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

  • End date
    Jan 31, 2024
  • participants needed
  • sponsor
    H3 Biomedicine Inc.
Updated on 25 January 2021
measurable disease
breast cancer
growth factor
human epidermal growth factor
epidermal growth factor
estrogen receptor
her2/neu-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 (ER)-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 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].

Condition Breast Cancer, Estrogen Receptor Positive Breast Cancer, Breast Cancer Female, Breast Cancer Diagnosis, ER Positive, Adenocarcinoma of the Breast, Breast Adenocarcinoma, ER+ Breast Cancer, Estrogen Receptor Positive Tumor, breast carcinoma, estrogen receptor-positive breast cancer, cancer, breast, breast tumors, tumor of the breast, breast tumor
Treatment H3B-6545
Clinical Study IdentifierNCT03250676
SponsorH3 Biomedicine Inc.
Last Modified on25 January 2021


Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have any of these conditions: Estrogen Receptor Positive Tumor or Breast Cancer or ER Positive or Breast Cancer Female or Estrogen Receptor Positive Breast Cancer or Breast Adenoca...?
Do you have any of these conditions: cancer, breast or Breast Adenocarcinoma or estrogen receptor-positive breast cancer or breast tumors or Breast Cancer Female or ER+ Breast Cancer or E...?
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 must have received prior cyclin-dependent kinase (CDK4/6) inhibitor therapy
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 must have measurable disease at baseline as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Participants under amendment 6 must have ESR1 Y537S mutation in absence of ESR1 D538G mutation as per the results of a central laboratory

Exclusion Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Phone Email

Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note