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
Receptors, Estrogen, Genes, Erbb-2, Breast Neoplasms
About this trial
This is an interventional treatment trial for Receptors, Estrogen focused on measuring H3B-6545, Palbociclib, Metastatic Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Eligibility Criteria
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
Sites / Locations
- Florida Cancer Specialists South - SCRI - PPDS
- Massachusetts General Hospital
- Saint Luke's Cancer Institute
- Comprehensive Cancer Centers of Nevada
- Tennessee Oncology, PLLC - SCRI - PPDS
- Royal Marsden NHS Foundation Trust
- Sarah Cannon Research Institute UK - SCRI
- Royal Marsden NHS Foundation Trust
Arms of the Study
Arm 1
Experimental
Palbociclib + H3B-6545 (Dose Escalation and Dose Expansion)
Participants will receive Palbociclib 75, 100, 125 milligram (mg) capsules or tablets, orally, once daily from Days 1 to 21 followed by 7 days off treatment in 28-day cycles along with H3B-6545 150, 300, 450 mg capsules or tablets, orally, once daily from Days 1 to 28 in 28-day cycles in dose escalation part. Based on MTD or RP2D determined for H3B-6545 in combination with palbociclib in dose escalation part, participants will continue to receive study treatment in dose expansion part until PD, development of unacceptable toxicity, or withdrawal of consent (up to 24 months).