survival of women with advanced or metastatic HER2-negative breast cancer who receive treatment with capecitabine in combination with ruxolitinib versus those who receive treatment with capecitabine alone
    Investigator: Ari Baron, MD
    Eligibility: FEMALE subjects, 18 y/o and older, who have a histologically or cytologically confirmed HER2-negative adenocarcinoma of the breast
    Status: Active and open to enrollment
    Contact: Madeline Decker, 415-600-3613, Email: DeckerM@cpmcri.org about Study Incyte 268

    Title: A Phase II, Single Arm Study of the Use of Steroid-based Mouthwash to Prevent Stomatitis in Postmenopausal Women With Advanced or Metastatic Hormone Receptor Positive Breast Cancer Being Treated With Everolimus Plus Exemestane
    Description: Open-label, Phase II study of Stomatitis prevention with a steroid-based mouthwash in Post-menopausal women with ER+, HER2- Metastatic or Locally Advanced Breast Cancer
    Investigator: Wei Wang, MD
    Eligibility: FEMALE subjects, 18 y/o and older, who have metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy
    Status: Active and open to enrollment
    Contact: Madeline Decker, 415-600-3613, Email: DeckerM@cpmcri.org about Study Novartis STOPP

    Title: Alternate Approaches for Clinical Stage II or III Estrogen Receptor Positive Breast Cancer Neoadjuvant Treatment (ALTERNATE) in Postmenopausal Women: A Phase III Study
    Description: Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery
    Investigator: NCI - National Cancer Institute
    Eligibility: FEMALE subjects, 18 y/o and older, with a diagnosis of breast cancer
    Status: Please contact site for study status
    Contact: Madeline Decker, 415-600-3613, Email: DeckerM@cpmcri.org about Study Alliance A011106

    Title: A Phase II Randomized, Double-blind Placebo Controlled, Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women With Hormone Receptor-positive HER2-negative Breast Cancer
    Description: This study is to determine whether treatment with a PI3K inhibitor plus letrozole leads to an increase in pathologic response compared to treatment with placebo plus letrozole in patients with Breast cancer
    Investigator (Santa Rosa): Eric Dean, MD
    Eligibility: Postmenopausal women, 18 y/o and older, with a histologically and/or cytologically confirmed diagnosis of breast cancer
    Status: Active and open to enrollment
    Contact (Santa Rosa): Christina DeVisser, 707-576-4739, Email: DevissC@cpmcri.org about Study Novartis CBYL719A2201

    • updated July 2015

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