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Stereotactic Radiosurgery With Abemaciclib, Ribociclib, or Palbociclib in Treating Patients With Hormone Receptor Positive Breast Cancer With Brain Metastases

NCT04585724 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-10-18

No results posted yet for this study

Summary

This phase I trial studies the side effects of stereotactic radiosurgery with abemaciclib, ribociclib, or palbociclib in treating patients with hormone receptor positive breast cancer that has spread to the brain (brain metasteses). Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Abemaciclib, ribociclib, and palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving abemaciclib, ribociclib, or palbociclib concurrently with stereotactic radiosurgery may reduce the side effects and/or increase the response to each of the therapies.

Conditions

  • Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
  • Metastatic Breast Carcinoma
  • Metastatic Malignant Neoplasm in the Brain
  • Prognostic Stage IV Breast Cancer AJCC v8

Interventions

DRUG

Abemaciclib

Given PO

DRUG

Palbociclib

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

DRUG

Ribociclib

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Jim Zhong · Emory University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-12
Primary Completion
2021-09-13
Completion
2021-09-13
FDA Drug
Yes

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04585724 on ClinicalTrials.gov