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 34
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  • Letrozole with or without Paclitaxel and Carboplatin in Treating Patients with Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    This phase III trial studies how well letrozole with or without paclitaxel and carboplatin works in treating patients with stage II-IV low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body which in turn may stop the growth of tumor cells that need estrogen to grow. 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. It is not yet known whether giving letrozole alone or in combination with paclitaxel and carboplatin works better in treating patients with low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum compared to paclitaxel and carboplatin without letrozole.
    Location: 451 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: 30 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: 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

  • 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

  • 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: 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

  • 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

  • Abemaciclib and Letrozole in Treating Patients with Recurrent, Metastatic, or Resistant Endometrial Cancer

    This phase II trial studies how well abemaciclib and letrozole work in treating patients with endometrial cancer that has come back, spread to other places in the body or is resistant to standard treatments. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Letrozole is a hormonal therapy that works by lowering the production of estrogen in the body. Estrogen may help to stimulate cancer cells to grow, so lowering the levels of estrogen in the body may work to slow cancer cell growth. Giving abemaciclib together with letrozole may work better in treating patients with endometrial 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, 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

  • 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. 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 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

  • Effects of Short-Term Hormone Therapy before Surgery on Gene Profiles in Patients with Stage I-III Breast Cancer

    This phase IV trial investigates the effects of short-term hormonal therapy (letrozole, exemestane or tamoxifen) before surgery on how genes are expressed (gene profiles) in patients with stage I-III breast cancer. Letrozole and exemestane may help fight breast cancer by lowering the amount of estrogen made by the body. Tamoxifen may help fight breast cancer by blocking the use of estrogen by the tumor cells. Information gained from this study may help researchers in advancing the individualized care to patients with breast cancer.
    Location: 2 locations

  • Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer

    QT interval prolongation and neutropenia are considered to be important identified risks for ribociclib (Kisqali® Prescribing Information, Investigator Brochure). The approved dosing regimen of ribociclib is 600 mg daily (QD) on a 3 weeks on / 1 week off schedule. The purpose of the study is to explore whether a reduced dosing regimen of 400 mg ribociclib orally QD 3 weeks on / 1 week off may decrease the risk of QTc prolongation without compromising the efficacy of ribociclib in combination with an NSAI in pre- and postmenopausal women with HR-positive, HER2-negative aBC who have received no prior therapy for advanced disease. The risks of other AEs of special interest, such as neutropenia and hepatobiliary toxicity will be evaluated in this study as well. Approximately 350 patients will be randomly assigned to one of the below treatment arms in a 1:1 ratio: Experimental arm (Arm 1) - Ribociclib 400 mg QD 3 weeks on / 1 week off + NSAI (+ goserelin in premenopausal women): 175 patients Control arm (Arm 2) - Ribociclib 600 mg QD 3 weeks on / 1 week off + NSAI (+ goserelin in premenopausal women): 175 patients Randomization will be stratified by the presence of lung and / or liver metastases (yes versus no).
    Location: 3 locations

  • PF-06952229 Treatment in Adult Patients With Advanced Solid Tumors

    A Phase 1 dose escalation study evaluating safety, tolerability and pharmacokinetics of PF-06952229 in adult patients with advanced solid tumors.
    Location: 3 locations

  • 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 everolimus and letrozole with or without ribociclib 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 by 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

  • 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: 2 locations

  • Anastrozole and Letrozole after Surgery for the Treatment of Stage I-III Breast Cancer

    This phase II trial studies how well anastrozole and letrozole after surgery work in treating patients with stage I-III breast cancer. Drugs, such as anastrozole and letrozole may stop the growth of tumor cells by decreasing the amount of estrogen made by the body. Giving anastrozole and letrozole after surgery may prevent breast cancer from coming back (recurrence).
    Location: Mayo Clinic in Rochester, Rochester, Minnesota

  • Aromatase Inhibitor Therapy with or without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer with an ERS1 Activating Mutation, the INTERACT Study

    This phase II trial studies how well letrozole, anastrozole, or fulvestrant work when given together with ribociclib, palbociclib, and / or abemaciclib in treating patients with hormone receptor (HR) positive breast cancer that has spread to other places in the body (metastatic) and has an ERS1 activating mutation. Letrozole, anastrozole, ribociclib, palbociclib, and abemaciclib 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 fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. It is not yet known if giving letrozole, anastrozole, or fulvestrant with ribociclib, palbociclib, and / or abemaciclib will work better in treating patients with breast cancer.
    Location: M D Anderson Cancer Center, Houston, Texas

  • 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 / or 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

  • Genetic Testing in Studying Letrozole Resistance in Post-Menopausal Patients with ER-positive or Her2-negative Operable Stages I-III Breast Cancer Pre-Surgery

    This trial studies gene expression to determine letrozole resistance in post-menopausal patients with estrogen receptor (ER)- positive or Her2-negative operable stages I-III breast cancer before surgery. Letrozole may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may be given before surgery to shrink the tumor. This genetic study may allow doctors to tell which patients will benefit from pre-surgery letrozole and may also help doctors to better customize treatments for breast cancer.
    Location: UT Southwestern / Simmons Cancer Center-Dallas, Dallas, Texas

  • Biological and Clinical Effects of Palbociclib With Ovarian Suppression and Letrozole in the Neoadjuvant Treatment of Breast Cancer

    This study will look at the safety and effectiveness of the combination of palbociclib and letrozole and ovarian suppression for premenopausal patients who have ER-positive / HER2-negative breast cancer that has not yet been treated.
    Location: Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center, Houston, Texas


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