Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With ER+/HER2[-] & Ki67≥10%
- Conditions
- Breast CancerBreast Cancer, Early-Onset
- Interventions
- Registration Number
- NCT05659563
- Lead Sponsor
- MedSIR
- Brief 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.
- Detailed Description
This is a multicenter, international, open-label, two-arms, one stage, phase II, preoperative window of opportunity clinical trial to evaluate the efficacy of giredestrant (GDC-9545) as single agent in ER\[+\]/HER2\[-\] early breast cancer patients with Ki67 ≥ 10%.
Upon meeting all selection criteria, 92 patients enrolled in the study will receive either giredestrant (GDC-9545) 30 mg or tamoxifen .
A total of 92 patients will be enrolled as follows:
* 46 patients in the investigational Arm A will receive giredestrant \[GDC-9545\] 30 mg. It will be administered orally once a day during 15 days.
* 46 patients in the control Arm B will receive tamoxifen 20 mg. It will be administered orally once a day during 15 days.
Patients can take both treatments at home.
The main objective is to analyze the efficacy of giredestrant (GDC-9545) according to changes in tumor cell proliferation. This analysis will compare absolute changes for Ki67 expression between baseline score and the evaluation after 15 days of treatment.
Total study duration is 15 days of treatment and until 28 days after the last dose of the study treatment (or discontinuation) of follow up.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 92
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B Tamoxifen Tamoxifen: 20mg, orally (PO), daily (QD) during 15 days Arm A Giredestrant Giredestrant (GDC-9545): 30mg, orally (PO), daily (QD) during 15 days
- Primary Outcome Measures
Name Time Method Change in proliferative index (Ki67 expression) Baseline up to 15 days To assess changes in tumor cell proliferation as measured by Ki67 expression between baseline and D15 (+1 day) post-treatment tumor biopsy samples by central assessment in patients with centrally confirmed Ki67 ≥10% (Arm A: giredestrant vs Arm B: tamoxifen)
- Secondary Outcome Measures
Name Time Method Complete cell cycle arrest (CCCA) Baseline up to 15 days To measure complete cell cycle arrest in all arms, defined as the percentage of participants with centrally assessed Ki67 scores ≤2.7% stained nuclei upon treatment
Changes in molecular profiles of tumor tissue samples Baseline up to 15 days To analyze gene expression profiles in tumor tissue samples obtained at baseline and after treatment using the HTG EdgeSeq Oncology Biomarker Panel
Changes in expression levels of estrogen receptor and progesterone receptor in tumor tissue samples Baseline up to 15 days To analyze the expression of estrogen receptor and progesterone receptor in tumor tissue samples obtained at baseline and post-therapy
Trial Locations
- Locations (18)
Hôpital Tenon AP-HP
🇫🇷Paris, France
Hopital Europeen Georges Pompidou
🇫🇷Paris, France
Institut Català d' Oncologia Badalona
🇪🇸Badalona, Barcelona, Spain
Hospital Universitari Sant Joan de Reus
🇪🇸Reus, Tarragona, Spain
Hospital General Universitario Dr. Balmis
🇪🇸Alicante, Spain
Hospital Clínic i Provincial de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitari Dexeus
🇪🇸Barcelona, Spain
Hospital Universitario Reina Sofía
🇪🇸Cordoba, Spain
Hospital Universitario Clínico San Cecilio de Granada
🇪🇸Granada, Spain
Hospital Universitario de León
🇪🇸León, Spain
Hospital Beata Maria Ana
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
🇪🇸Murcia, Spain
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain
Hospital Arnau de Vilanova de Valencia
🇪🇸Valencia, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Instituto Valenciano de Oncología
🇪🇸Valencia, Spain