A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer

  • STATUS
    Recruiting
  • participants needed
    36
  • sponsor
    H3 Biomedicine Inc.
Updated on 19 February 2024
cancer
estrogen
breast cancer
epidermal growth factor receptor
growth factor
palbociclib
estrogen receptor
epidermal growth factor
stage iv breast cancer
her2/neu-negative breast cancer
HER2
her2- breast cancer
erbb1

Summary

The primary objective of this study is to evaluate the safety and tolerability of H3B-6545 and palbociclib when administered in combination in order to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of this combination in women with advanced or metastatic estrogen receptor-positive (ER+) HER2- breast cancer.

Details
Condition Breast Cancer, Breast Cancer, ERBB2 gene, estrogen receptor
Age 18years - 100years
Treatment Palbociclib (75, 100, 125 milligram [mg]), H3B-6545 (300, 450 mg)
Clinical Study IdentifierNCT04288089
SponsorH3 Biomedicine Inc.
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

ER+ HER2- locally advanced, recurrent, or metastatic breast cancer, as per local laboratory
Prior therapy in the advanced/metastatic setting
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Has adequate bone marrow and organ function

Exclusion Criteria

Uncontrolled significant active infections
Major surgery or other locoregional treatment within 4 weeks before the 1st dose of study drug
Inability to take oral medication or presence of malabsorption
Active cardiac disease or a history of cardiac dysfunction
Evidence of ongoing Alcohol or Drug Abuse
Clear my responses

How to participate?

Step 1 Connect with a study center
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

site

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

Loading...

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

Study AnnotationsStudy Notes

Notes added here are public and can be viewed by anyone. Notes added here are only available to you and those who you share with.

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

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.
Loading...

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