CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
Anastrozole +6 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/NCT03691493
NCT03691493Phase 2Completed

A Phase II Multi-Institutional Study of Concurrent Radiotherapy, Palbociclib, and Hormone Therapy for Treatment of Bone Metastasis in Breast Cancer Patients

Emory University·interventional·Posted Oct 1, 2018·Updated Feb 17, 2025

In Brief

A Phase 2 clinical trial evaluating Anastrozole, Exemestane, and 5 other interventions for Anatomic Stage IV Breast Cancer AJCC v8 and 6 related conditions. Completed, enrolled 36 participants across 10 sites.

Detailed Summary

This phase II trial studies how well radiation therapy given with standard care palbociclib and hormone therapy work in treating patients with breast cancer that has spread from one part of the body to the bone. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Antihormone therapy, such as fulvestrant, letrozole, anastrozole, exemestane, or tamoxifen, may lessen the amount of estrogen made by the body. Giving radiation therapy, palbociclib, and hormone therapy may work better in treating breast cancer patients with bone metastasis.

Study Details

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedOct 1, 2018
Enrollment StartFeb 8, 2019
Primary CompletionOct 13, 2022
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 7.8 years ago

Interventions

Anastrozoledrug

Given PO

Exemestanedrug

Given PO

Fulvestrantdrug

Given IM

Letrozoledrug

Given PO

Palbociclibdrug

Given PO

Radiation Therapyradiation

Undergo radiation therapy

Tamoxifendrug

Given PO