H3B-6545 + Palbociclib for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is the combination of H3B-6545 and Palbociclib safe for humans?
Palbociclib (also known as Ibrance) has been shown to have a manageable safety profile in treating advanced breast cancer, with neutropenia (a low level of white blood cells) being the most common side effect. It is generally well-tolerated when combined with other cancer treatments, maintaining patients' quality of life.12345
What makes the drug combination H3B-6545 and Palbociclib unique for breast cancer treatment?
The combination of H3B-6545 and Palbociclib is unique because Palbociclib is a selective inhibitor of cyclin-dependent kinases (CDK) 4 and 6, which are important for cell cycle progression, and it is used in hormone receptor-positive, HER2-negative advanced breast cancer. This combination may enhance the effectiveness of treatment by targeting specific pathways involved in cancer cell growth.26789
What data supports the effectiveness of the drug combination H3B-6545 and Palbociclib for breast cancer?
Palbociclib, a part of the treatment, has been shown to be effective in treating advanced breast cancer when combined with other drugs, significantly prolonging the time patients live without the cancer getting worse. In real-world studies, it has been well tolerated and effective, with high progression-free and survival rates.1381011
Are You a Good Fit for This Trial?
This trial is for women with advanced or metastatic estrogen receptor-positive, HER2-negative breast cancer. Participants should have had prior therapy in the advanced/metastatic setting and be in good physical condition (ECOG status of 0 or 1). They must also have proper bone marrow and organ function. Women with uncontrolled infections, recent major surgery, issues taking oral medication, substance abuse problems, or active heart disease are not eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive Palbociclib and H3B-6545 in escalating doses to determine the maximum tolerated dose (MTD)
Dose Expansion
Participants continue to receive study treatment at the recommended Phase 2 dose (RP2D) until disease progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- H3B-6545
- Palbociclib
Find a Clinic Near You
Who Is Running the Clinical Trial?
H3 Biomedicine Inc.
Lead Sponsor
Eisai Inc.
Lead Sponsor
Lynn Kramer
Eisai Inc.
Chief Medical Officer since 2019
MD
Tatsuyuki Yasuno
Eisai Inc.
Chief Executive Officer since 2023
MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University