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)

ClinicalTrials.gov ID: NCT07541079

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Official title

A Phase IIIb, Single-Arm, Open-Label Study Evaluating Adherence, Tolerability, and Patient Reported Outcomes (PRO) of Giredestrant in Patients With ER+/HER2- Early Breast Cancer Who Are Intolerant to Adjuvant Aromatase Inhibitor Therapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT07541079
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Genentech, Inc.; Industry
Enrollment: 300 participants

Conditions and interventions

Conditions

Early Breast Cancer

Interventions

Giredestrant Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: Female
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 25, 2026 (Actual)
Primary completion: Jun 30, 2032 (Estimated)
Completion: Jun 30, 2034 (Estimated)
Last update posted: Nov 12, 2026

2026 – 2034

United States locations

U.S. sites: 13
U.S. states: 10
U.S. cities: 13

Facility	City	State	ZIP	Site status
Clearview Cancer Institute - Huntsville	Huntsville	Alabama	35805-2606	Recruiting
Community Cancer Institute (CCI)	Clovis	California	93611-6878	Recruiting
Orange Coast Medical Center	Fountain Valley	California	92708-6728	Recruiting
Stockton Hematology Oncology Medical Group-2626 N California St	Stockton	California	95204-6019	Recruiting
Eastern CT Hematology and Oncology Associates	Norwich	Connecticut	06360-2700	Recruiting
MedStar Washington Hospital Center	Washington D.C.	District of Columbia	20010-3017	Recruiting
Cancer and Leukemia Center	Sterling Heights	Michigan	48314	Recruiting
Renown Health Conrad Breast Center at South Meadows	Reno	Nevada	89521	Recruiting
Astera Cancer Care East Brunswick	East Brunswick	New Jersey	08816-4096	Recruiting
Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey	08901-1914	Recruiting
New Mexico Oncology Hematology Consultants	Albuquerque	New Mexico	87109-4495	Recruiting
New York Oncology Hematology (Patroon) - USOR	Albany	New York	12206-5013	Recruiting
Magee Womens Hospital	Pittsburgh	Pennsylvania	15213	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07541079, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 12, 2026 · Synced Nov 12, 2026