Giredestrant after aromatase inhibitor intolerance in early ER+/HER2- breast cancer

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 is a Phase 3 interventional trial evaluating adherence, tolerability, and patient-reported outcomes after switching to giredestrant as adjuvant endocrine therapy in adults with ER+/HER2- early breast cancer who are intolerant to prior AI therapy. Eligible participants have Stage I–III disease, are postmenopausal, and have documented AI intolerance with ongoing AI-related adverse events. The study assesses how well patients adhere to giredestrant, the side effect profile, and patient-reported quality of life and symptoms over time. Giredestrant is given as the adjuvant endocrine therapy option for participants at risk of recurrence according to investigator assessment. Safety and efficacy signals will be interpreted in the context of tolerability and patient experience.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Considered appropriate for treatment with endocrine therapy (ET)
* Histologically confirmed diagnosis of ER+/HER2-, Stage I-III (low-/medium-/high-risk) early breast cancer (eBC)
* Documented ER+ tumor according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP), defined as ≥1% of tumor cells stained positive
* Documented HER2- tumor according to ASCO/CAP
* Postmenopausal females at the time of signing the Informed Consent Form
* Documented use of a prior adjuvant aromatase inhibitor (AI) (i.e., anastrozole, exemestane, or letrozole) for a total of ≥6 months
* Documented use of an adjuvant AI (i.e., anastrozole, exemestane, or letrozole) for the consecutive ≥3 months immediately prior to consent
* Participant and investigator agree that current symptoms on AI are intolerable and warrant a switch in therapy to attempt sustained treatment
* Documented Grade 2 or 3 adverse events, per NCI CTCAE v6.0, determined by the investigator to be associated with AI therapy's intolerance
* Participant and investigator planning the first switch from an AI
* Has completed the following: (neo)adjuvant chemotherapy (if administered), definitive surgery of primary breast tumor(s) and/or axillary lymph nodes dissection (ALND) and/or sentinel lymph node biopsy (SLNB) and/or radiotherapy
* Eastern Cooperative Oncology Group Performance (ECOG) Performance Status 0 or 1

Exclusion Criteria:

* Participation within 6 months before enrollment in any other clinical study involving an investigational adjuvant treatment including anti-cancer agents
* Diagnosis of rheumatoid arthritis, psoriatic arthritis, or other inflammatory connective tissue disease
* Any prior fulvestrant or any oral selective estrogen receptor degraders (SERDs)
* Have active cardiac disease or history of cardiac dysfunction
* Have clinically significant liver disease consistent with Child-Pugh Class B or C, including active hepatitis (e.g., hepatitis B virus \[HBV\] or hepatitis C virus \[HCV\]), current alcohol abuse, cirrhosis, or positive test for viral hepatitis
* Treatment with strong CYP3A inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment
* Have had any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study

Where it's running

• Orange Coast Medical Center
  Fountain Valley, California, United States Recruiting
• Stockton Hematology Oncology Medical Group-2626 N California St
  Stockton, California, United States Recruiting
• MedStar Washington Hospital Center
  Washington D.C., District of Columbia, United States Recruiting
• Cancer and Leukemia Center
  Sterling Heights, Michigan, United States Recruiting
• Renown Health Conrad Breast Center at South Meadows
  Reno, Nevada, United States Recruiting
• Astera Cancer Care East Brunswick
  East Brunswick, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Reference Study ID Number: GO46747 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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Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.