Clinical Trials Using Ribociclib

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Clinical trials are research studies that involve people. The clinical trials on this list are studying Ribociclib. 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 1-24 of 24
  • 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

  • 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

  • Fulvestrant 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 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, cannot be removed by surgery, or has spread to other parts of the body. 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. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving fulvestrant with or without ribociclib may be an effective treatment for patients with breast cancer.
    Location: 11 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

  • Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced / Metastatic Breast Cancer Post Progression on CDK 4 / 6 Inhibitor.

    The purpose of this study is determine if the triplet combination of ribociclib, everolimus and exemastane is effective in the treatment of locally advanced / metastatic breast cancer following treatment with a CDK 4 / 6 inhibitor
    Location: 6 locations

  • Phase I / Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers

    To characterize the safety and tolerability, identify recommended doses and regimens for future studies, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of LSZ102 as a single agent and in combination with either LEE011 or BYL719 in adult patients with locally advanced or metastatic ER+ breast cancer who have progressed after endocrine therapy.
    Location: 4 locations

  • Enzalutamide with or without Ribociclib in Treating Patients with Metastatic Hormone-Resistant, Chemotherapy Naive Prostate Cancer That Retains Retinoblastoma Expression

    This partially randomized phase Ib / II trial studies the side effects and best dose of ribociclib when given with enzalutamide and to see how well they work compared to enzalutamide alone in treating patients with prostate cancer that does not respond to treatment with hormones (hormone resistant), has spread from the primary site (place where it started) to other places in the body (metastatic), is chemotherapy naive, and retains retinoblastoma expression. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether enzalutamide works better when given with or without ribociclib in treating patients with prostate cancer.
    Location: 4 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

  • Ribociclib with Trastuzumab or Trastuzumab Emtansine in Treating Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer

    This phase Ib / II trial studies the side effects and best dose of ribociclib with trastuzumab or trastuzumab emtansine and to see how well they work in treating patients with breast cancer that has spread from where it started to nearby tissue or lymph nodes or other places in the body and is human epidermal growth factor receptor 2 (HER2)-positive. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, block tumor growth in different ways by targeting certain cells. Immunotoxins, such as trastuzumab emtansine, are antibodies linked to a toxic substance and may help find tumor cells and kill them without harming normal cells. Giving ribociclib with trastuzumab emtansine or trastuzumab may work better in treating patients with breast cancer.
    Location: 3 locations

  • Ribociclib and Chemoembolization in Treating Patients with Advanced Liver Cancer

    This phase I / II trial studies the best dose and side effects of ribociclib when given together with chemoembolization in treating patients with liver cancer that has gotten worse. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemoembolization kills tumor cells by carrying drugs directly into blood vessels near tumors and then blocking the blood flow to allow a higher concentration of the drug to reach the tumor for a longer period of time. Giving ribociclib and chemoembolization may work better in treating patients with liver 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

  • Ribociclib and Everolimus in Treating Patients with Advanced Well Differentiated Neuroendocrine Tumors of Foregut Origin

    This phase II trial studies how well ribociclib and everolimus work in treating patients with well differentiated neuroendocrine tumors of foregut origin that have spread to other parts of the body and usually cannot be cured or controlled with treatment. Ribociclib and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 4 locations

  • Ribociclib (LEE011) Rollover Study for Continued Access

    This study is to allow continued use of ribociclib (LEE011) as single agent or in combination with other investigational treatments in patients benefitting from treatment in an eligible Novartis-sponsored ribociclib (LEE011) study that has reached its primary objective(s) or has been halted for other reasons.
    Location: 2 locations

  • Study of Safety and Efficacy of Ribociclib and Trametinib in Patients With Metastatic or Advanced Solid Tumors

    Phase Ib dose escalation in advanced solid tumors to identify dose for Phase II dose expansion in advanced or metastatic pancreatic cancer and KRAS-mutant colorectal cancer. Open-label, nonrandomized.
    Location: 3 locations

  • Ribociclib and Bicalutamide in AR+ TNBC

    This is an open label, multi-institutional, single arm phase II trial of ribociclib in combination with bicalutamide in advanced AR+ triple-negative breast cancer. No randomization or blinding is involved.
    Location: University of Wisconsin Hospital and Clinics, Madison, Wisconsin

  • Ribociclib with Carboplatin and Paclitaxel in Treating Patients with Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    This phase I trial studies the side effects and best dose of ribociclib with carboplatin and paclitaxel in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that 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 carboplatin and 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. Giving ribociclib with carboplatin and paclitaxel may work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.
    Location: University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan

  • A Phase 1B Study of Ribociclib in Combination with Doxorubicin in Advanced Soft Tissue Sarcomas

    This phase Ib trial studies the side effects and best dose of ribociclib when giving together with doxorubicin hydrochloride in treating patients with soft tissue sarcomas that has spread to other places or that cannot be removed by surgery. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride, 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 ribociclib and doxorubicin hydrochloride may work better in treating patients with soft tissue sarcoma.
    Location: OHSU Knight Cancer Institute, Portland, Oregon

  • Next Generation Personalized Neuroblastoma Therapy with Ribociclib and Ceritinib, Trametinib, or HDM2 Inhibitor HDM201 in Treating Younger Patients with High-Risk Neuroblastoma

    This phase I trial studies the side effects and best dose of ribociclib when given together with ceritinib, and HDM2 inhibitor HDM201, and to also see how well ribociclib and ceritinib, trametinib, or HDM2 inhibitor HDM201 work in treating patients with high-risk neuroblastoma. Ribociclib, ceritinib, trametinib, and HDM2 inhibitor HDM201 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Assigning patients to different treatment groups with ribociclib and ceritinib, trametinib, or HDM2 inhibitor HDM201 based on genetic testing may work better in treating neuroblastoma.
    Location: Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

  • Ribociclib and Paclitaxel in Treating Patients with Metastatic Rb+ Breast Cancer

    This phase I trial studies the side effects and the best dose of ribociclib when given together with paclitaxel in treating patients with breast cancer expressing retinoblastoma protein positive (Rb+) and has spread to other places in the body (metastatic). Ribociclib may stop the growth of tumor cells by blocking some proteins, such as Rb+, needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ribociclib together with paclitaxel may work better in treating patients with metastatic breast cancer.
    Location: University of Pennsylvania / Abramson Cancer Center, Philadelphia, Pennsylvania

  • Ribociclib, Docetaxel. and Prednisone in Treating Patients with Metastatic Hormone-Resistant Prostate Cancer

    This phase Ib / II trial studies the side effects and best dose of ribociclib when given together with docetaxel and prednisone and to see how well they work in treating patients with prostate cancer that has spread to other places in the body and does not respond to treatment with hormones. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel and prednisone, 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 ribociclib together with docetaxel and carboplatin may work better in treating metastatic hormone-resistant prostate cancer.
    Location: UCSF Medical Center-Mount Zion, San Francisco, California

  • Ribociclib and Gemcitabine Hydrochloride in Treating Patients with Advanced or Metastatic Solid Tumors

    This phase I trial studies the side effects and best dose of ribociclib and gemcitabine hydrochloride in treating patients with solid tumors that have spread to other places in the body. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, 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 ribociclib and gemcitabine hydrochloride may work better in treating patients with solid tumors.
    Location: 3 locations

  • Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+ / HER2- Intermediate 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, intermediate risk breast cancer.
    Location: 2 locations

  • Ribociclib and Everolimus in Treating Patients with Locally Advanced, Metastatic, or Refractory Dedifferentiated Liposarcoma or Leiomyosarcoma

    This phase II clinical trial studies how well ribociclib and everolimus work in treating patients with dedifferentiated liposarcoma or leiomyosarcoma that has spread to nearby tissue or to other places in the body or has not responded to treatment. Ribociclib and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: Fox Chase Cancer Center, Philadelphia, Pennsylvania

  • A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4 / 6 Therapy / LEE011 / Ribociclib

    This study will allow for the collection of tumor tissue samples to better understand relevant mutations and the mechanisms responsible for resistance to treatment.
    Location: Cancer Therapy and Research Center at The UT Health Science Center at San Antonio, San Antonio, Texas