Clinical Trials Using Palbociclib

Clinical trials are research studies that involve people. The clinical trials on this list are studying Palbociclib. 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 54
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  • Targeted Therapy Directed by Genetic Testing in Treating Patients with Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

    This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.
    Location: 1205 locations

  • Palbociclib in Treating Patients with Relapsed or Refractory Rb Positive Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders with Activating Alterations in Cell Cycle Genes (A Pediatric MATCH Treatment Trial)

    This phase II Pediatric MATCH trial studies how well palbociclib works in treating patients with Rb positive solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with activating alterations (mutations) in cell cycle genes that have spread to other places in the body and have come back or do not respond to treatment. Palbociclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
    Location: 113 locations

  • Fulvestrant with or without Palbociclib and Avelumab in Treating Patients with Hormone Receptor Positive, HER2 Negative Metastatic or Recurrent Breast Cancer That Cannot Be Removed by Surgery Previously Treated with CDK and Endocrine Therapy

    This randomized pilot phase II trial studies how well fulvestrant with or without palbociclib and avelumab works in treating patients with hormone receptor positive, HER2 negative breast cancer that has spread to other parts of the body or that has come back after a period of improvement and cannot be removed by surgery, and have been previously treated with CDK and endocrine therapy. Endocrine therapy with fulvestrant prevents growth of hormone receptor positive breast cancer by blocking stimulation of tumor cells by estrogen. Palbociclib is a drug that may stop tumor cells from growing by blocking activity of two closely related enzymes (proteins that help chemical reactions in the body occur), called cyclin dependent kinases 4 and 6 (CDK 4 / 6) which are known to promote tumor cell growth. Monoclonal antibodies, such as avelumab, may help the immune system in detecting and fighting tumor cells. Giving fulvestrant with or without palbociclib and avelumab may work better in treating patients with breast cancer.
    Location: 30 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: 26 locations

  • Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent / Refractory Solid Tumors

    This study will evaluate palbociclib in combination with chemotherapy (temozolomide with irinotecan and topotecan with cyclophosphamide) in children, adolescents and young adults with recurrent or refractory solid tumors. The main purpose of this study is to evaluate the safety of palbociclib in combination with chemotherapy in order to estimate the maximum tolerated dose. Pharmacokinetics and efficacy of palbociclib in combination with chemotherapy will be evaluated.
    Location: 24 locations

  • T-DM1 and Palbociclib in Treating Patients with Metastatic HER2 Positive Breast Cancer

    This phase II trial studies how well T-DM1 and palbociclib work in treating patients with HER2 positive breast cancer that has spread to other parts of the body (metastatic). T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called DM1. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers DM1 to kill them. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and palbociclib may help treat patients with HER2 positive metastatic breast cancer.
    Location: 17 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 (bone metastasis). 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. Estrogen can cause the growth of breast cancer cells. Letrozole, anastrozole, and exemestane lowers the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. Fulvestrant and tamoxifen blocks the use of estrogen by the tumor cells. Giving radiation therapy, palbociclib, and hormone therapy may work better in treating breast cancer patients with bone metastasis.
    Location: 11 locations

  • TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer

    The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug. NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact TAPUR@asco.org, or if a patient, your nearest participating TAPUR site (see participating centers). ********************************************************************************************* ********************************************************************************* Results in publication or poster presentation format are posted as they become available for individual cohorts at www.tapur.org / news. The results may be accessed at any time. All results will be made available on clinicaltrials.gov at the end of the study. Indexing of available results on PubMed is in progress. ********************************************************************************************* *********************************************************************************
    Location: 11 locations

  • A Study of ZN-c5 in Subjects With Breast Cancer

    This is a Phase 1 / 2, open-label, multicenter, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZN-c5 administered orally in subjects with advanced estrogen receptor positive, human epidermal growth factor receptor 2 negative (ER+ / HER2-) breast cancer. ZN-c5 will be evaluated both as monotherapy and in combination with palbociclib (IBRANCE®).
    Location: 8 locations

  • Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma

    The proposed study is a single-arm, multi-center, open-label phase II study of the combination of palbociclib and ibrutinib in patients with previously treated mantle cell lymphoma to evaluate the efficacy of this combination, with the primary objective of the study being to assess median PFS and the secondary objectives to include ORR, CR, DOR, OS and toxicity. Subjects will be enrolled and treated with palbociclib and ibrutinib with each cycle of therapy being 28 days. Treatment will be based on the recommended phase II dose (RP2D) from the phase I combination trial.
    Location: 7 locations

  • Phase 1 / 2 Study of SAR439859 Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer

    Primary Objectives: Dose Escalation: Part A (SAR439859 monotherapy); Part C (combination of SAR439859 with palbociclib); Part F (Safety-Run-In - combination of SAR439859 with alpelisib): -To determine the maximum tolerated dose (MTD) and recommended dose (RD) of SAR439859 based on the dose-limiting toxicity observance in monotherapy (Part A) and in combination with palbociclib (Part C), and to confirm the combination RD with alpelisib (Part F). Dose Expansion: Part B (SAR439859 monotherapy): -To assess antitumor activity by Objective Response Rate (ORR) at the SAR439859 recommended dose in monotherapy Dose Expansion: Part D (combination of SAR439859 with palbociclib) and Part G (combination of SAR439859 with alpelisib): -Overall safety profile of SAR439859 in combination with palbociclib or alpelisib Secondary Objectives: - Overall safety profile of SAR439859 as monotherapy (Parts A,B), in combination with palbociclib (Part C) or in combination with alpelisib (Part F) - Pharmacokinetic (PK) profile of SAR439859 as monotherapy (Parts A,B), in combination with palbociclib (Parts C,D), in combination with alpelisib (Parts F,G), and PK of palbociclib (Parts C,D) and alpelisib (Parts F,G) alone and / or with SAR439859 - Antitumor activity of SAR439859 as monotherapy (Part A), in combinations with palbociclib (Part C,D) or alpelisib (F,G), and Clinical Benefit Rate (CBR: CR, PR and SD≥24 weeks) in Parts A,B,C,D,F,G - ORR and CBR in Parts B, D and G per estrogen receptor 1 (ESR1) gene mutational status (mutant and wild type) at baseline and in treatment - Time to 1st response (CR,PR) (Part B,D,G) - Residual ER availability with [(18)F] Fluoroestradiol Positron Emission Tomography (FES PET) scan (Part A) - To assess potential induction / inhibition effect of SAR439859 on CYP3A (Part A,B)
    Location: 7 locations

  • Pembrolizumab, Endocrine Therapy, 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 endocrine therapy 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 and fulvestrant, 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, palbociclib, and letrozole or fulvestrant may be an effective treatment for patients with stage IV estrogen receptor positive breast cancer.
    Location: 7 locations

  • A Phase 1 / 2 Trial of ARV-471 Alone and in Combination With Palbociclib (IBRANCE®) in Patients With ER+ / HER2- Locally Advanced or Metastatic Breast Cancer

    This is a Phase 1 / 2 dose escalation and cohort expansion study and will assess the safety and tolerability of ARV-471 alone and in combination with palbociclib (IBRANCE®) in patients with estrogen receptor positive / human epidermal growth factor receptor 2 negative (ER+ / HER2-) locally advanced or metastatic breast cancer, who have received prior hormonal therapy and chemotherapy in the locally advanced / metastatic setting.
    Location: 7 locations

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

    This phase II trial studies how well palbociclib and fulvestrant work in treating patients with hormone receptor positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other places in the body (metastatic) or that has only spread to nearby tissue or lymph nodes (locally advanced). Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy such as fulvestrant may block the use of estrogen and progesterone by tumor cells. Giving palbociclib with fulvestrant may work better in treating patients with hormone receptor positive, HER2-negative breast cancer.
    Location: 6 locations

  • Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer

    Primary Objective: To determine whether Amcenestrant (SAR439859) in combination with palbociclib improvesprogression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with ER+, HER2- advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease. Secondary Objective: - To compare the overall survival in both treatment arms - To evaluate the objective response rate in both treatment arms - To evaluate the duration of response in both treatment arms - To evaluate the clinical benefit rate in both treatment arms - To evaluate progression-free survival on next line of therapy - To evaluate the pharmacokinetics of amcenestrant, and palbociclib - To evaluate health-related quality of life in both treatment arms - To evaluate the time to first chemotherapy in both treatment arms - To evaluate safety in both treatment arms
    Location: 9 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. Trastuzumab is a form of targeted therapy because it attaches itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Monoclonal antibodies, such as 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

  • To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib 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 inavolisib administered orally as a single agent in patients with locally advanced or metastatic PIK3CA-mutant solid tumors, including breast cancer, and in combination with standard-of-care endocrine and / or targeted therapies for the treatment of locally advanced or metastatic PIK3CA-mutant 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 seven regimens: inavolisib as a single agent (Arm A), inavolisib in combination with palbociclib and letrozole (Arm B), inavolisib in combination with letrozole (Arm C), inavolisib in combination with fulvestrant (Arm D), inavolisib in combination with palbociclib and fulvestrant (Arm E), inavolisib in combination with palbociclib, fulvestrant, and metformin (Arm F), and inavolisib in combination with trastuzumab and pertuzumab (and letrozole or fulvestrant, if applicable (Arm G)).
    Location: 5 locations

  • PF-07104091 as a Single Agent and in Combination Therapy

    To assess the safety and tolerability of increasing doses of PF-07104091 and to estimate the Maximum Tolerated Dose (MTD) and / or select the Recommended Phase 2 dose (RP2D) for PF 07104091 as a single agent in participants with small cell lung, non small cell lung ovarian and breast cancers.
    Location: 4 locations

  • A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)

    This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer.
    Location: 7 locations

  • A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer

    This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in patients with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.
    Location: 5 locations

  • Palbociclib and Ganitumab for the Treatment of Relapsed or Refractory Ewing Sarcoma

    This phase II trial studies how well palbociclib and ganitumab work in patients with Ewing sarcoma that has come back (relapsed) or does not respond to treatment (refractory). Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as ganitumab, 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 and ganitumab may work better in treating patients with Ewing sarcoma compared to either palbociclib or ganitumab alone.
    Location: 4 locations

  • Palbociclib and Cetuximab in Treating Participants with Metastatic Colorectal Cancer and Non-Mutated KRAS, NRAS, and BRAF Genes

    This phase II trial studies how well palbociclib and cetuximab work in treating participants with colorectal cancer that has spread to other places in the body (metastatic) and have the proteins KRAS, NRAS, and BRAF that are not genetically mutated (wild type). Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, may interfere with the ability of tumor cells to grow and spread. Giving palbociclib and cetuximab together may work better in treating participants with wild-type metastatic colorectal cancer.
    Location: 4 locations

  • Palbociclib and Gedatolisib in Treating Patients with Advanced Solid Tumors or Lung, Pancreatic, or Head and Neck Cancer

    This phase I trial studies the side effects and best dose of palbociclib and gedatolisib and how well they work in treating patients with solid tumors or lung, pancreatic, or head and neck cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Palbociclib and gedatolisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 4 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

  • Stereotactic Radiosurgery with Abemaciclib, Ribociclib, or Palbociclib in Treating Patients with Hormone Receptor Positive Breast Cancer with Brain Metastases

    This phase I trial studies the side effects of stereotactic radiosurgery with abemaciclib, ribociclib, or palbociclib in treating patients with hormone receptor positive breast cancer that has spread to the brain (brain metasteses). Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Abemaciclib, ribociclib, and palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving abemaciclib, ribociclib, or palbociclib concurrently with stereotactic radiosurgery may reduce the side effects and / or increase the response to each of the therapies.
    Location: 3 locations


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