A Study of Giredestrant (GDC-9545) in Postmenopausal Women With Stage I-III Operable, Estrogen Receptor-Positive Breast Cancer

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Genentech, Inc.
Study ID
NCT03916744
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Giredestrant — DRUG
    Giredestrant will be administered orally once daily (QD) starting on Day 1 up to and including the day of surgery (if allowed per local process) on Day 15 (+/-2 days).
  • Surgery — PROCEDURE
    Breast cancer surgery will take place on Day 15 (+/-2 days).

Study Details

This study will evaluate the pharmacodynamics, pharmacokinetics, safety, and biologic activity of giredestrant in participants with Stage I-III operable estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, untreated breast cancer.

Key Dates

Start date
Jul 26, 2019
Status verified
Mar 2023
Primary completion
May 25, 2021
Completion
May 25, 2021

Study Design

Enrollment
75 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Giredestrant 10 mg
  • Experimental: Giredestrant 30 mg
  • Experimental: Giredestrant 100 mg

Primary Outcome Measure

Change From Baseline in Tumor Cell Proliferation, as Measured by the Proportion of Nuclei Staining Ki67-Positive at Surgery Relative to Baseline in Pre- and Post-Treatment Tumor Biopsy Samples [ Time Frame: Baseline and Surgery (Day 15) ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of ColoradoAuroraColorado80045-2517-
Massachusetts General HospitalBostonMassachusetts02114-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in Aurora, CO

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Colorado· Aurora, COMassachusetts General Hospital· Boston, MAMemorial Sloan Kettering Cancer Center· New York, NY

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