Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis

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.

Conditions

• Anatomic Stage IV Breast Cancer AJCC v8
• Estrogen Receptor Positive
• HER2/Neu Negative
• Metastatic Breast Carcinoma
• Metastatic Malignant Neoplasm in the Bone
• Progesterone Receptor Positive
• Prognostic Stage IV Breast Cancer AJCC v8

Interventions

DRUG

Anastrozole

Given PO

DRUG

Exemestane

Given PO

DRUG

Fulvestrant

Given IM

DRUG

Letrozole

Given PO

DRUG

Palbociclib

Given PO

RADIATION

Radiation Therapy

Undergo radiation therapy

DRUG

Tamoxifen

Given PO

Sponsors & Collaborators

• Pfizer

  collaborator INDUSTRY

• National Cancer Institute (NCI)

  collaborator NIH

• National Institutes of Health (NIH)

  collaborator NIH

• Emory University

  lead OTHER

Principal Investigators

• Mylin Torres, MD · Emory University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-02-08

Primary Completion

2022-10-13

Completion

2022-10-13

FDA Drug

Yes

Countries

• United States

Study Locations