ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03250676
Recruitment Status : Recruiting
First Posted : August 16, 2017
Last Update Posted : October 15, 2018
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Eisai Inc. ( H3 Biomedicine Inc. )

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Breast Neoplasms Breast Cancer Estrogen-receptor Positive Breast Cancer Cancer, Breast Breast Cancer Female Breast Adenocarcinoma Estrogen Receptor Positive Tumor ER Positive Drug: H3B-6545 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 17, 2017
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Estrogens

Arm Intervention/treatment
Experimental: H3B-6545 Arm 1: Dose escalation Drug: H3B-6545
Oral capsules by mouth once daily

Experimental: H3B-6545 Arm 2: Phase 2 Drug: H3B-6545
Oral capsules by mouth once daily




Primary Outcome Measures :
  1. Number of Participants with Dose-limiting Toxicities (DLTs) [ Time Frame: Phase 1 Cycle 1 (28 days) ]
  2. Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Phase 1 and 2 continuously throughout the study until 28 days after treatment discontinuation (up to 36 months) ]

Secondary Outcome Measures :
  1. Area under the Plasma Concentration-time Curve from Time 0 Through the Last Measurable Point (AUC0-t) of H3B-6545 [ Time Frame: Phase 1, Cycle 1 (28-day cycles): Days 1 and 15 pre-dose and at multiple time points (up to 24 hours) post-dose; or Phase 2 Cycle 1 (28-day cycles): Days 15 or 22 pre-dose and at multiple time points (up to 24 hours) post-dose ]
  2. Mean Maximum Observed Plasma Concentration (Cmax) of H3B-6545 [ Time Frame: Phase 1, Cycle 1 (28-day cycles): Days 1 and 15 (pre-dose and at multiple time points (up to 24 hours) post-dose; or Phase 2 Cycle 1 (28-day cycles): Days 15 or 22 pre-dose and at multiple time points (up to 24 hours) post-dose ]
  3. Time of Maximum Observed Plasma Concentration (tmax) of H3B-6545 [ Time Frame: Phase 1, Cycle 1 (28-day cycles): Days 1 and 15 pre-dose and at multiple time points (up to 24 hours) post-dose; or Phase 2 Cycle 1 (28-day cycles): Days 15 or 22 pre-dose and at multiple time points (up to 24 hours) post-dose ]
  4. Duration of Response (DoR) [ Time Frame: Phase 1 and 2 up to approximately 36 months ]
  5. Disease Control Rate (DCR) [ Time Frame: Phase 1 and 2 up to approximately 36 months ]
  6. Progression-free survival (PFS) [ Time Frame: Phase 1 and 2 up to approximately 36 months ]
  7. Overall Survival (OS) [ Time Frame: Phase 1 and 2 up to approximately 36 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03250676


Contacts
Contact: Eisai Medical Information 1-888-274-2378 esi_medinfo@eisai.com

Locations
United States, Florida
Florida Cancer Specialists and Research Institute Recruiting
Sarasota, Florida, United States, 34232
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
H3 Biomedicine Inc.
Eisai Inc.

Responsible Party: H3 Biomedicine Inc.
ClinicalTrials.gov Identifier: NCT03250676     History of Changes
Other Study ID Numbers: H3B-6545-A001-101
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eisai Inc. ( H3 Biomedicine Inc. ):
HER2
estrogen receptor
H3B-6545
breast cancer
Endocrine Therapy

Additional relevant MeSH terms:
Breast Neoplasms
Adenocarcinoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs