Clinical Trials Using Fulvestrant

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Clinical trials are research studies that involve people. The clinical trials on this list are studying Fulvestrant. 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 37
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  • 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: 677 locations

  • Neratinib with or without Fulvestrant in Metastatic HER2-Negative but HER2 Mutant Breast Cancer

    This phase II trial studies how well neratinib with or without fulvestrant works in treating patients with human epidermal growth factor receptor 2 (HER2)-negative breast cancer that carries HER2 gene mutations and has spread to other parts of the body (metastatic). Neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving neratinib with fulvestrant may provide a more effective treatment for patients with this type of breast cancer.
    Location: 13 locations

  • Palbociclib in Combination with Fulvestrant or Tamoxifen Citrate in Treating Patients with Locally Advanced or Metastatic Hormone Receptor Positive Breast Cancer

    This phase II trial studies the side effects of palbociclib when given together with fulvestrant or tamoxifen citrate in treating patients with hormone receptor positive breast cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy using fulvestrant or tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving palbociclib together with fulvestrant or tamoxifen citrate may work better in treating hormone receptor positive breast cancer.
    Location: 11 locations

  • An Open-label, Phase 2 Study of Neratinib in Patients With Solid Tumors With Somatic Human Epidermal Growth Factor Receptor (EGFR, HER2, HER3) Mutations or EGFR Gene Amplification

    This is an open-label, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification.
    Location: 9 locations

  • A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Participants With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma (NHL) and in Combination With Endocrine Therapy in Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer

    This is an open-label, multicenter, Phase I / II study to assess the safety, tolerability, and pharmacokinetics of GDC-0032. The Phase I portion will be divided into two stages. During Stage 1, GDC-0032 will be administered every day orally and at escalating doses in participants with locally advanced or metastatic solid tumors. During Stage 2, GDC-0032 will be administered alone or as combination therapy within indication-specific cohorts. In Phase II of the study, the efficacy and safety of the combination GDC-0032 and fulvestrant will be evaluated in post-menopausal female participants with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative, hormone receptor-positive breast cancer.
    Location: 9 locations

  • A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib / Letrozole Or Palbociclib / Fulvestrant In Women With Metastatic Breast Cancer

    This is a multicenter, open label, Phase 1b study in patients with mBC. This study will have a dose escalation to identify the maximum tolerated dose (MTD) of the combination of gedatolisib plus palbociclib / fulvestrant and gedatolisib plus palbociclib / letrozole and expansion to estimate the objective response rate (OR) of the combination of gedatolisib plus palbociclib / letrozole or palbociclib / fulvestrant.
    Location: 10 locations

  • A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer

    The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant or chemotherapy in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 positive (HER2+) locally advanced or metastatic breast cancer after prior exposure to at least two HER2-directed therapies for advanced disease.
    Location: 8 locations

  • Safety and Efficacy Study of MLN0128 in Combination With Exemestane or Fulvestrant in Postmenopausal Women With ER / PR+ Metastatic Breast Cancer

    This is a phase 1b / 2 study of the safety and efficacy of MLN0128 in combination with exemestane or fulvestrant therapy in women with estrogen receptor positive / human epidermal growth factor receptor 2 negative (ER+ / HER2-) advanced or metastatic breast cancer that has progressed on treatment with everolimus in combination with exemestane or fulvestrant.
    Location: 8 locations

  • Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer

    The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.
    Location: 10 locations

  • Fulvestrant with or without Ribociclib in Patients with Recurrent, Unresectable, or Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer

    This randomized, phase II trial studies how well fulvestrant with or without ribociclib works in treating patients with hormone receptor positive, human epidermal growth factor receptor 2 (HER2) negative breast cancer that has progressed after treatment with an aromatase inhibitor or cyclin-dependent kinase 4 / 6 inhibitor, cannot be removed by surgery, or has spread to other parts of the body. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells or reducing the amount of estrogen made by the body. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving fulvestrant with or without ribociclib may be an effective treatment for patients with breast cancer.
    Location: 11 locations

  • To Evaluate the Safety, Tolerability, and Pharmacokinetics of GDC-0077 Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer

    This is an open-label, multicenter, Phase I study designed to evaluate the safety, tolerability, and pharmacokinetics of GDC-0077 administered orally as a single agent in participants with locally advanced or metastatic Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Alpha (PIK3CA)-mutant solid tumors, including breast cancer, and in combination with standard-of-care endocrine and targeted therapies for the treatment of locally advanced or metastatic PIK3CA-mutant hormone receptor-positive (HR+) / human epidermal growth factor receptor 2 negative (HER2-) breast cancer. Participants will be enrolled in two stages: a dose-escalation stage (Stage I) and an expansion stage (Stage II). Participants will be assigned to one of four regimens: GDC-0077 as a single agent (Arm A), GDC-0077 in combination with palbociclib and letrozole (Arm B), GDC-0077 in combination with letrozole (Arm C), or GDC-0077 in combination with fulvestrant (Arm D).
    Location: 5 locations

  • MLN0128 in Combination With Fulvestrant in Women With Advanced or Metastatic Breast Cancer After Aromatase Inhibitor Therapy

    The primary purpose of this study is to compare the progression free survival (PFS) of participants treated with the combination of fulvestrant plus daily MLN0128 and fulvestrant plus weekly MLN0128 versus participants treated with single-agent fulvestrant.
    Location: 6 locations

  • Dose Escalation and Expansion Study of GSK525762 in Combination With Fulvestrant in Subjects With Estrogen Receptor Positive (ER+) Breast Cancer

    This is a combination Phase I and Phase II study, with an aim to evaluate the combination of GSK525762 and fulvestrant in women with advanced or metastatic ER+ breast cancer, who have disease that has progressed after prior treatment with at least one line of endocrine therapy. The objectives of the study are to first identify, in open-label single-arm Phase I, a recommended Phase II dose of GSK525762 that may be combined safely with fulvestrant. Phase I will follow a modified toxicity probability interval (mTPI) design, and a sentinel group will be evaluated first for dose-limiting toxicity and further expanded to collect additional safety data. This will be followed by a double-blind, randomized controlled Phase II, to identify the clinical activity of the two study treatments when given in combination. The composition of Phase II will be selected at the end of Phase I. Approximately, up to 140 subjects and 154 subjects will receive study treatment in Phase I and Phase II respectively. A completed subject will be one who is followed until death.
    Location: 4 locations

  • Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.

    To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who received prior treatment with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease.
    Location: 5 locations

  • Taselisib and Anti-HER2 Therapy in Treating Patients with Advanced HER2+ Breast Cancer

    This phase Ib trial studies the side effects and best dose of taselisib when given with anti-human epidermal growth factor receptor 2 (HER2) therapies in treating patients with HER2 positive (HER2+) breast cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Taselisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab emtansine, pertuzumab, and trastuzumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as 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. Estrogen can cause the growth of breast cancer cells. Antihormone therapy, such as fulvestrant, may lessen the amount of estrogen made by the body. It is not yet known whether taselisib works better when given together with trastuzumab emtansine, pertuzumab, and trastuzumab, or with pertuzumab, trastuzumab, paclitaxel, and fulvestrant in treating patients with breast cancer.
    Location: 5 locations

  • Fulvestrant with or without Ganetespib in Treating Patients with Hormone-Receptor Positive, Advanced or Metastatic Breast Cancer That Cannot Be Removed by Surgery

    This phase II trial studies how well fulvestrant works with or without ganetespib in treating patients with hormone-receptor positive breast cancer that has spread to other places in the body and cannot be removed by surgery. Ganetespib is a drug that may stop cancer cells from growing. Ganetespib is considered a “heat shock protein 90 (HSP90) inhibitor”. By blocking HSP90, ganetespib is thought to reduce the ability of cancer cells to become resistant to treatment. Fulvestrant may bind to estrogen receptors in breast cancer cells, resulting in estrogen receptor deformation and decreased estrogen binding. This may inhibit the growth of hormone-resistant, estrogen-sensitive, human breast cancer cell lines. It is not yet known whether fulvestrant works better with or without ganetespib in treating patients with hormone-receptor positive breast cancer that has spread to other places in the body and cannot be removed by surgery.
    Location: 4 locations

  • Fulvestrant with or without Palbociclib and Avelumab in Treating Patients with Hormone Receptor Positive, HER2 Negative Metastatic or Recurrent Breast Cancer That Cannot Be Removed by Surgery Previously Treated with CDK and Endocrine Therapy

    This randomized pilot phase II trial studies how well fulvestrant with or without palbociclib and avelumab works in treating patients with hormone receptor positive, HER2 negative breast cancer that has spread to other parts of the body or that has come back after a period of improvement and cannot be removed by surgery, and have been previously treated with CDK and endocrine therapy. Endocrine therapy with fulvestrant prevents growth of hormone receptor positive breast cancer by blocking stimulation of tumor cells by estrogen. Palbociclib is a drug that may stop tumor cells from growing by blocking activity of two closely related enzymes (proteins that help chemical reactions in the body occur), called cyclin dependent kinases 4 and 6 (CDK 4 / 6) which are known to promote tumor cell growth. Monoclonal antibodies, such as avelumab, may help the immune system in detecting and fighting tumor cells. Giving fulvestrant with or without palbociclib and avelumab may work better in treating patients with breast cancer.
    Location: 2 locations

  • Efficacy and Safety of Treatment With Alpelisib Plus Endocrine Therapy in Patients With HR+, HER2-negative aBC, With PIK3CA Mutations, Whose Disease Has Progressed on or After CDK 4 / 6 Treatment With an Aromatase Inhibitor (AI) or Fulvestrant

    Efficacy and safety of treatment with alpelisib plus endocrine therapy in patients with HR+, HER2-negative aBC, with PIK3CA mutations, whose disease has progressed on or after CDK 4 / 6 treatment with an aromatase inhibitor (AI) or fulvestrant
    Location: 3 locations

  • Alternative Dosing Schedule of Palbociclib and Letrozole or Fulvestrant with or without Goserelin Acetate in Treating Patients with Metastatic Hormone Receptor Positive Breast Cancer

    This phase II trial studies the side effects of an alternative dosing schedule of palbociclib and letrozole or fulvestrant with or without goserelin acetate in treating patients with hormone receptor positive breast cancer that has spread to other places in the body. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen and progesterone can cause the growth of breast tumor cells. Hormone therapy using letrozole, fulvestrant, and goserelin acetate may fight hormone receptor positive breast cancer by blocking the use of estrogen and progesterone by the tumor cells. Giving an alternative dosing schedule of palbociclib and letrozole or fulvestrant with or without goserelin acetate may work better in treating patients with hormone receptor positive breast cancer.
    Location: 2 locations

  • GS-5829 in Combination With Fulvestrant or Exemestane in Women With Advanced Estrogen Receptor Positive, HER2 Negative-Breast Cancer

    The primary objectives of the Phase 1b Dose Escalation part of this study are to characterize the safety and tolerability of GS-5829 in combination with exemestane or fulvestrant in women with advanced estrogen receptor positive Her2-negative (ER+ / HER2-) breast cancer and to determine the maximum tolerated dose (MTD) (if not already determined) or the recommended dose for the Phase 2 part of this study. The primary objectives of the Randomized Phase 2 Dose Expansion portion of this study are to evaluate the efficacy of GS-5829 in combination with fulvestrant compared to fulvestrant alone in women with advanced ER+ / HER2- breast cancer.
    Location: 4 locations

  • A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread

    The main purpose of this study is to evaluate the safety of a study drug known as LY2835219 in combination with different therapies (letrozole, anastrozole, tamoxifen, exemestane, exemestane plus everolimus, trastuzumab, or LY3023414 plus fulvestrant) for breast cancer that has spread to other parts of the body.
    Location: 2 locations

  • AKT Inhibitor AZD5363 with or without Enzalutamide or Fulvestrant in Treating Patients with Advanced, Metastatic, or Recurrent Solid Tumors with AKT1, AKT2, or AKT3 Mutations

    This pilot phase I trial studies how well AKT inhibitor AZD5363 with or without enzalutamide or fulvestrant work in treating patients with solid tumors with AKT1, AKT2, or AKT3 mutations that have spread to other places in the body or have come back. AKT inhibitor AZD5363 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Prostate specific antigen or estrogen can cause the growth of tumor cells. Hormone therapy using enzalutamide or fulvestrant may fight prostate or breast cancer by blocking the use of prostate specific antigen or estrogen by the tumor cells. AKT inhibitor AZD5363 with or without enzalutamide or fulvestrant may work better in treating patients with solid tumor with AKT1, AKT2, or AKT3 mutations.
    Location: Memorial Sloan-Kettering Cancer Center, New York, New York

  • Fulvestrant, Palbociclib, and pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Treating Patients with Estrogen Receptor Positive, HER2 Negative, and FGFR Amplified Stage IV Breast Cancer That Is Recurrent or Cannot Be Removed by Surgery

    This phase Ib trial studies the side effects and best dose of pan-FGFR tyrosine kinase inhibitor JNJ-42756493 when given together with fulvestrant and palbociclib in treating patients with estrogen receptor positive, HER2 negative, and FGFR amplified stage IV breast cancer that has come back or cannot be removed by surgery. Drugs used in chemotherapy, such as fulvestrant, 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. Palbociclib and pan-FGFR tyrosine kinase inhibitor JNJ-42756493 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving fulvestrant, palbociclib, and pan-FGFR tyrosine kinase inhibitor JNJ-42756493 may work better in treating patients with breast cancer.
    Location: 4 locations

  • This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer.

    For each dose finding cohorts (A, B, C and D): The primary objective of each dose finding cohort is to determine the maximum tolerated dose (MTD) / recommended phase II dose (RP2D) of xentuzumab in combination with abemaciclib with or without hormonal therapy (letrozole, anastrozole, fulvestrant). Dose limiting toxicities (DLT) will be assessed during the first treatment cycle to assess the MTD / RP2D. In case that no MTD is reached a RP2D dose will be determined taking into account safety data and other available information. This will be agreed with the Steering Committee. For each expansion cohorts (E and F): The objectives of the expansion cohorts are to assess the anti-tumour activity of xentuzumab in combination with abemaciclib in patients with non-small cell lung cancer (cohort E). Tentatively a cohort F may be opened to assess the anti-tumour activity of the triplet combination xentuzumab / abemaciclib and fulvestrant in a single-arm expansion group of patients with locally advanced / metastatic hormone receptor positive (HR+) breast cancer who have progressed following prior aromatase inhibitor therapy and prior CDK4 / 6 inhibitor treatment. Cohort F will only be opened if indicated by emerging data from ongoing clinical trials.
    Location: University of Minnesota / Masonic Cancer Center, Minneapolis, Minnesota

  • Fulvestrant with or without Enzalutamide in Treating Patients with Estrogen Receptor Positive and HER2 Negative Breast Cancer

    This randomized phase II trial studies how well fulvestrant with or without enzalutamide works in treating patients with estrogen receptor positive and HER2 negative breast cancer. Drugs used in chemotherapy, such as fulvestrant, 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. Androgen can cause the growth of breast cancer cells. Hormone therapy using enzalutamide may fight breast cancer by blocking the use of androgen by the tumor cells. Giving fulvestrant and enzalutamide may work better in treating patients with breast cancer.
    Location: 3 locations


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