Clinical Trials Logo
  1. Home
  2. Breast Cancer
  3. NCT02448771

A Study of Palbociclib in Combination With Bazedoxifene in Hormone Receptor Positive Breast Cancer

Breast Cancer Stage IV Clinical Trial

Official title:
A Phase Ib/II Study of Palbociclib in Combination With Bazedoxifene in Hormone Receptor Positive Breast Cancer

Clinical Trial Summary

This research study is studying a drug called Palbociclib in combination with Bazedoxifene (a type of endocrine therapy, which prevents breast cancer cell growth by blocking estrogen stimulation) as a possible treatment for this diagnosis. The names of the study interventions involved in this study are: - Palbociclib - Bazedoxifene

Clinical Trial Description

This research study is a Phase I/II clinical trial. Phase II clinical trial tests the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. It also means that the FDA (the U.S. Food and Drug Administration) has not yet approved Palbociclib in combination with Bazedoxifene for use in participants with your type of cancer, but it has been approved for other uses (metastatic breast cancer). Palbociclib is a drug that may stop cancer cells from growing. Palbociclib blocks activity of two closely related enzymes (proteins that help chemical reactions in the body occur), called Cyclin D Kinases 4 and 6 (CDK 4/6). These proteins are part of a pathway, or a sequence of steps which is known to control cell growth. Laboratory testing has shown that palbociclib may stop the growth of hormone receptor positive breast cancer. Endocrine therapy prevents breast cancer cell growth by blocking the activity of the estrogen receptor. During this study the endocrine therapy will be bazedoxifene. In this research study, the investigators are evaluating how safe palbociclib is and how well palbociclib in combination with bazedoxifene, a form of endocrine treatment, works in participants with a history of stage four breast cancer. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02448771
Study type Interventional
Source Dana-Farber Cancer Institute
Contact
Status Completed
Phase Phase 1/Phase 2
Start date July 9, 2015
Completion date March 3, 2021
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04469127 - A Phase I/II Multicenter, Open-Label Study of Lu-177-DOTAGA-IAC, for the Treatment of Angiogenic Breast Cancer Patients. Phase 1/Phase 2
Withdrawn NCT03032614 - Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients Phase 2
Withdrawn NCT04123704 - Sitravatinib in Metastatic Breast Cancer Phase 2
Recruiting NCT05377047 - Stereotactic Ablative Radiotherapy for OligoMetastatic Breast Cancer N/A
Completed NCT03304210 - PIPAC Nab-pac for Stomach, Pancreas, Breast and Ovarian Cancer Phase 1
Completed NCT05054374 - A Study of Mirdametinib on Its Own or in Combination With Fulvestrant in People With Solid Tumor Cancer Phase 1/Phase 2
Recruiting NCT05559528 - BRaziLian outcomE for metAStatic breasT Cancer
Active, not recruiting NCT05090358 - Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer Phase 2
Recruiting NCT05033925 - Ficus Septica Leaves Fraction as a Complementary Therapy for Stadium IV Breast Cancer Patients Phase 1/Phase 2
Recruiting NCT03401359 - The Resistance and Immune Response to Palbociclib in Breast Cancer N/A
Active, not recruiting NCT03870919 - Locoregional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients N/A
Not yet recruiting NCT05860907 - Clinical Study of Huaier Granules in Patients With Advanced Breast Cancer Without Visceral Metastasis Phase 4
Completed NCT00393341 - Quantitation of Endothelial Progenitor Cells as Markers of Tumor Angiogenesis in Breast Cancer N/A
Recruiting NCT05625087 - Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib Phase 2
Completed NCT04566458 - RWD Study in HER2+ mBC Patients in Third-Line Therapy
Recruiting NCT06075810 - A Study of Oral MBQ-167 in Participants With Advanced Breast Cancer Phase 1
Recruiting NCT04697043 - The Benefit of Surgery in Stage IV of Breast Cancer N/A
Recruiting NCT05837533 - Multicenter Study to Evaluate a Systematized Communication Model for Breast Cancer Patients N/A
Active, not recruiting NCT03324425 - Simvastatin Plus Dual Anti-HER2 Therapy for Metastatic Breast Cancer Phase 2
Recruiting NCT05670054 - Cyclin Dependant Kinase 4/6 (CDK4/6) Inhibitors as a Second Line Treatment in Metastatic Breast Cancer Patients Phase 3