Clinical trialNCT03633331CompletedPhase 2Interventional

Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer

SponsorAlliance for Clinical Trials in OncologyEnrollment93Estrogen Receptor-positive Breast CancerHER2/Neu NegativeStage IV Breast Cancer AJCC v6 and v7

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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. 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. Giving palbociclib and letrozole or fulvestrant may work better in treating patients with breast cancer. The trial will explore factors other than chronologic age that can affect toxicity rates as identified using a cancer-specific geriatric assessment.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Mina Sedrak, MD, MS
City of Hope Medical Center
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

447 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

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 Associates in Radiation Medicine
Anchorage, Alaska, United States
Anchorage Oncology Centre
Anchorage, Alaska, United States
Anchorage Radiation Therapy Center
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
Christiana Care Health System-Christiana Hospital
Newark, 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
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-Liliha
Honolulu, Hawaii, United States
Hawaii Cancer Care Inc-Pob Ii
Honolulu, Hawaii, United States
Hawaii Oncology Inc-Kuakini
Honolulu, Hawaii, United States
Hawaii Oncology Inc-Pob I
Honolulu, Hawaii, United States
Island Urology
Honolulu, Hawaii, United States

407 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Fulvestrant →Letrozole →Palbociclib →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 15 Aug 2018
Primary completion: 8 Sept 2020
Completion: 27 Feb 2026
Last update posted: 29 Apr 2026
Registered enrollment: 93
Registry id: NCT03633331

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.