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 26-50 of 57

  • 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. Monoclonal antibodies, such as trastuzumab, 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

  • 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

  • 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: 3 locations

  • Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)

    AINV18P1 is a Phase 1 study where palbociclib will be administrated in combination with a standard re-induction platform in pediatric relapsed Acute Lymphoblastic Leukemia (ALL) and lymphoblastic lymphoma (LL). LL patients are included because the patient population is rare and these patients are most commonly treated with ALL regimens. The proposed starting dose for this study will be 50 mg / m^2 / day for 21 days.
    Location: 2 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 and irinotecan) 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: 9 locations

  • Palbociclib with or without Binimetinib or Binimetinib Alone in Treating Patients with Advanced KRAS Mutant Non-small Cell Lung Cancer

    This randomized phase I trial studies the side effects and best dose of palbociclib and binimetinib and to see how well they work in treating patients with KRAS mutant non-small cell lung cancer that has spread to other places in the body. Palbociclib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 3 locations

  • Alternative Dosing Schedule of Palbociclib and Letrozole or Fulvestrant with or without Goserelin Acetate in Treating Patients with Metastatic Hormone Receptor Positive Breast Cancer

    This phase II trial studies the side effects of an alternative dosing schedule of palbociclib and letrozole or fulvestrant with or without goserelin acetate in treating patients with hormone 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. Estrogen and progesterone can cause the growth of breast tumor cells. Hormone therapy using letrozole, fulvestrant, and goserelin acetate may fight hormone receptor positive breast cancer by blocking the use of estrogen and progesterone by the tumor cells. Giving an alternative dosing schedule of palbociclib and letrozole or fulvestrant with or without goserelin acetate may work better in treating patients with hormone receptor positive breast cancer.
    Location: 2 locations

  • Fulvestrant and Palbociclib in Treating Older Patients with Hormone Responsive Breast Cancer That Cannot Be Removed by Surgery

    This phase II trial studies how well fulvestrant and palbociclib works in treating older patients with breast cancer that responds to hormone treatment (hormone responsive) that cannot be removed by surgery. Estrogen can cause the growth of estrogen-receptor-positive breast cancer cells. Hormone therapy using fulvestrant may fight estrogen-receptor-positive breast cancer by blocking the use of estrogen by the tumor cells. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving fulvestrant together with palbociclib may be an effective treatment for hormone responsive breast cancer.
    Location: 2 locations

  • Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer

    This is a non-randomized, open-label, single-arm, multicenter, phase II study of palbociclib in combination with tamoxifen in women with HR(+) / HER2(-) advanced breast cancer who have not received prior systemic anticancer therapies for their advanced / metastatic disease.
    Location: 2 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

  • Palbociclib, Bosutinib, and Fulvestrant for the Treatment of Metastatic Hormone Receptor Positive and HER2 Negative Breast Cancer Refractory to Aromatase Inhibitors

    This trial studies the side effects and best dose of bosutinib and palbociclib when given together with fulvestrant in treating patients with hormone receptor positive and HER2 negative breast cancer that has spread to other places in the body (metastatic) and does not respond to aromatase inhibitor therapy (refractory to aromatase inhibitors). Bosutinib and palbociclib may stop the growth of cancer 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. This study is being done because it is not known if this combination therapy can be safely used at effective doses, preventing or postponing the need to start treatment with chemotherapy.
    Location: MedStar Georgetown University Hospital, Washington, District of Columbia

  • 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

  • Avelumab and Tamoxifen with or without Palbociclib in Treating Patients with Stage I-III Estrogen Receptor Positive Breast Cancer

    This phase II trial studies how well avelumab and tamoxifen given with or without palbociclib work in treating patients with stage I-III estrogen receptor positive breast cancer. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as tamoxifen, 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. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not known whether giving avelumab and tamoxifen with or without palbociclib will work better in treating patients with breast cancer.
    Location: Johns Hopkins University / Sidney Kimmel Cancer Center, Baltimore, Maryland

  • Palbociclib before Surgery in Treating Patients with Stage 0-I Ductal Breast Carcinoma in Situ

    This phase II trial studies how well palbociclib when given before surgery works in treating patients with stage 0-I ductal breast carcinoma in situ. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving palbociclib before surgery may work better in treating patients with ductal breast carcinoma in situ compared to surgery alone.
    Location: MedStar Georgetown University Hospital, Washington, District of Columbia

  • Avelumab, Palbociclib, and Cetuximab in Treating Patients with Recurrent or Metastatic Head and Neck Squamous Cell Cancer

    This phase I trial studies the side effects and best dose of palbociclib, when given together with avelumab and cetuximab, in treating patients with head and neck squamous cell cancer that has come back or spread to other parts of the body. Immunotherapy with monoclonal antibodies, such as avelumab and cetuximab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving avelumab, palbociclib, and cetuximab may work better in treating patients with recurrent or metastatic head and neck squamous cell cancer.
    Location: University of California San Diego, San Diego, California

  • Palbociclib and Dexamethasone in Treating Patients with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

    This phase I trial studies the side effects and best dose of palbociclib when given together with dexamethasone in treating patients with B-cell acute lymphoblastic leukemia that has come back after a period of improvement or does not respond to treatment. Palbociclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Dexamethasone is a steroid medication that is used in combination with other medications to treat B-cell acute lymphoblastic leukemia. Giving palbociclib together with dexamethasone may work better in treating patients with B-cell acute lymphoblastic leukemia.
    Location: Thomas Jefferson University Hospital, Philadelphia, Pennsylvania

  • Ulixertinib and Palbociclib in Treating Patients with Advanced or Refractory Solid Tumors or Metastatic Pancreatic Cancer

    This phase I trial studies the side effects and best dose of ulixertinib and palbociclib and to see how well they work in treating patients with solid tumors that have spread to other places in the body or do not respond to treatment or pancreatic cancer that has spread to other places in the body. Ulixertinib and palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina

  • Palbociclib and Intensity-Modulated Radiation Therapy with Cisplatin or Cetuximab in Treating Patients with Head and Neck Squamous Cell Cancer

    This phase II trial studies how well palbociclib and intensity-modulated radiation therapy with cisplatin or cetuximab works in treating patients with head and neck squamous cell cancer. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, 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. Immunotherapy with monoclonal antibodies, such as cetuximab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Intensity-modulation radiation therapy uses varying intensities of radiation beams to kill cancer cells and shrink tumors, thereby reducing the damage to nearby healthy tissue. It is not yet known whether giving palbociclib and intensity-modulated radiation therapy with cisplatin or cetuximab works better at treating head and neck squamous cell cancer.
    Location: Siteman Cancer Center at Washington University, Saint Louis, Missouri

  • Survival Prolongation by Rationale Innovative Genomics

    Patients with advanced / metastatic non-small cell lung cancer (NSCLC) with no documented targetable alterations (Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic Lymphoma Kinase (ALK) translocation, ROS1 mutation if available or MET exon 14 skipping mutation if available) will receive a tri-therapy associating avelumab, axitinib and palbociclib.
    Location: University of California San Diego, San Diego, California

  • Fulvestrant, Palbociclib, and pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Treating Patients with Estrogen Receptor Positive, HER2 Negative, and FGFR Amplified Stage IV Breast Cancer That Is Recurrent or Cannot Be Removed by Surgery

    This phase Ib trial studies the side effects and best dose of pan-FGFR tyrosine kinase inhibitor JNJ-42756493 when given together with fulvestrant and palbociclib in treating patients with estrogen receptor positive, HER2 negative, and FGFR amplified stage IV breast cancer that has come back or cannot be removed by surgery. 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. Palbociclib and pan-FGFR tyrosine kinase inhibitor JNJ-42756493 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving fulvestrant, palbociclib, and pan-FGFR tyrosine kinase inhibitor JNJ-42756493 may work better in treating patients with breast cancer.
    Location: 6 locations

  • Palbociclib and Sorafenib, Decitabine, or Dexamethasone in Treating Patients with Recurrent or Refractory Leukemia

    This phase I trial studies the side effects and best dose of palbociclib when given alone and in combination with sorafenib, decitabine, or dexamethasone in treating patients with leukemia that has come back (recurrent) or that does not respond to previous treatment (refractory). Palbociclib, sorafenib, and decitabine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, 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 palbociclib alone and in combination with sorafenib, decitabine, or dexamethasone may work better in treating patients with recurrent or refractory leukemia.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Neratinib and Everolimus, Palbociclib, or Trametinib in Treating Participants with Refractory and Advanced or Metastatic Solid Tumors with EGFR Mutation / Amplification, HER2 Mutation / Amplification, or HER3 / 4 Mutation or KRAS Mutation

    This phase I trial studies the side effects and best dose of neratinib in combination with everolimus, palbociclib, or trametinib in participants with solid tumors with EGFR mutation / amplification, HER2 mutation / amplification, HER3 / 4 mutation, or KRAS mutation that do not respond to treatment (refractory) and have spread to other parts of the body (advanced or metastatic). Neratinib, palbociclib, and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as everolimus, 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 neratinib with everolimus, palbociclib, or trametinib may work better than neratinib alone in treating participants with solid tumors.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Palbociclib with Cisplatin or Carboplatin in Treating Patients with Advanced Solid Tumors

    This phase I trial studies the side effects and best dose of palbociclib with cisplatin or carboplatin in treating patients with solid tumors that have spread to other places and usually cannot be cured or controlled with treatment. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin 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. Giving palbociclib with cisplatin or carboplatin may help stop tumor growth in patients with advanced solid tumors.
    Location: Emory University Hospital / Winship Cancer Institute, Atlanta, Georgia

  • A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer

    This is a phase I, open-label study of D-0502 single agent and D-0502 in combination with standard dose of palbociclib to assess the safety and tolerability, identify an MTD, and / or RP2D, evaluate the PK properties and evaluate preliminary anti-tumor activities in women with advanced or metastatic ER-positive, HER2-negative breast cancer.
    Location: Cancer Therapy and Research Center at The UT Health Science Center at San Antonio, San Antonio, Texas

  • A Study of Telaglenastat (CB-839) in Combination With Palbociclib in Patients With Solid Tumors

    This is a Phase 1b / 2 study to determine the recommended phase 2 dose (RP2D), safety and tolerability, pharmacokinetics (PK) and clinical activity of the glutaminase inhibitor telaglenestat (CB-839) with the CDK4 / 6 Inhibitor, palbociclib in participants with advanced / metastatic solid tumors.
    Location: 2 locations