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A Study Evaluating Adherence, Tolerability, and Patient Reported Outcomes of Giredestrant in Participants With ER+/HER2- Early Breast Cancer Who Are Intolerant to Adjuvant Aromatase Inhibitor Therapy (novERA Breast Cancer)

NCT07541079 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-05-22

No results posted yet for this study

Summary

The purpose of this study is to understand treatment adherence and patient-reported outcomes of switching to giredestrant due to prior aromatase inhibitor (AI) intolerance. Giredestrant will be administered as adjuvant endocrine therapy for participants with low-, medium-, and high-risk, Stage I-III, histologically confirmed, estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), early breast cancer (eBC), as defined by the investigator. Participants will enroll if considered to be intolerant to a prior adjuvant AI therapy.

Conditions

  • Early Breast Cancer

Interventions

DRUG

Giredestrant

Participants will receive giredestrant at a dose of 30 mg orally once daily on Days 1-28 of each 28-day cycle for up to 4.5 years or until disease recurrence or unacceptable toxicity (whichever occurs first).

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Genentech, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2032-06-30
Completion
2034-06-30
FDA Drug
Yes

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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 NCT07541079 on ClinicalTrials.gov