A Study Evaluating Adherence, Tolerability, and Patient Reported Outcomes of Giredestrant in Part… (NCT07541079) | Clinical Trial Compass
Not Yet RecruitingPhase 3
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)
300 participantsStarted 2026-06-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is specifically for people who couldn't tolerate aromatase inhibitors, would you say my experience with those side effects fits the kind of intolerance this study is looking for?
2This is a Phase 3 trial that hasn't started enrolling yet — given that timing, is it realistic for me to wait to see if I qualify, or should we be moving forward with another treatment plan now?
3The study is tracking how many people stop taking giredestrant within 12 months — what does that tell us about how confident researchers currently are that people can actually stay on this drug long-term?
4Since the trial is measuring side effects using a formal grading system, what kinds of adverse events have been seen with giredestrant in earlier studies that I should know about before considering this?
5If this trial ends up not being available to me, either because it hasn't opened yet or I don't meet the criteria, what are the other options for managing ER+/HER2- early breast cancer if aromatase inhibitors aren't something I can tolerate?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Participants Who Have Discontinued Giredestrant for Any Reason at 12 Months
Timeframe: At 12 months
2
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)
Timeframe: From baseline until 28 days after the final dose of study drug (up to 4 years, 7 months)
Trial details
NCT IDNCT07541079
SponsorGenentech, Inc.
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2032-06-30
Contact for this trial
Reference Study ID Number: GO46747 https://forpatients.roche.com/ No attachments to email below.