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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: Active Phase 1 study of Breast Cancer, sponsored by Genentech.
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. According to ClinicalTrials.gov, the official US trial registry.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 181 participants |
| Start Date | 2017-11-24 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 1 |
What the registry record for NCT03332797 still lists
NCT03332797 is an interventional study that assigns participants to a tested intervention. The registered 181 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (94% lower).
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 names 20 study sites across 8 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03332797's enrollment target sits among peer trials
181 405th of 1224 higher than 820 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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