A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Pr… (NCT05896566) | Clinical Trial Compass
CompletedPhase 2
A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer
France, Germany231 participantsStarted 2024-01-23
Plain-language summary
PREcoopERA is a randomized (2:2:1), multicenter, open-label, three-arm (A, B, C), Window-of-Opportunity (WOO) trial to evaluate the activity and safety of giredestrant (A) versus giredestrant plus triptorelin (B) versus anastrozole plus triptorelin (C).
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Premenopausal women age ≥18 years, premenopausal status defined as:
Estradiol (E2) in the premenopausal range (according to institution parameters) or Patient has been menstruating regularly during the 6 months prior to screening and has not used any form of hormonal contraception or any other hormonal treatments during this time.
* Histologically confirmed, operable invasive breast carcinoma.
* Eligible for upfront breast conservative surgery or upfront mastectomy: stage I, stage II or operable stage III (excludes T4) (AJCC Cancer Staging Manual 8th edition 2017).46 Tumor size must be ≥1.0 cm Multicentric and multifocal tumors and bilateral breast cancers are allowed but investigators must ensure the same tumor foci is biopsied pre-treatment and post-treatment (e.g., via clipping of the biopsied tumor foci).
* Documented estrogen receptor (ER)-positive tumor in accordance to ASCO/CAP guidelines (Allison et al. 2020),47 assessed locally and defined as ≥1% of tumor cells stained positive.
* Documented human epidermal growth factor receptor-2 (HER2)-negative tumor in accordance to 2018 ASCO/CAP guidelines (Wolff et al. 2018)48, as determined per local assessment.
* Ki 67 ≥10% in diagnostic biopsy as determined per local assessment.
* Eastern Cooperative Oncology Group Performance Status 0-1.
* Resting heart rate ≥40 bpm.
* Normal hematologic status
* Normal renal function
* Normal liver function
* INR \<1.5× ULN and PTT \<1.5x ULN Except for patients re…
What they're measuring
1
Change in Ki 67
Timeframe: From date of randomisation until 29 ±3 days post-randomisation