Giredestrant in ER-positive, HER2-negative early breast cancer: who tolerates it and sticks with treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial investigates the tolerability and adherence of giredestrant in two cohorts of early breast cancer patients who are ER-positive and HER2-negative. Cohort A includes a broad upfront population across risk levels, while Cohort B includes patients who completed adjuvant CDK4/6 inhibitor therapy and endocrine treatment and are switching to giredestrant monotherapy. The study collects patient-reported outcomes to understand the impact on quality of life alongside safety and treatment continuity. Eligible participants have early-stage disease (Stage I-III), adequate organ function, and supportive use of a luteinizing hormone-releasing hormone agonist for premenopausal or perimenopausal women. Prior giredestrant exposure is exclusionary.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically confirmed diagnosis of ER-positive, HER2-negative, Stage I-III, breast cancer
* Definitive surgery of primary breast tumor(s) and axillary lymph nodes (axillary lymph node dissection and/or sentinel lymph node biopsy)
* Participants must have completed any prior adjuvant chemotherapy before enrollment, if given
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2
* Adequate organ function
* Men and pre- or perimenopausal women must receive a concurrent approved luteinizing hormone-releasing hormone agonist

Exclusion Criteria:

* Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required
* Diagnosis of inoperable locally advanced or Stage IV breast cancer
* History of any prior (ipsilateral and/or contralateral) invasive breast cancer or ductal carcinoma in situ (DCIS)
* Planned surgery during the study
* Prior treatment with giredestrant, selective estrogen receptor degraders (SERDs), or investigational endocrine agents
* Active cardiac disease or history of cardiac dysfunction

Where it's running

• CHU de Québec - Hôpital du Saint-Sacrement
  Québec, Quebec, Canada Recruiting

Study contacts

• Study coordinator: Reference Study ID Number: BO46775 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. Only)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.