Clinical Trials Using Letrozole

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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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  • 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: 1374 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: 1415 locations

  • Trametinib in Treating Patients with Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer

    This randomized phase II / III trial studies how well trametinib works and compares it to standard treatment with either letrozole, tamoxifen citrate, paclitaxel, pegylated liposomal doxorubicin hydrochloride, or topotecan hydrochloride in treating patients with low-grade ovarian cancer or peritoneal cavity cancer that has come back, become worse, or spread to other parts of the body. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether trametinib is more effective than standard therapy in treating patients with ovarian or peritoneal cavity cancer.
    Location: 461 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: 10 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: 11 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

  • 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

  • Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre / Postmenopausal Women With HR+ HER2- aBC

    The purpose of this Phase IIIb study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre / postmenopausal women with HR+HER2- advanced breast cancer.
    Location: 8 locations

  • Pembrolizumab, Letrozole, and Palbociclib in Treating Postmenopausal Patients with Newly Diagnosed Stage IV Estrogen Receptor Positive Breast Cancer with Stable Disease That Has Not Responded to Letrozole and Palbociclib

    This phase II trial studies how well pembrolizumab works when given together with letrozole and palbociclib in postmenopausal patients with newly diagnosed stage IV estrogen receptor positive breast cancer with stable disease that has not responded to letrozole and palbociclib. Monoclonal antibodies, such as pembrolizumab, 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: 6 locations

  • Letrozole with or without Ribociclib before Surgery in Treating Women with Stage II-III Estrogen Receptor-Positive, HER2-Negative Breast Cancer

    This randomized phase II trial studies how well letrozole with or without ribociclib work before surgery in treating women with stage II-III estrogen receptor-positive, HER2-negative breast cancer. Estrogen can cause the growth of breast cancer cells. Antihormone therapy, such as letrozole may lessen 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 letrozole and ribociclib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
    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

  • Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer

    The purpose of this trial is to inform the future clinical development of the two investigational agents in ER+ breast cancer, LEE011 (CDK4 / 6 inhibitor) and BYL719 (PI3K-alpha inhibitor). This is a multi-center, open-label Phase Ib study. The Phase Ib dose escalation will estimate the MTD and / or RP2D for three regimens: two double combinations, LEE011 with letrozole and BYL719 with letrozole, followed by triple combinations of LEE011 + BYL719 with letrozole (Arms 3 and 4). The Phase Ib dose escalation part will be followed by Phase Ib dose expansions to further characterize the safety, tolerability, PK and preliminary clinical anti-tumor activity of the combinations. Optional crossover for patients who have progressed while on dose escalation or dose expansion with doublet treatment on Arms 1 or 2 to be treated with the triplet combination (Arm 3) after the determination of the RP2D for Arm 3; is no longer permitted after protocol amendment 6. Approximately 250 adult women with ER+ / HER2- locally advanced or metastatic breast cancer will be enrolled.
    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 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

  • Everolimus, Letrozole, and Trastuzumab in Treating Patients with Hormone Receptor-Positive and HER2-Positive Advanced Metastatic Breast Cancer or Other Solid Tumors

    This phase I trial studies the side effects and best dose of everolimus and trastuzumab when given together with letrozole in treating patients with hormone receptor-positive and human epidermal growth factor (EGF) receptor 2 (HER2)-positive breast cancer or other solid tumors that have spread to other places in the body. Everolimus 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. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by tumor cells. Monoclonal antibodies, such as trastuzumab, may find tumor cells and help kill them. Giving everolimus, letrozole, and trastuzumab together may be a better treatment for breast cancer and other solid tumors.
    Location: 5 locations

  • Ribociclib and Letrozole in Treating Patients with Relapsed ER Positive Ovarian, Fallopian Tube, Primary Peritoneal, or Endometrial Cancer

    This phase II trial studies how well ribociclib and letrozole work in treating patients with estrogen receptor (ER) positive ovarian, fallopian tube, primary peritoneal, or endometrial cancer that has returned (come back) after a period of improvement. Ribociclib may stop the growth of tumor cells by blocking some enzymes needed for cell growth. Cancer cells that are estrogen receptor positive may need estrogen to grow. Letrozole lowers the amount of estrogen made by the body and this may stop the growth of tumor cells that need estrogen to grow. Giving ribociclib together with letrozole may be an effective treatment in patients with ovarian, fallopian tube, primary peritoneal, or endometrial cancer.
    Location: 3 locations

  • Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+ / HER2- High Risk Early Breast Cancer

    This is an international, multi-center, randomized, double-blinded, placebo-controlled clinical study evaluating the efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, high risk breast cancer.
    Location: 2 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

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

    This clinical 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: 2 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

  • Pazopanib Hydrochloride and Anastrozole or Letrozole in Treating Patients With Advanced Hormone-Resistant Breast Cancer

    The purpose of this study is to find out the effects, good and / or bad, of adding pazopanib (pazopanib hydrochloride) (the study drug) to current hormonal treatment (patients may take either anastrozole [Arimidex] or letrozole [Femara]). The study will see whether the combination is safe and easy to tolerate. If the study doctor is able to detect tumor cells in the blood before the treatment and / or during the treatment, he / she will also monitor the change of these tumor cells. Pazopanib is a drug taken by mouth that belongs to a class of medications called tyrosine kinase inhibitors. It works by slowing or stopping new blood vessel growth that can feed cancer growth.
    Location: 2 locations

  • Copanlisib, Letrozole, and Palbociclib in Treating Patients with Hormone Receptor Positive HER2 Negative Stage I-IV Breast Cancer

    This phase I / II trial studies side effects and best dose of copanlisib when given together with letrozole and palbociclib and to see how well they work in treating hormone receptor positive HER2 negative stage I-IV breast cancer. Copanlisib and 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. Giving copanlisib, letrozole, and palbociclib may work better in treating patients with breast cancer.
    Location: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California

  • 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

  • Paclitaxel and Carboplatin before Surgery in Treating Nigerian Women with Stage IIA-IIIC Breast Cancer

    This phase II trial studies how well paclitaxel works with carboplatin before surgery in treating Nigerian women with stage IIA-IIIC breast cancer before surgery. Drugs used in chemotherapy, such as 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.
    Location: University of Chicago Comprehensive Cancer Center, Chicago, Illinois

  • 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: Siteman Cancer Center at Washington University, Saint Louis, Missouri

  • Sapanisertib and Letrozole in Treating Patients with Estrogen Receptor Positive and HER2 Negative Stage I-IV Breast Cancer

    This phase Ib trial studies the side effects of sapanisertib and letrozole in treating patients with estrogen receptor positive and HER2 negative stage I-IV breast cancer. Sapanisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as letrozole, 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. Giving sapanisertib and letrozole before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
    Location: Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire


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