Clinical Trials Using Letrozole

Clinical trials are research studies that involve people. The clinical trials on this list are studying Letrozole. 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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  • 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: 390 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

  • 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

  • Tamoxifen Citrate or Letrozole with or without Palbociclib in Treating Patients with Stage I-III Invasive Breast Cancer before Surgery

    This phase II clinical trial studies how well tamoxifen citrate or letrozole with or without palbociclib work in treating patients with stage I-III invasive breast cancer before surgery. Antihormone therapies, such as tamoxifen citrate and letrozole, may lessen the amount of estrogen made by the body. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving tamoxifen citrate or letrozole with or without palbociclib may work better in treating patients with stage I-III invasive breast cancer.
    Location: 13 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

  • 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

  • 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: 11 locations

  • Pembrolizumab, Letrozole, and Palbociclib in Treating Postmenopausal Patients with Newly Diagnosed Metastatic Stage IV Estrogen Receptor Positive Breast Cancer

    This phase II trial studies how well pembrolizumab works when given together with letrozole and palbociclib in treating postmenopausal patients with newly diagnosed stage IV estrogen receptor positive breast cancer that has spread to other parts of the body (metastatic). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Estrogen can cause the growth of breast cancer cells. Antihormone therapy, such as letrozole, may lessen the amount of estrogen made by the body. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab, letrozole, and palbociclib may be an effective treatment for patients with stage IV estrogen receptor positive breast cancer.
    Location: 7 locations

  • Palbociclib, Letrozole, and Trastuzumab Emtansine in Treating Patients with Refractory HER2+ ER+ Metastatic Breast Cancer

    This phase I / II trial studies best dose of palbociclib and how well it works in combination with letrozole and trastuzumab emtansine in treating patients with HER2 positive (+) estrogen receptor (ER)+ breast cancer that has spread to other places in the body and has not responded to treatment. Palbociclib and letrozole may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as trastuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving palbociclib, letrozole, and trastuzumab may work better in treating patients with HER2+ ER+ breast cancer.
    Location: 6 locations

  • Pembrolizumab and Doxorubicin Hydrochloride or Anti-estrogen Therapy in Treating Patients with Triple-Negative or Hormone Receptor-Positive Metastatic Breast Cancer

    This phase II trial studies how well pembrolizumab and doxorubicin hydrochloride works compared to pembrolizumab with anti-estrogen therapy (anastrozole, letrozole, or exemestane) in treating patients with triple-negative or hormone-receptor positive breast cancer that has spread from the primary site (place where it started) to other places in the body. Pembrolizumab is an antibody drug that blocks a molecule called programmed cell death (PD)-1. PD-1 is a molecule that that shuts down the body's immune responses and prevents the immune system from attacking the cancer. Doxorubicin hydrochloride is a drug used in chemotherapy that works to stop the growth of tumor cells by stopping them from dividing and by causing them to die. Anti-estrogen therapy, including anastrozole, letrozole, and exemestane, lowers estrogen levels in the body, which may help treat cancer that is hormone receptor-positive. Giving pembrolizumab together with standard treatment of either doxorubicin hydrochloride (triple-negative cancer) or anti-estrogen therapy (hormone receptor-positive cancer) may be an effective treatment for these types of breast cancer.
    Location: 6 locations

  • Ribociclib and Letrozole Treatment in Ovarian Cancer

    The study evaluates the response to treatment with Ribociclib and Letrozole in patients with low grade serous cancer of the ovary, fallopian tube or peritoneum.
    Location: 10 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 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

  • 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: 4 locations

  • Palbociclib, Letrozole, and Trastuzumab before Surgery in Treating Patients with Estrogen Receptor Positive and HER2 Positive Stage II-III Breast Cancer

    This phase II trial studies how well palbociclib, letrozole, and trastuzumab work before surgery in treating patients with estrogen receptor (ER) positive and HER2 positive stage II-III breast cancer. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs, such as letrozole, may lessen the amount of estrogen made by the body. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells to grow and spread. Giving palbociclib, letrozole, and trastuzumab before surgery may work better in treating patients with breast cancer.
    Location: 3 locations

  • Anastrozole or Letrozole before Surgery in Treating Patients with Hormone Receptor Positive Stage II-III Breast Cancer That Can Be Removed by Surgery

    This pilot early phase I trial studies how well anastrozole or letrozole before surgery work in treating patients with hormone receptor positive stage II-III breast cancer that can be removed by surgery. Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole and letrozole may fight hormone receptor positive breast cancer by lowering the amount of estrogen the body makes and blocking the use of estrogen by the tumor cells.
    Location: 3 locations

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

    This study evaluates the safety of abemaciclib in combination therapies (letrozole, anastrozole, tamoxifen, exemestane, exemestane plus everolimus, trastuzumab, LY3023414 plus fulvestrant, pertuzumab plus trastuzumab with loperamide) for breast cancer that has spread to other parts of the body.
    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, 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: 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

  • Ketogenic Diet with Letrozole in Treating Patients with Estrogen Receptor Positive Breast Cancer

    This early phase I trial studies how well ketogenic diet with letrozole works in treating patients with estrogen receptor positive breast cancer. Estrogen receptor positive breast cancer has special proteins on it, called estrogen receptors, that allow it to grow when exposed to estrogen. A ketogenic diet (low calorie, low carbohydrate) may help normalize abnormally high insulin levels that in turn may slow the growth of cancer cells. Letrozole may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.The purpose of this study is to learn if the combination of a 2 week ketogenic diet in combination with letrozole can help slow the growth of tumors.
    Location: Vanderbilt University / Ingram Cancer Center, Nashville, Tennessee

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

    This phase Ib trial studies the side effects and best dose of ipatasertib when given together with aromatase inhibitor (letrozole, anastrozole, or exemestane), fulvestrant, and palbociclib in treating patients with hormone receptor positive, HER2 negative breast cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or to other places in the body (metastatic). Stopping (inhibiting) an enzyme called Akt in tumor cells may stop cancer resistance to standard of care treatment. Ipatasertib is a type of inhibitor that may stop the growth of tumor cells by inhibiting Akt. Through the different combinations of ipatasertib and the standard of care drugs, the chance of cancer cells becoming resistant to the standard of care drugs may decrease, causing cancer cells to stop growing and spreading.
    Location: Massachusetts General Hospital Cancer Center, Boston, Massachusetts

  • Durvalumab and Aromatase Inhibitor before Surgery in Treating Postmenopausal Patients with Hormone-Receptor-Positive Breast Cancer

    This phase II trial studies how well durvalumab and anastrozole (or other aromatase inhibitors) work when given before surgery in treating postmenopausal patients with hormone-receptor-positive breast cancer. Immunotherapy with monoclonal antibodies such as durvalumab may help the body’s immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Aromatase inhibitors, such as anastrozole, are hormonal blockers that are used in standard of care treatment of hormone receptor-positive breast cancer. This study may help find out how well durvalumab and anastrozole work when given before surgery in treating postmenopausal patients with hormone-receptor-positive breast cancer.
    Location: Moffitt Cancer Center, Tampa, Florida

  • Hydroxychloroquine, Palbociclib, and Letrozole before Surgery in Treating Participants with Estrogen Receptor Positive, HER2 Negative Breast Cancer

    This phase I / II trial studies the side effects and best dose of hydroxychloroquine when given together with palbociclib and letrozole before surgery in treating participants with estrogen receptor positive, HER2 negative breast cancer. Hydroxychloroquine is a substance that decreases immune responses 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, may lessen the amount of estrogen made by the body. Giving hydroxychloroquine, palbociclib, and letrozole before surgery may work better than palbociclib and letrozole in treating participants with breast cancer.
    Location: M D Anderson Cancer Center, Houston, Texas

  • MCLA-128 With Trastuzumab / Chemotherapy in HER2+ and With Endocrine Therapy in ER+ and Low HER2 Breast Cancer

    A Phase 2, open-label, multicenter international study will be performed to evaluate the efficacy of MCLA-128-based combinations. Three combination treatments will be evaluated, two in Cohort 1 and one in Cohort 2. MCLA-128 is given in combinations in two metastatic breast cancer (MBC) populations, HER2-positive / amplified (Cohort 1) and Estrogen Receptor-positive / low HER2 expression (Cohort2). Two combinations treatments will be evaluated in Cohort 1, the doublet and triplet. Initially MCLA-128 is given in combination with trastuzumab in the doublet. After the safety of the doublet has been assessed in 4-6 patients, MCLA-128 is given in combination with trastuzumab and vinorelbine in the triplet, in parallel to the efficacy expansion of the doublet. The doublet and triplet combinations are both evaluated in two steps with an initial safety run-in followed by a cohort efficacy expansion. In total up to 40 patients evaluable for efficacy are included in both the doublet and triplet. In Cohort 2 MCLA-128 is administered in combination with the same previous endocrine therapy on which progressive disease is radiologically documented. A total of up to 40 patients evaluable for efficacy are included in the Cohort 2.
    Location: Northwestern University, Chicago, Illinois

  • A Phase II, Two-Arm Study of Everolimus and Letrozole, + / - Ribociclib (Lee011) in Patients with Advanced or Recurrent Endometrial Carcinoma

    This phase II trial studies how well ribociclib, everolimus, and letrozole work in treating participants with endometrial cancer that has spread to other areas of the body or has come back. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as everolimus, and letrozole, work in different ways to sop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or b stopping them from spreading. Giving ribociclib, everolimus, and letrozole may work better than everolimus and letrozole in treating participants with endometrial cancer.
    Location: 2 locations


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