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

Status:	Recruiting
Conditions:	Breast Cancer, Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	2/1/2019
Start Date:	August 17, 2017
End Date:	December 1, 2019
Contact:	Eisai Medical Information
Email:	esi_oncmedinfo@eisai.com
Phone:	1-888-274-2378

A Phase I-II 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

The purpose of phase 1 is to determine safety, tolerability and pharmacokinetics (PK) of
H3B-6545 in women with locally advanced or metastatic estrogen receptor-positive, human
epidermal growth factor 2 (HER2)-negative breast cancer.

The purpose of phase 2 is to estimate the efficacy of H3B-6545 in terms of response rate,
duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), and
overall survival (OS).

Inclusion Criteria:

1. Pre- or post-menopausal women.

2. ER-positive, HER2-negative breast cancer that is advanced or metastatic.

3. Progressed on prior therapy. Multiple prior lines of therapy allowed in Phase 1 and 2.

4. Must be willing to undergo a biopsy prior to treatment and on Cycle 2 Day 1.

5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

6. Adequate bone marrow and organ function.

Exclusion Criteria:

1. Participant with bone-only disease (Phase I only). Note: Phase II subjects may have
predominantly lytic bone only disease.

2. Participant with inflammatory breast cancer.

3. Participant has received more than one prior chemotherapy regimen for metastatic
disease (Phase II only).

4. Females of childbearing potential who are unable or unwilling to follow adequate
contraceptive measures.

We found this trial at

sites

Massachusetts General Hospital

185 Cambridge Street
Boston, Massachusetts 02114

617-724-5200