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NCT03332797 · ClinicalTrials.gov registry record · Phase 1

A Study of GDC-9545 Alone or in Combination With Palbociclib and/or Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Locally Advanced or Metastatic Estrogen Receptor-Positive Breast Cancer

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

Active
Registry status
Phase 1
Development phase
181
Enrollment target
20
Study locations

NCT03332797 is a Phase 1 study of Breast Cancer that is active but no longer recruiting, run by Genentech. The registered enrollment target is 181 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT03332797, a Phase 1 study of Breast Cancer, is active but no longer recruiting, sponsored by Genentech.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
181 participants
Enrollment target
20
Study locations

Study Summary

This study will evaluate the safety, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of GDC-9545 as a single agent and in combination with palbociclib and/or luteinizing hormone-releasing hormone (LHRH) agonist in participants with advanced or metastatic estrogen receptor (ER)-positive (human epidermal growth factor receptor 2 \[HER2\]-negative) breast cancer.

Conditions Studied

Breast Cancer

Interventions

  • DRUG Palbociclib
  • DRUG LHRH Agonist
  • DRUG GDC-9545

Study Locations (20)

Other

  • National Cancer Center - Gyeonggi-do
  • Seoul National University Hospital - Seoul
  • Severance Hospital, Yonsei University Health System - Seoul
  • Asan Medical Center - Seoul
  • Samsung Medical Center - Seoul
  • Hospital Quiron Barcelona - Barcelona
  • Hospital Universitari Vall d'Hebron - Barcelona
  • Hospital General Universitario Gregorio Maranon - Madrid
  • Centro Oncologioco MD Anderson Internacional - Madrid
  • Hospital Universitario Ramón y Cajal - Madrid
  • Hospital Universitario HM Sanchinarro - Madrid

Massachusetts

  • Massachusetts General Hospital. - Boston
  • Beth Israel Deaconess Medical Center - Boston
  • Dana Farber Cancer Institute - Boston

Colorado

  • University of Colorado - Aurora

New York

  • Memorial Sloan Kettering Cancer Center - New York

Tennessee

  • Vanderbilt University Medical Center - Nashville

New South Wales

  • St Vincent's Hospital Sydney - Darlinghurst

Victoria

  • Peter Maccallum Cancer Centre - Melbourne

Barcelona

  • ICO L'Hospitalet - L'Hospitalet de Llobregat

Trial Details

FieldValue
Enrollment Target 181 participants
Start Date 2017-11-24
Est. Completion 2026-07-31
Phase Phase 1

Sponsor

Genentech

332 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03332797

The ClinicalTrials.gov registry entry for NCT03332797 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 181 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 (94% 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 3 interventions - of which Palbociclib is the first listed.

NCT03332797 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Other, Massachusetts, Colorado.

Frequently Asked Questions

What is clinical trial NCT03332797 about?

NCT03332797 is a clinical study titled "A Study of GDC-9545 Alone or in Combination With Palbociclib and/or Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Locally Advanced or Metastatic Estrogen Receptor-Positive Breast Cancer". This study will evaluate the safety, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of GDC-9545 as a single agent and in combination with palbociclib and/or luteinizing hormone-releasing hormone (LHRH) agonist in participants with advanced or metastatic estr...

What is the current status of trial NCT03332797?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 181 participants. The study started on 2017-11-24. Estimated completion is 2026-07-31.

What conditions does trial NCT03332797 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT03332797?

The interventions under investigation include: Palbociclib (DRUG), LHRH Agonist (DRUG), GDC-9545 (DRUG).

Who is sponsoring clinical trial NCT03332797?

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

Where is trial NCT03332797 being conducted?

This trial has 20 study locations across Colorado, Massachusetts, New York, Tennessee, New South Wales. 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 Editorial

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, or report a data error.