Clinical Trials Using Palbociclib

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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 38
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  • NCI-MATCH: Targeted Therapy Directed by Genetic Testing in Treating Patients with Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma

    This phase II 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: 1160 locations

  • Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients with Recurrent Stage IV Squamous Cell Lung Cancer

    This screening and multi-sub-study randomized phase II / III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid “Master Protocol” (S1400). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a “non-match” sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.
    Location: 903 locations

  • PALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+) / Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Early Breast Cancer

    This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer (EBC). The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+ / HER2- early breast cancer. Assessment of a variety of correlative analysis, including evaluation of the effect of palbociclib in genomically defined tumor subgroups, is planned.
    Location: 38 locations

  • Palbociclib Isethionate in Treating Younger Patients with Recurrent, Progressive, or Refractory Central Nervous System Tumors

    This phase I trial studies the side effects and best dose of palbociclib isethionate in treating younger patients with central nervous system tumors that have grown, come back, or not responded to treatment. Palbociclib isethionate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 13 locations

  • Palbociclib in Combination with Fulvestrant or Tamoxifen Citrate in Treating Patients with Locally Advanced or Metastatic Hormone Receptor Positive Breast Cancer

    This phase II trial studies the side effects of palbociclib when given together with fulvestrant or tamoxifen citrate in treating patients with hormone receptor positive breast cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy using fulvestrant or tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving palbociclib together with fulvestrant or tamoxifen citrate may work better in treating hormone receptor positive breast cancer.
    Location: 11 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

  • Palbociclib and Cetuximab in Treating Patients with Squamous Cell Carcinoma of the Head and Neck

    This phase I / II trial studies the side effects and best dose of palbociclib when given together with cetuximab and to see how well they work in treating patients with squamous cell carcinoma of the head and neck that has spread to other parts of the body or has returned and cannot be removed by surgery. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, may block tumor growth in different ways by targeting certain cells. Giving palbociclib and cetuximab may work better in treating patients with squamous cell carcinoma of the head and neck.
    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: 13 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. 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: 7 locations

  • Palbociclib and Bicalutamide in Treating Patients with Androgen Receptor Positive Metastatic Breast Cancer

    This phase I / II trial studies the side effects and best dose of palbociclib when given together with bicalutamide and to see how well they work in treating patients with androgen 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. Androgens can cause the growth of breast cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. Giving palbociclib and bicalutamide together may work better in treating androgen receptor positive breast cancer.
    Location: 6 locations

  • Dose-Escalation Study Of Palbociclib + Nab-Paclitaxel In mPDAC

    This is a Phase 1, open label, multi center, multiple dose, dose escalation, safety, pharmacokinetic and pharmacodynamic study of palbociclib in combination with nab-P, in sequential cohorts of adult patients with mPDAC, with MTD expansion cohort(s). Approximately 30-60 patients are expected to be enrolled in the overall study.
    Location: 6 locations

  • A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery

    The PENELOPEB study is designed to demonstrate that in the background of standard anti-hormonal therapy palbociclib provides superior invasive disease-free survival (iDFS) compared to placebo in pre- and postmenopausal women with HR-positive / HER2-normal early breast cancer at high risk of relapse after showing less than pathological complete response to neoadjuvant taxane- containing chemotherapy. Considering the high risk of recurrence in patients after neoadjuvant chemotherapy and a high CPS-EG score, palbociclib appears to be an attractive option with a favourable safety profile for these patients.
    Location: 7 locations

  • A Study of GDC-9545 Alone or in Combination With Palbociclib and / or Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Locally Advanced or Metastatic Estrogen Receptor-Positive Breast Cancer

    This study will evaluate the safety, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of GDC-9545 as a single agent and in combination with palbociclib and / or luteinizing hormone−releasing hormone (LHRH) agonist in patients with advanced or metastatic estrogen receptor (ER)-positive (human epidermal growth factor receptor 2 [HER2]-negative) breast cancer.
    Location: 5 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: 5 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

  • 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).
    Location: 6 locations

  • Study For Patients With NSCLC EGFR Mutations (Del 19 or L858R + / - T790M)

    This is a Phase 1 / 2 study of PF-06747775 as a single agent and in combination with other cancer treatments in patients with advanced EGFRm NSCLC. The overall clinical study consists of a Phase 1 single agent dose-escalation and expansion part to determine the RP2D of PF-06747775 single agent in patients with previously-treated EGFRm NSCLC followed by sequential evaluations of PF-06747775 at the RP2D in 3 different clinical scenarios as detailed below: - Cohort 1: Phase 2 evaluation of PF-06747775 as a single agent in previously untreated patients with advanced EGFRm NSCLC, - Cohort 2: Phase 1b single arm evaluation of PF-06747775 in combination with palbociclib (Cohort 2A) followed by Phase 2 randomized evaluation of PF 06747775 in combination with palbociclib vs PF-06747775 single agent (Cohort 2B) in previously-treated patients with EGFRm NSCLC with a secondary T790M mutation (del 19 and T790M or L858R and T790M), and - Cohort 3: Phase 1b evaluation of PF-06747775 in combination with avelumab in previously-treated patients with EGFRm NSCLC with a secondary T790M mutation (del 19 and T790M or L858R and T790M).
    Location: 5 locations

  • Palbociclib in Treating Patients with Metastatic Urothelial Cancer after First-Line Chemotherapy Failure

    This phase II trial studies how well palbociclib works in treating patients with urothelial cancer that has spread to other parts of the body and failed to respond to prior treatment with chemotherapy. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    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

  • Palbociclib in Treating Patients with Recurrent Brain Metastases with Alterations in the CDK Pathway

    This phase II trial studies how well palbociclib works in treating patients with cancer that has spread to the brain and has come back and that has alterations in the CDK pathway. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 3 locations

  • Palbociclib, Everolimus, and Exemestane in Treating Patients with Estrogen Receptor Positive and HER2 Negative Metastatic Breast Cancer

    This phase Ib / IIa trial studies the side effects and best dose of palbociclib and everolimus and how well they work when given together with exemestane in treating patients with estrogen receptor positive and human epidermal growth factor receptor 2 (HER2) negative breast cancer that has spread to other places in the body. Palbociclib, everolimus, and exemestane may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 3 locations

  • Palbociclib in Treating Patients with Metastatic HER-2 Positive Breast Cancer with Brain Metastasis

    The purpose of this study is to evaluate if the study drug palbociclib has anti-tumor activity against the breast cancer that has spread to the brain and also to determine the overall radiographic response rate in the central nervous system (CNS). Palbociclib is an anti-cancer medication that has been shown to stop cancer cells from growing. It has been approved in hormone positive breast cancer, along with other hormone therapies and has been found to be effective. The preclinical studies suggest that the drug may also have activity in other types of breast cancer, such as human epidermal growth factor receptor 2 (HER2) positive breast cancer. The purpose of this study is to see if the study drug is effective in patients with brain metastasis, who have HER2-positive breast cancer.
    Location: 3 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: 3 locations

  • Phase 1 / 2 Study of SAR439859 Single Agent and in Combination With Palbociclib 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) - To determine the maximum tolerated dose (MTD) and recommended dose (RD) of SAR439859 based on the dose-limiting toxicity (DLT) observance in monotherapy (Part A), and in combination with palbociclib (Part C) Dose Expansion: Part B (SAR439859 monotherapy); Part D (combination SAR439859 with palbociclib) - To assess antitumor activity by Objective Response Rate (ORR) at the SAR439859 recommended dose in monotherapy (Part B), and in combination with palbociclib (Part D) Secondary Objectives: - To characterize the overall safety profile of SAR439859 as monotherapy (Parts A and B), and in combination with palbociclib (Parts C and D) - To characterize the pharmacokinetic (PK) profile of SAR439859 as monotherapy (Parts A and B), and of SAR439859 in combination with palbociclib (Parts C and D), as well as of palbociclib in combination with SAR439859 (Parts C and D) - To evaluate antitumor activity of SAR439859 as monotherapy (Part A), and in combination with palbociclib (Part C) as well as the disease control rate (DCR) in Parts A, B, C, and D - To evaluate ORR and DCR (Complete Response [CR], Partial Response [PR] and Stable Disease [SD] ≥6 months) in Parts B and D according to the estrogen receptor 1 (ESR1) gene mutational status (mutant and wild type) - To evaluate residual estrogen receptor (ER) availability with [(18)F] Fluoroestradiol Positron Emission Tomography (FES PET) scan (Part A)
    Location: 2 locations


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