Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With … (NCT05659563) | Clinical Trial Compass
CompletedPhase 2
Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With ER+/HER2[-] & Ki67≥10%
France, Spain92 participantsStarted 2023-07-20
Plain-language summary
This study is a window of opportunity clinical trial to evaluate the efficacy of giredestrant (GDC-9545) or tamoxifen in estrogen receptor-positive (ER\[+\])/human epidermal growth factor receptor 2-negative (HER2\[-\]) primary invasive adenocarcinoma of the breast with Ki67 level ≥ 10%.
A total of 92 patients will be enrolled in this trial and randomized 1:1 in the arm A with giredestrant (GDC-9545) and the arm B with tamoxifen, with a total duration of treatment of 15 days.
This study will analyze the efficacy of giredestrant (GDC-9545) as determined by Ki67 expression between baseline tumor biopsy samples and post-treatment biopsy samples.
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
. Signed Informed Consent Form (ICF) prior to beginning specific protocol procedures.
. Aged ≥ 18 years at time of signing ICF.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
. Women in a well-determined premenopausal status as indicated in the protocol Section 4.1.
. Histologically confirmed invasive breast carcinoma, with all the following characteristics:
. Documented ER-positive tumor in accordance with American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines (Allison et al., 2020), assessed locally and defined as ≥ 1% of tumor cells stained positive.
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.
1This trial compared giredestrant and tamoxifen in premenopausal women before surgery — since it's now completed, has any data been published yet, and what did the results show about whether either drug actually lowered Ki67 levels in tumors like mine?
2The trial specifically required a Ki67 of 10% or higher, which signals a more actively dividing tumor — does my tumor's Ki67 score put me in a similar category, and does that affect which treatment approach you'd recommend for me?
3Because this was a Phase 2 'window of opportunity' study given for a short period before surgery, what do the findings tell us about how well giredestrant works compared to tamoxifen, and does that influence the options you'd consider for my treatment plan?
4Giredestrant is still an investigational drug — are there other trials or standard treatment pathways involving tamoxifen or other hormone therapies that might be more appropriate for me as a premenopausal woman with ER-positive, HER2-negative breast cancer?
5Since this study measured Ki67 changes as its main outcome rather than long-term survival, how useful is that kind of result when we're thinking about what's actually best for my situation, and should it factor into the decisions we're making together?
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.
. Documented HER2-negative tumor in accordance with 2018 ASCO/CAP guidelines (Wolff et al., 2018), assessed locally at baseline.
. Ki67 score ≥10% analyzed locally and centrally confirmed (Nielsen et al., 2021).
Exclusion criteria
. Patients will be excluded from the study if they meet ANY of the following criteria:
. Progesterone receptor (PgR)\[+\] and ER\[-\] patients.
. Patients who have history of any prior (ipsilateral and/or contralateral) invasive BC or Ductal carcinoma in situ (DCIS). Participants with a history of contralateral DCIS treated by only local regional therapy at any time may be eligible.
. Evidence of metastatic disease.
. Previous systemic or local treatment for the primary BC currently under investigation.
. History of any prior treatment with chemotherapy drugs, aromatase inhibitors (AIs), tamoxifen, selective estrogen receptor down regulator, or cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i).
. Any invasive malignancy diagnosed within the previous 5 years prior to screening in this study (other than basal cell carcinoma, cervical carcinoma in situ or contralateral DCIS).
. Known issues with swallowing oral medication, or inability or unwillingness to swallow oral medication.