Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer
Public ClinicalTrials.gov record NCT03250676. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1-2 Multicenter, Open Label Trial of H3B-6545, a Covalent Antagonist of Estrogen Receptor Alpha, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary purpose of phase 1 portion of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of H3B-6545 in women with locally advanced or metastatic estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative breast cancer. The primary purpose of phase 2 portion of this study is to estimate the efficacy of H3B-6545 in terms of best overall response rate, duration of response (DoR), clinical benefit rate (CBR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) in all participants with ER-positive, HER2-negative breast cancer and in those with and without ER alpha mutation (including a clonal estrogen receptor 1 gene \[ESR1\] Y537S mutation).
Study identification
- NCT ID
- NCT03250676
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 151 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 22, 2017
- Primary completion
- Oct 25, 2023
- Completion
- Oct 25, 2023
- Last update posted
- Feb 24, 2025
2017 – 2023
United States locations
- U.S. sites
- 23
- U.S. states
- 15
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Western Regional Medical Center, Inc., DBA Cancer Treatment Centers of America, Phoenix | Goodyear | Arizona | 85338 | — |
| University of California Los Angeles | Los Angeles | California | 90404 | — |
| University of California San Francisco | San Francisco | California | 94158 | — |
| University of Colorado - Cancer Center | Aurora | Colorado | 80045 | — |
| Holy Cross Hospital Inc | Fort Lauderdale | Florida | 33308 | — |
| Florida Cancer Specialists South | Fort Myers | Florida | 33901 | — |
| Florida Cancer Specialists and Research Institute | Sarasota | Florida | 34232 | — |
| Florida Cancer Specialists North | St. Petersburg | Florida | 33705 | — |
| Southeastern Regional Medical Center, Inc., DBA Cancer Treatment Centers of America, Atlanta | Newnan | Georgia | 30265 | — |
| Carle Cancer Center | Urbana | Illinois | 61801 | — |
| Midwestern Regional Medical Center, Inc., DBA Cancer Treatment Centers of Americal, Chicago | Zion | Illinois | 60099 | — |
| Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Saint Luke's Cancer Institute | Kansas City | Missouri | 64111 | — |
| Research Medical Center | Kansas City | Missouri | 64132 | — |
| Comprehensive Cancer Center of Nevada | Las Vegas | Nevada | 89169 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | — |
| Tennessee Oncology | Nashville | Tennessee | 37203 | — |
| Parkland Health and Hospital System | Dallas | Texas | 75235 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Tyler Oncology/Oncology PA | Tyler | Texas | 75701 | — |
| Huntsman Cancer Institute at The University of Utah | Salt Lake City | Utah | 84112 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03250676, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 24, 2025 · Synced Sep 27, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03250676 live on ClinicalTrials.gov.