Study Summary
This trial will test the effectiveness of a new drug, H3B-6545, for women with a certain type of breast cancer.
- Breast Cancer
- Estrogen Receptor Positive
- Estrogen Receptor-positive Breast Cancer
- Estrogen Receptor Positive Tumor
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
2 Primary · 9 Secondary · Reporting Duration: Phase 1 and 2 up to approximately 36 months
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
2 Treatment Groups
H3B-6545 Arm 1: Dose escalation
1 of 2
H3B-6545 Arm 2: Phase 2
1 of 2
Experimental Treatment
206 Total Participants · 2 Treatment Groups
Primary Treatment: H3B-6545 · No Placebo Group · Phase 1 & 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · Female Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Tennessee | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
- Furman, Craig, Xiaoling Puyang, Zhaojie Zhang, Zhenhua J. Wu, Deepti Banka, Kiran B. Aithal, Lee A. Albacker, et al.. 2022. “Covalent Erα Antagonist H3B-6545 Demonstrates Encouraging Preclinical Activity in Therapy-resistant Breast Cancer”. Molecular Cancer Therapeutics. American Association for Cancer Research (AACR). doi:10.1158/1535-7163.mct-21-0378.
- Furman C, Puyang X, Zhang Z, Wu ZJ, Banka D, Aithal KB, Albacker LA, Hao MH, Irwin S, Kim A, Montesion M, Moriarty AD, Murugesan K, Nguyen TV, Rimkunas V, Sahmoud T, Wick MJ, Yao S, Zhang X, Zeng H, Vaillancourt FH, Bolduc DM, Larsen N, Zheng GZ, Prajapati S, Zhu P, Korpal M. Covalent ERalpha Antagonist H3B-6545 Demonstrates Encouraging Preclinical Activity in Therapy-Resistant Breast Cancer. Mol Cancer Ther. 2022 Jun 1;21(6):890-902. doi: 10.1158/1535-7163.MCT-21-0378.
- 2017. "Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03250676.
Frequently Asked Questions
Could you please tell me how many hospitals are participating in this study?
"At the moment, this clinical trial is taking place at 17 medical facilities. Some of these are in Sarasota, Los Angeles and Goodyear with the remaining 14 centres located elsewhere. If you decide to participate in this research project, it would be best to select a location close to you to limit travel time and disruptions." - Anonymous Online Contributor
Are new patients being accepted into the trial at this time?
"No, this specific trial is not recruiting patients right now. The clinical study was first posted on August 17th, 2017 and was last updated over 2 years ago on June 29th, 2022. Having said that, there are 2715 other trials with open recruitment at the moment." - Anonymous Online Contributor