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 range18 Years
SexFEMALE
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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.
✓. 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).
. 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.