Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With ER+/HER2[-] & Ki67≥10%

Sponsor
MedSIR
Study ID
NCT05659563
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Giredestrant — DRUG
    Giredestrant is a highly potent, non-steroidal, oral selective ER antagonist and degrader (SERD)
  • Tamoxifen — DRUG
    Tamoxifen is a selective estrogen receptor (ER) modulator

Study Details

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.

Key Dates

Start date
Jul 20, 2023
Status verified
Feb 2026
Primary completion
Jan 30, 2025
Completion
Jan 30, 2025

Study Design

Enrollment
92 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Giredestrant (GDC-9545): 30mg, orally (PO), daily (QD) during 15 days
  • Active Comparator: Arm B
    Tamoxifen: 20mg, orally (PO), daily (QD) during 15 days

Primary Outcome Measure

Change in Proliferative Index (Ki67 Expression) [ Time Frame: Baseline up to 15 days ]

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