CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 70 enrolled
Drug / intervention
Palbociclib +2 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/NCT02384239
NCT02384239Phase 2Completed
CompareCT.gov

Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Hormone Receptor Positive Metastatic Breast Cancer Previously Exposed to Inhibitors of the PI3K Pathway: A Phase II Study With Pharmacodynamics Markers

University of California, San Francisco·interventional·Posted Mar 10, 2015·Updated Mar 16, 2022

In Brief

A Phase 2 clinical trial evaluating Palbociclib, Tamoxifen, and 1 other intervention for Metastatic Breast Cancer and Hormone Receptor Positive. Completed, enrolled 70 participants across 9 sites.

Detailed Summary

This phase II trial studies the side effects of palbociclib when given together with fulvestrant or tamoxifen citrate in treating patients with hormone receptor positive breast cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy using fulvestrant or tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving palbociclib together with fulvestrant or tamoxifen citrate may work better in treating hormone receptor positive breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer, Hormone Receptor Positive
CountriesUnited States
CollaboratorsTranslational Breast Cancer Research Consortium, Dana-Farber Cancer Institute

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 10, 2015
Enrollment StartOct 19, 2015
Primary CompletionJan 31, 2021
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 11.3 years ago

Interventions

Palbociclibdrug

Given orally (PO)

Tamoxifendrug

Given orally (PO)

Fulvestrantdrug

Given by intramuscular (IM) injection.