Phase 1b study of H3B-6545 with palbociclib for breast cancer
Research type
Research Study
Full title
An open-label multicenter Phase 1b study of H3B-6545 in combination with palbociclib in women with advanced or metastatic estrogen receptor-positive, HER2-negative breast cancer
IRAS ID
278092
Contact name
Stephen Johnston
Contact email
Sponsor organisation
Eisai Inc.
Eudract number
2019-004622-17
Clinicaltrials.gov Identifier
133282, IND Number
Duration of Study in the UK
1 years, 10 months, 0 days
Research summary
Breast cancer is the most common cancer in the UK, accounting for 15% of all new cancer cases. Roughly 80% of breast cancers express the oestrogen receptor (ER) and most of these cancers depend on ER for tumour growth and progression. Current treatment for most women with advanced ER positive (HER2 negative) breast cancer is a combination of hormone therapy and CDK4/6 inhibitor such as palbociclib. However, nearly all patients will relapse and treatment for recurrent disease is suboptimal.
H3B-6545 is a novel treatment which inactivates ER and has shown promising activity as a single treatment. Combination with palbociclib further improves efficacy in multiple laboratory models of breast cancer. H3B-6545 is currently being tested as a single treatment in patients with ER+ HER2- breast cancer. It has shown promising anti-cancer activity and is generally well tolerated.
The purpose of this study is to evaluate the safety and tolerability of H3B-6545 and palbociclib when administered together and determine suitable dose levels. Groups of patients will be given escalating doses of H3B-6545 and palbociclib until the highest tolerated dose is reached. This dose will then be given to an expanded group of patients.
Patients will commence H3B-6545 treatment on Day 9 of Cycle 1 and take it orally every day of each 28-day cycle. Patients will take palbociclib orally on Days 1-21 of each 28-day cycle. Treatment will continue until disease progression, unacceptable side effects or withdrawal of consent.
After screening, patients will attend for 5 visits during Cycle 1, 3 visits during Cycle 2 and 1 visit during subsequent cycles. Study procedures include physical examination, ECG, blood and urine tests and imaging scans.
This study is sponsored by Eisai Inc. Approximately 36 patients will participate in the UK and USA with 16 patients from 2 hospitals in the UK.
REC name
London - Chelsea Research Ethics Committee
REC reference
20/LO/0739
Date of REC Opinion
21 Sep 2020
REC opinion
Further Information Favourable Opinion