Clinical Trials Using Anastrozole

Clinical trials are research studies that involve people. The clinical trials on this list are studying Anastrozole. 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 1-17 of 17
  • 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

  • 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

  • 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: 9 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 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

  • PD 0332991 and Anastrozole for Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer

    This phase II trial studies palbociclib isethionate together with anastrozole and to see how well they work in treating patients with estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) stage II or III breast cancer. Palbociclib isethionate may stop tumor growth by blocking an enzyme needed for cell division and growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by lowering the amount of estrogen the body makes. Giving palbociclib isethionate together with anastrozole may be an effective treatment for ER+ HER2- breast cancer.
    Location: 4 locations

  • Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in Treating Participants with HR-Positive, HER2-Positive Metastatic Breast Cancer

    This phase I / II trial studies the side effects and best dose of anastrozole, palbociclib, trastuzumab and pertuzumab and how well they work in treating participants with hormone receptor-(HR) positive, HER2-positive breast cancer that has spread to other locations in the body. Anastrozole and palbociclib are enzyme inhibitors that may stop the growth of tumor cells by blocking some of the enzymes needed cell growth. Monoclonal antibodies, such as trastuzumab and pertuzumab may interfere with the ability of tumor cells to grow and spread. Giving anastrozole, palbociclib, trastuzumab and pertuzumab may work better in treating participants with HR+, HER2+ metastatic breast cancer.
    Location: 6 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

  • 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

  • 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

  • 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: Emory University Hospital / Winship Cancer Institute, Atlanta, Georgia

  • Endocrine Therapy in Treating Patients with HER2 Negative, Low Risk Breast Cancer

    This pilot phase IV trial studies how well endocrine therapy works in treating patients with HER2 negative, low risk breast cancer. Estrogen can cause the growth of breast cancer cells. Endocrine therapies such as aromatase inhibitors and selective estrogen receptor modulators may lessen the amount of estrogen made by the body.
    Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington

  • Talimogene Laherparepvec with Paclitaxel or Endocrine Therapy in Treating Participants with Metastatic, Unresectable, or Recurrent HER2- Negative Breast Cancer

    This phase Ib trials studies the side effects and how well talimogene laherparepvec works when given together with paclitaxel or endocrine therapy in treating participants with breast cancer that does not express the human epidermal growth factor receptor 2 (HER2) protein and has spread to other places in the body, cannot be removed by surgery, or has come back after. Biological therapies, such as talimogene laherparepvec, use substances made from living organisms that may attack specific tumor cells and stop them from growing or kill them. 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. Drugs used as endocrine therapy, such as letrozole, anastrozole, exemestane, tamoxifen or fulvestrant, may lessen the amount of estrogen made by the body or may may stop the growth of tumor cells by blocking estrogen from connecting to the cancer cells. Giving talimogene laherparepvec with paclitaxel or endocrine therapy may work better in treating participants with HER2-negative breast cancer.
    Location: UCSF Medical Center-Mount Zion, San Francisco, California

  • S1222 Trial (Everolimus, Anastrozole and Fulvestrant) in Post-Menopausal Stage IV Breast Cancer

    This randomized Phase III trial studies how well the combination of fulvestrant and everolimus together or the combination of anastrozole, fulvestrant and everolimus together, improve progression-free survival (PFS) versus fulvestrant alone.
    Location: See Clinical Trials.gov