Giredestrant for Early Breast Cancer After AI Intolerance
This study is looking at giredestrant, a medication for early breast cancer, in women who have estrogen receptor-positive (ER+) and HER2-negative (HER2-) breast cancer and could not tolerate previous aromatase inhibitor (AI) therapy. The study aims to understand how well patients stick to their giredestrant treatment and how they feel while taking it. You would take giredestrant daily for up to 4.5 years. To join, you must have ER+ and HER2- early breast cancer and have found previous AI therapy difficult to tolerate. The main goals are to see how many people stop taking giredestrant within 12 months and to track any side effects.
- Study design
- This is an interventional study planning to enroll 300 participants. The phase of the study is not specified.
- What's involved
- You would take giredestrant orally once daily for up to 4.5 years, or until your disease returns or side effects become too much.
- Compensation
- Not stated in the trial record.
- Follow-up
- Side effects will be monitored from the start of the study until 28 days after your last dose of giredestrant, which could be up to 4 years and 7 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07541079
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)
Recruiting
PHASE3Ages 18+InterventionalTreatmentGenentech, Inc.
~300 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:Giredestrant
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Participants Who Have Discontinued Giredestrant for Any Reason at 12 Months
Measured over At 12 months
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Clinical Trials · STUDY_DIRECTOR · Genentech, Inc.
Who to contact
Reference Study ID Number: GO46747 https://forpatients.roche.com/ No attachments to email below.
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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
What this trial measures
- Incidence of Participants Who Have Discontinued Giredestrant for Any Reason at 12 MonthsAt 12 months
- Incidence and Severity of Adverse Events, with Severity Determined According to the National Cancer Institute Common Terminology Criteria of Adverse Events, version 6.0 (NCI CTCAE v6.0)From baseline until 28 days after the final dose of study drug (up to 4 years, 7 months)