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NCT03916744 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Breast Cancer, sponsored by Genentech.

Completed
Registry status
Phase 1
Development phase
75
Enrollment target
15
Study locations

NCT03916744: Completed Phase 1 study of Breast Cancer, sponsored by Genentech.

NCT03916744 is a Phase 1 study of Breast Cancer that has completed, run by Genentech. The registered enrollment target is 75 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 15 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03916744, a Phase 1 study of Breast Cancer, has completed, sponsored by Genentech.

COMPLETED
Registry status
Phase 1
Development phase
75 participants
Enrollment target
15
Study locations

Study Summary

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.

Conditions Studied

Interventions

  • PROCEDURE Surgery
  • DRUG Giredestrant

Study Locations (15)

Other

  • Clinique Edith Cavell; Pharmacie - Auderghem
  • UZ Antwerpen - Edegem
  • Clinique Sainte-Elisabeth; Oncologie - Namur
  • Hospital Universitari Vall d'Hebron - Barcelona
  • Hospital Ruber Internacional;Servicio de Oncologia - Madrid
  • HM Sanchinarro ? CIOCC - Madrid
  • Hospital Clinico Universitario de Valencia - Valencia
  • Barts Health NHS Trust; William Harvey Heart Centre, QMUL School of Medicine & Dentistry - London
  • Royal Cornwall Hospital - Truro

Colorado

  • University of Colorado - Aurora

Massachusetts

  • Massachusetts General Hospital - Boston

New York

  • Memorial Sloan Kettering Cancer Center - New York

New South Wales

  • St Vincent's Hospital Sydney - Darlinghurst

Victoria

  • Sunshine Hospital - St Albans

Guipuzcoa

  • Onkologikoa - Instituto Oncológico de Donostia - Donostia / San Sebastian

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2019-07-26
Est. Completion 2021-05-25
Phase Phase 1

Sponsor

Genentech

332 total trials

What the Registry Record Tells You About NCT03916744

The ClinicalTrials.gov registry entry for NCT03916744 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Surgery is the first listed.

NCT03916744 reports 15 study locations spanning 7 distinct geographic areas - top geographies include Other, Colorado, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT03916744 about?

NCT03916744 is a clinical study titled "A Study of Giredestrant (GDC-9545) in Postmenopausal Women With Stage I-III Operable, Estrogen Receptor-Positive Breast Cancer". 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.

What is the current status of trial NCT03916744?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2019-07-26. Estimated completion is 2021-05-25.

What conditions does trial NCT03916744 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT03916744?

The interventions under investigation include: Surgery (PROCEDURE), Giredestrant (DRUG).

Who is sponsoring clinical trial NCT03916744?

This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03916744 being conducted?

This trial has 15 study locations across Colorado, Massachusetts, New York, New South Wales, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.