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COMPLETED

NCT03633331

PHASE2

Testing the Effects of Palbociclib and Fulvestrant or Letrozole for Patients 70 Years of Age of Older With Metastatic Breast Cancer

Sponsor: Alliance for Clinical Trials in Oncology

View on ClinicalTrials.gov

Summary

This phase II trial studies the side effects and how well palbociclib and letrozole or fulvestrant works in treating patients aged 70 years and older with estrogen receptor positive, HER2 negative breast cancer that has spread to other places in the body (metastases). Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as letrozole or 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. It is not known if giving palbociclib and letrozole or fulvestrant may work better in treating patients aged 70 and older with breast cancer.

Official title: A Phase II Trial Assessing the Tolerability of Palbociclib in Combination With Letrozole or Fulvestrant in Patients Aged 70 and Older With Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer

Key Details

Gender

All

Age Range

70 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2018-08-15

Completion Date

2026-02-27

Last Updated

2026-10-07

Healthy Volunteers

Conditions

Estrogen Receptor-positive Breast Cancer HER2/Neu Negative Stage IV Breast Cancer AJCC v6 and v7

Interventions

DRUG

Palbociclib

Given PO

DRUG

Letrozole

Given PO

DRUG

Fulvestrant

Given IM

OTHER

Questionnaire Administration

Ancillary studies

OTHER

Quality-of-Life Assessment

Ancillary studies

Locations (447)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States

Anchorage Radiation Therapy Center

Anchorage, Alaska, United States

Alaska Breast Care and Surgery LLC

Anchorage, Alaska, United States

Alaska Oncology and Hematology LLC

Anchorage, Alaska, United States

Alaska Women's Cancer Care

Anchorage, Alaska, United States

Anchorage Oncology Centre

Anchorage, Alaska, United States

Katmai Oncology Group

Anchorage, Alaska, United States

Providence Alaska Medical Center

Anchorage, Alaska, United States

Kingman Regional Medical Center

Kingman, Arizona, United States

PCR Oncology

Arroyo Grande, California, United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

City of Hope Corona

Corona, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

City of Hope Antelope Valley

Lancaster, California, United States

City of Hope Mission Hills

Mission Hills, California, United States

Saint Joseph Hospital - Orange

Orange, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

City of Hope - Santa Clarita

Santa Clarita, California, United States

City of Hope South Pasadena

South Pasadena, California, United States

City of Hope Upland

Upland, California, United States

City of Hope West Covina

West Covina, California, United States

Cancer Center of Colorado at Sloan's Lake

Denver, Colorado, United States

SCL Health Saint Joseph Hospital

Denver, Colorado, United States

Good Samaritan Medical Center

Lafayette, Colorado, United States

SCL Health Lutheran Medical Center

Wheat Ridge, Colorado, United States

Beebe Medical Center

Lewes, Delaware, United States

Delaware Clinical and Laboratory Physicians PA

Newark, Delaware, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Nanticoke Memorial Hospital

Seaford, Delaware, United States

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, United States

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

The Watson Clinic

Lakeland, Florida, United States

Hawaii Cancer Care Inc-POB II