Expanded Access Program to Provide Giredestrant to Participants With ER+, HER2- Early or Locally … (NCT07643831) | Clinical Trial Compass
AVAILABLENot Applicable
Expanded Access Program to Provide Giredestrant to Participants With ER+, HER2- Early or Locally Advanced/Metastatic Breast Cancer
Plain-language summary
The primary objective of this expanded access program (EAP) is to provide early access to giredestrant for participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer (eBC) or locally advanced/metastatic breast cancer (LA/mBC) prior to commercial availability in the United States.
Who can participate
Age range
18 Years
Sex
ALL
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
. Postmenopausal status, as defined by at least one of the following criteria: Amenorrhea for ≥12 continuous months with no identified cause other than menopause. If clinically justified or if there is any doubt of postmenopausal state, a high blood follicle-stimulating hormone level in the postmenopausal range may be used to confirm a postmenopausal state in participants who are not using hormonal contraception or hormonal replacement therapy. Further guidance for these exceptional circumstances is provided in "Recommendations related to contraception and pregnancy testing in clinical trials" (CTFG 2020). Documented bilateral oophorectomy (≥14 days prior to first treatment on Day 1 of Cycle 1 and recovery from surgery to baseline), hysterectomy, or bilateral salpingectomy.
. Premenopausal or perimenopausal status, as defined by not meeting the above criteria for postmenopausal status.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
Trial details
NCT IDNCT07643831
SponsorGenentech, Inc.
Sponsor typeINDUSTRY
Study typeEXPANDED_ACCESS
Contact for this trial
Reference Study ID Number: AL46901 https://forpatients.roche.com/ No attachments to email below.