CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 93 enrolled
Drug / intervention
Palbociclib +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03633331
NCT03633331Phase 2Completed

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

Alliance for Clinical Trials in Oncology·interventional·Posted Aug 16, 2018·Updated Apr 29, 2026

In Brief

A Phase 2 clinical trial evaluating Palbociclib, Letrozole, and 3 other interventions for Estrogen Receptor-positive Breast Cancer and 2 related conditions. Completed, enrolled 93 participants across 447 sites.

Detailed 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. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 16, 2018
Enrollment StartAug 15, 2018
Primary CompletionSep 8, 2020
Study CompletionFeb 27, 2026
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 7.9 years ago

Interventions

Palbociclibdrug

Given PO

Letrozoledrug

Given PO

Fulvestrantdrug

Given IM

Questionnaire Administrationother

Ancillary studies

Quality-of-Life Assessmentother

Ancillary studies