Clinical Trials Using Fulvestrant

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 45
1 2 Next >

  • Palbociclib and Letrozole or Fulvestrant in Treating Patients Aged 70 and Older with Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer

    This phase II trial studies the side effects and how well palbociclib and letrozole or fulvestrant works in treating patients aged 70 and older with estrogen receptor positive, HER2 negative breast cancer that 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. Drugs used in chemotherapy, such as letrozole or 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. It is not yet known if giving palbociclib and letrozole or fulvestrant may work better in treating patients aged 70 and older with breast cancer.
    Location: 410 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: 29 locations

  • Neratinib HER Mutation Basket Study (SUMMIT)

    This is an open-label, non-randomized, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in patients with ERBB mutation-positive or EGFR gene-amplified solid tumors.
    Location: 25 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: 22 locations

  • Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutation With Advanced Breast Cancer Who Have Progressed on or After Prior Treatments

    Study assessing the efficacy and safety of alpelisib plus fulvestrant or letrozole, based on prior endocrine therapy, in patients with PIK3CA mutation with advanced breast cancer who have progressed on or after prior treatments
    Location: 15 locations

  • Fulvestrant or Exemestane 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 or exemestane 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 (recurrent), cannot be removed by surgery (unresectable), or has spread to other parts of the body (metastatic). Hormone therapy using fulvestrant or exemestane 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 or exemestane with ribociclib may be an effective treatment for patients with breast cancer.
    Location: 12 locations

  • Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+ / HER2- Advanced Breast Cancer

    This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at least one endocrine therapy including a CDK4 / 6 inhibitor in combination with fulvestrant or an aromatase inhibitor (AI) .
    Location: 13 locations

  • A Phase II Study Comparing The Efficacy Of Venetoclax + Fulvestrant Vs. Fulvestrant In Women With Estrogen Receptor-Positive, Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Experienced Disease Recurrence Or Progression During Or After CDK4 / 6 Inhibitor Therapy

    This is a Phase II, multicenter, open-label, randomized study to compare the efficacy of venetoclax in combination with fulvestrant compared with fulvestrant alone in women with ER+, HER2-negative, inoperable, locally advanced or MBC who experienced disease recurrence or progression during or after treatment with CDK4 / 6i therapy for at least 8 weeks.
    Location: 10 locations

  • Alisertib with or without Fulvestrant in Treating Patients with Locally Advanced or Metastatic, Endocrine-Resistant Breast Cancer

    This phase II trial studies how well alisertib with or without fulvestrant works in treating patients with endocrine-resistant breast cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread to other places in the body (metastatic). Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Giving alisertib with or without fulvestrant may work better in treating patients with breast cancer.
    Location: 10 locations

  • Tamoxifen Citrate, Anastrozole, or Fulvestrant in Treating Patients with Stage I-III Invasive Lobular Breast Cancer

    This phase II trial studies how well tamoxifen citrate, anastrozole, or fulvestrant work in treating patients with stage I-III invasive lobular breast cancer. Tamoxifen citrate and anastrozole may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. It is not yet known whether giving tamoxifen citrate, anastrozole, or fulvestrant will work better in treating patients with invasive lobular breast cancer.
    Location: 10 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: 10 locations

  • Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients with Bone Metastasis

    This phase II trial studies how well radiation therapy given with standard care palbociclib and hormone therapy work in treating patients with breast cancer that has spread from one part of the body to the bone. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Antihormone therapy, such as fulvestrant, letrozole, anastrozole, exemestane, or tamoxifen, may lessen the amount of estrogen made by the body. Giving radiation therapy, palbociclib, and hormone therapy may work better in treating breast cancer patients with bone metastasis.
    Location: 10 locations

  • Neratinib with or without Fulvestrant in Treating Patients with HER2 and Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer That Cannot Be Removed by Surgery

    This randomized phase II trial studies how well neratinib with or without fulvestrant works in treating patients with HER2 and estrogen receptor positive breast cancer that has spread to other places in the body or cannot be removed by surgery. Neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include HER2. 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. It is not yet known whether giving neratinib with or without fulvestrant will work better in treating patients with breast cancer.
    Location: 8 locations

  • Dose Escalation and Expansion Study of GSK525762 in Combination With Fulvestrant in Subjects With Hormone Receptor-positive (HR+) / Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced or Metastatic 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 HR+ / HER2- advanced or metastatic 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: 9 locations

  • Fulvestrant and Abemaciclib in Treating Patients with Hormone Receptor Positive Recurrent or Refractory Endometrial Adenocarcinoma

    This phase II trial studies how well fulvestrant and abemaciclib work in treating patients with hormone receptor positive endometrial adenocarcinoma that has come back or does not respond to treatment. Fulvestrant and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 6 locations

  • A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

    This study is designed to evaluate the efficacy, safety, and pharmacokinetics of several immunotherapy-based combination treatments in participants with inoperable locally advanced or metastatic HR-positive, HER2-negative breast cancer who have progressed during or following treatment with a cyclin-dependent kinase (CDK) 4 / 6 inhibitor in the first- or second-line setting, such as palbociclib, ribociclib, or abemaciclib. The study will be performed in two stages. During Stage 1, participants will be randomized to fulvestrant (control) or an atezolizumab-containing doublet or triplet combination. Those who experience disease progression, loss of clinical benefit, or unacceptable toxicity may be eligible to receive a new triplet combination treatment in Stage 2 until loss of clinical benefit or unacceptable toxicity. New treatment arms may be added and / or existing treatment arms may be closed during the course of the study on the basis of ongoing clinical efficacy and safety as well as the current treatments available.
    Location: 6 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 six 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), GDC-0077 in combination with fulvestrant (Arm D), GDC-0077 in combination with palbociclib and fulvestrant (Arm E), and GDC-0077 in combination with palbociclib, fulvestrant, and metformin (Arm F).
    Location: 5 locations

  • Palbociclib and Fulvestrant in Treating Patients with Hormone Receptor-Positive, HER2-Negative Metastatic or Locally Advanced Breast Cancer

    This phase II trial studies how well palbociclib and fulvestrant work in treating patients with hormone receptor positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other places in the body or that has only spread to nearby tissue or lymph nodes. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy such as fulvestrant may block the use of estrogen and progesterone by tumor cells. Giving palbociclib with fulvestrant may work better in treating patients with hormone receptor positive, HER2-negative breast cancer.
    Location: 5 locations

  • Palbociclib and Letrozole or Fulvestrant in Treating African American Participants with Hormone Receptor Positive HER2 Negative Advanced Recurrent or Metastatic Breast Cancer

    This phase II trial studies how well palbociclib and letrozole or fulvestrant work in treating African American participants with hormone receptor positive HER2 negative breast cancer that has come back or 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 can cause the growth of breast cancer cells. Drugs, such as letrozole and fulvestrant, may lessen the amount of estrogen made by the body. Giving palbociclib and letrozole or fulvestrant may work better in treating African American participants with hormone receptor positive HER2 negative breast cancer.
    Location: 5 locations

  • Evaluation of Lasofoxifene Versus Fulvestrant in Advanced or Metastatic ER+ / HER2− Breast Cancer With an ESR1 Mutation

    This is an open label, randomized, multicenter study evaluating the activity of lasofoxifene relative to fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic ER+ / HER2− breast cancer with an acquired ESR1 mutation and who have disease progression on an aromatase inhibitor (AI) in combination with a cyclin dependent kinase (CDK) 4 / 6 inhibitor. The primary objective is to evaluate the progression free survival (PFS) of 5 mg lasofoxifene relative to fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic estrogen receptor positive (ER+) / human epidermal growth factor 2 negative (HER2−) breast cancer with an ESR1 mutation. The secondary objectives are to evaluate: 1. Clinical benefit rate (CBR) and Objective Response Rate (ORR) 2. Duration of response 3. Time to response 4. Overall Survival (OS) 5. Pharmacokinetics of lasofoxifene 6. Quality of life (QoL): Quality of Life (QoL): vaginal assessment scale (VAS) and vulvar assessment scale (VuAS) questionnaires 7. Safety of lasofoxifene 8. Response to various ESR1 mutation (Y537S, Y537C, D538G, E380Q, S463P, V534E, P535H, L536H, L536P, L536R, L536Q, or Y537N) 9. The presence of the following mutations from tumor free DNA will be documented and part of an exploratory analysis: 1. erbb2 extracellular domain mutation 5310; 2. erbb2 kinase domain mutations V777, L755, and Exon 20 insertion; 3. all NF1 mutations that are truncating, frame shifting and nonsense or homozygous deletions; and 4. KRAS (Kirsten RAt Sarcoma).
    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. Immunotherapy with monoclonal antibodies, such as trastuzumab emtansine, pertuzumab, and trastuzumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. 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

  • Capivasertib 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 capivasertib 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. Capivasertib 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. Capivasertib with or without enzalutamide or fulvestrant may work better in treating patients with solid tumor with AKT1, AKT2, or AKT3 mutations.
    Location: 3 locations

  • Ribociclib and Spartalizumab with or without Fulvestrant in Treating Patients with Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer or Metastatic Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    This phase I trial studies the side effects and best dose of ribociclib when given together with spartalizumab with or without fulvestrant in treating patients with hormone receptor positive and HER2 negative breast cancer that has spread to other places in the body (metastatic), or ovarian, fallopian tube, or primary peritoneal cancer that has spread to other places in the body (metastatic). Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as spartalizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs, such as fulvestrant, may lessen the amount of estrogen made by the body. Giving ribociclib and spartalizumab with or without fulvestrant may work better in treating patients with breast, ovarian, fallopian tube, or primary peritoneal cancer.
    Location: 3 locations

  • 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: 6 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, F, D1 and D2): 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. The primary objective of cohorts D1 and D2 is to assess the anti-tumour activity of the triplet combination xentuzumab, abemaciclib and fulvestrant in patients with locally advanced / metastatic HR+ breast cancer who have progressed on prior endocrine therapy. Cohort D1 will assess the anti-tumour activity for subjects with visceral metastasis and Cohort D2 for subjects with non-visceral metastasis.
    Location: 4 locations


1 2 Next >