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 (NCT03332797)
A Phase Ia/Ib, Multicenter, Open-Label, Dose Escalation, Dose Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-9545 Alone or in Combination With Palbociclib and/or LHRH Agonist in Patients With Locally Advanced or Metastatic Estrogen Receptor-Positive Breast Cancer
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Colorado — Aurora, Colorado
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (23 Sites)
- University of Colorado — Aurora, Colorado
- Massachusetts General Hospital. — Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- Dana Farber Cancer Institute — Boston, Massachusetts
- Memorial Sloan Kettering Cancer Center — New York, New York
- Vanderbilt University Medical Center — Nashville, Tennessee
- St Vincent's Hospital Sydney — Darlinghurst, New South Wales
- Peter Maccallum Cancer Centre — Melbourne, Victoria
- 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,
- ICO L'Hospitalet — L'Hospitalet de Llobregat, Barcelona
- 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,
- Hospital Clinico Universitario de Valencia — Valencia,
- Barts Health NHS Trust — London,
- The Royal Marsden Hospital — Suttton,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Breast Cancer
- S0221 Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer — Anniston, Alabama
- [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer — Los Angeles, California
- Evaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery — Durham, North Carolina
- TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study B) — Palo Alto, California
- A Multi Modality Surveillance Program for Women At High Risk for Breast Cancer — Chicago, Illinois
- ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer — Duarte, California
Explore by condition: All Breast Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.