Study on Anastrozole and Palbociclib for Treating Metastatic HER2-Negative Breast Cancer

Sponsor: Wake Forest University Health Sciences

Sponsor score: 60

ClinicalTrials ID:NCT02942355

Provider View

This clinical trial is exploring the safety and feasibility of using a combination of anastrozole and palbociclib to treat postmenopausal women with HR-positive, HER2-negative metastatic breast cancer. The study includes two groups: one receiving the treatment as the first therapy and another as maintenance after initial chemotherapy.

Patient Parameters

Program Overview

The study aims to evaluate the safety and practicality of combining anastrozole and palbociclib in treating postmenopausal women with HR-positive, HER2-negative metastatic breast cancer. It includes two groups: one receiving the treatment as the first therapy and another as maintenance after initial chemotherapy. Premenopausal women can participate if they receive an LHRH agonist. Participants will be assigned to one of the two groups after providing informed consent and meeting eligibility criteria.

Description

This study will enroll 40 women over 18-24 months, with 25 in the first therapy group and 15 in the maintenance group. Participants will be recruited from Levine Cancer Institute locations and referrals. Only women are eligible, as breast cancer in men is rare and the treatment's effectiveness in males is limited. Children are not included due to unknown effects of palbociclib in younger populations. Participants must meet specific criteria, including age, menopausal status, and cancer characteristics, to join the study.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 or older who are postmenopausal or willing to take an LHRH agonist if premenopausal.
  • Diagnosed with HR-positive, HER2-negative metastatic breast cancer.
  • No previous treatment for metastatic disease for the first therapy group.
  • For the maintenance group, must have had a positive response to first-line chemotherapy for metastatic disease.
  • Must have measurable disease or specific bone-only disease.
  • Must provide a tumor tissue sample.
  • Must have good overall health and organ function.
  • Must be able to swallow oral medication.
  • Must understand and agree to sign informed consent.

Exclusion Criteria

  • Previous treatment with any CDK inhibitor.
  • Active or uncontrolled brain metastases or related conditions.
  • Use of certain medications that affect drug metabolism.
  • Recent major surgery or cancer treatment.
  • Recent serious heart or blood vessel issues.
  • Digestive issues affecting medication absorption.
  • Previous stem cell or bone marrow transplant.
  • Allergy to anastrozole.
  • HIV infection.
  • Other serious medical or psychiatric conditions.
  • Participation in other drug studies recently.

Locations

FACILITYZIPCITYSTATE
Levine Cancer Institute28204CharlotteNorth Carolina

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