OncRef

Clinical Trial: NCT03633331

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

Status:

COMPLETED

Phase:

Phase 2

Lead Sponsor:Alliance for Clinical Trials in Oncology
Information Provided By:Alliance for Clinical Trials in Oncology
Last Update Posted:2026-10-07

Study Overview

Brief 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

Conditions

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

Intervention / Treatment

  • Drug: Palbociclib
  • Drug: Letrozole
  • Drug: Fulvestrant
  • Other: Questionnaire Administration
  • Other: Quality-of-Life Assessment

Other Study ID Numbers

  • A171601
  • NCI-2017-01596

Start Date (Actual)

2018-08-15

Primary Completion Date (Actual)

2020-09-08

Study Completion Date (Actual)

2026-02-27

Enrollment (Actual)

93

Study Type

Interventional

Phase

Phase 2