Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With ER+/HER2[-] & Ki67≥10% (EMPRESS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05659563|
Recruitment Status : Recruiting
First Posted : December 21, 2022
Last Update Posted : November 18, 2023
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Breast Cancer, Early-Onset||Drug: Giredestrant Drug: Tamoxifen||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Multicenter, international, open-label, two-arms, one stage, phase II, window of opportunity, clinical trial|
|Masking:||None (Open Label)|
|Official Title:||Preoperative Window of Opportunity Study With Giredestrant (GDC-9545) or Tamoxifen in Premenopausal Women With Estrogen Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative & Ki67≥10% Early Breast Cancer|
|Actual Study Start Date :||July 20, 2023|
|Estimated Primary Completion Date :||November 2024|
|Estimated Study Completion Date :||December 2024|
Experimental: Arm A
Giredestrant (GDC-9545): 30mg, orally (PO), daily (QD) during 15 days
Giredestrant is a highly potent, non-steroidal, oral selective ER antagonist and degrader (SERD)
Other Name: GDC-9545
Active Comparator: Arm B
Tamoxifen: 20mg, orally (PO), daily (QD) during 15 days
Tamoxifen is a selective estrogen receptor (ER) modulator
Other Name: Nolvadex® or Soltamox®
- Change in proliferative index (Ki67 expression) [ Time Frame: 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)
- Complete cell cycle arrest (CCCA) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
- Changes in molecular profiles of plasma biomarkers related to endocrine function [ Time Frame: Baseline up to 15 days ]To compare the expression of blood biomarkers in samples obtained at baseline and post-therapy using a plasma endocrine panel
- Incidence and severity of adverse events [ Time Frame: Baseline up to 15 days ]To evaluate incidence and severity of adverse events, with severity determined in accordance to NCI-CTCAE v.5.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05659563
|Contact: Ana Garrido||667 762 firstname.lastname@example.org|
|Contact: Susana Vitorino||+ 34 932 214 email@example.com|
|Principal Investigator:||Antonio Llombart, MD||Arnau de Vilanova Hospital, Valencia (Spain)|