Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer

Completed · Phase 1/Phase 2

Conditions studied: Breast Neoplasms, Breast Cancer, Estrogen-receptor Positive Breast Cancer, Cancer, Breast, Breast Cancer Female, Breast Adenocarcinoma, Estrogen Receptor Positive Tumor, ER Positive

In brief

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).

Key facts

Study ID

NCT03250676

Run by

Eisai Inc.

People needed

151

Starts

2017-08-23

Expected to finish

2023-10-26

Last updated by the study team

2025-02-25

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Pre- or post-menopausal women.
• ER-positive, HER2-negative breast cancer that is advanced or metastatic.
• Progressed on prior therapy. Multiple prior lines of therapy allowed in Phase 1 and 2. Participants under amendment 6 (or subsequent amendments) must have received prior cyclin-dependent kinase (CDK4/6) inhibitor therapy. Up to one prior chemotherapy in the metastatic setting is allowed.
• A recent archival tumor tissue obtained within 6 months prior to enrollment or a fresh tumor biopsy must be provided. A second biopsy after initiating trial therapy is not required.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
• Adequate bone marrow and organ function.
• Participants under amendment 6 (or subsequent amendments) must have measurable disease at baseline as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
• Participants under amendment 6 (or subsequent amendments) must have ESR1 Y537S mutation in absence of ESR1 D538G mutation as per the results of a central laboratory from a Nucleic Acids Whole Blood sample.

You may not qualify if…

• Participants must have at least one measurable lesion.
• Participant with inflammatory breast cancer.
• Participant has received more than one prior chemotherapy regimen for metastatic disease (Phase 2 only).
• Females of childbearing potential who are unable or unwilling to follow adequate contraceptive measures.

Where it is running

• Western Regional Medical Center, Inc., DBA Cancer Treatment Centers of America, Phoenix — Goodyear, Arizona, United States
• University of California Los Angeles — Los Angeles, California, United States
• University of California San Francisco — San Francisco, California, United States
• University of Colorado - Cancer Center — Aurora, Colorado, United States
• Holy Cross Hospital Inc — Fort Lauderdale, Florida, United States
• Florida Cancer Specialists South — Fort Myers, Florida, United States
• Florida Cancer Specialists and Research Institute — Sarasota, Florida, United States
• Florida Cancer Specialists North — St. Petersburg, Florida, United States
• Southeastern Regional Medical Center, Inc., DBA Cancer Treatment Centers of America, Atlanta — Newnan, Georgia, United States
• Carle Cancer Center — Urbana, Illinois, United States
• Midwestern Regional Medical Center, Inc., DBA Cancer Treatment Centers of Americal, Chicago — Zion, Illinois, United States
• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Saint Luke's Cancer Institute — Kansas City, Missouri, United States
• Research Medical Center — Kansas City, Missouri, United States
• Comprehensive Cancer Center of Nevada — Las Vegas, Nevada, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Tennessee Oncology — Nashville, Tennessee, United States
• Parkland Health and Hospital System — Dallas, Texas, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• Tyler Oncology/Oncology PA — Tyler, Texas, United States
• Huntsman Cancer Institute at The University of Utah — Salt Lake City, Utah, United States
• Edog - Ico - Ppds — Angers, France
• Hopital Jean Minjoz — Besançon, France

Full record on ClinicalTrials.gov

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