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

NCT05659563 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-03-19

Study results available
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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.

Conditions

Interventions

DRUG

Giredestrant

Giredestrant is a highly potent, non-steroidal, oral selective ER antagonist and degrader (SERD)

DRUG

Tamoxifen

Tamoxifen is a selective estrogen receptor (ER) modulator

Sponsors & Collaborators

  • MedSIR

    lead OTHER

Principal Investigators

  • Antonio Llombart, MD · Arnau de Vilanova Hospital, Valencia (Spain)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-20
Primary Completion
2025-01-30
Completion
2025-01-30

Countries

  • France
  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05659563 on ClinicalTrials.gov