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Expanded Access Program to Provide Giredestrant to Participants With ER+, HER2- Early or Locally Advanced/Metastatic Breast Cancer

NCT07643831 · Status: AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2026-06-12

No results posted yet for this study

Summary

The primary objective of this expanded access program (EAP) is to provide early access to giredestrant for participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer (eBC) or locally advanced/metastatic breast cancer (LA/mBC) prior to commercial availability in the United States.

Conditions

  • ER+/HER2- Early or Locally Advanced/Metastatic Breast Cancer

Interventions

DRUG

Giredestrant

Giredestrant 30 milligrams (mg) will be self-administered orally once a day (QD) on Days 1-28 of each 28-day cycle.

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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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 NCT07643831 on ClinicalTrials.gov