CheckMate 7FL
03 Dec 2020
Trial Summary
A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) early stage breast cancer.
Acronym:
CheckMate 7FL
ACTRN/NCT /ethics:
NCT04109066
Scientific title:
A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer
Sponsor / Cooperative group:
Bristol-Myers Squibb
Trial & Patient Characteristics
| Cancer Type | Breast |
|---|---|
| Trial Type | Treatment |
| Phase | Phase III |
| Age Range | 18 years and older |
| Sex | All |
| Tumour Stream | - |
| Cancer Stage | Locally Recurrent or Locally Advanced |
| Anticipated Start Date | 2019-11-20 |
| Anticipated End Date | 2032-06-30 |
Participating Hospitals
| Hospital | Calvary Central Districts Hospital |
|---|---|
| Clinical Trial Coordinator | Julie Rowe |
| julie.rowe@calvarycare.org.au | |
| Phone | 08 8239 9536 |
| Principal Investigator | Dr Rohit Joshi |
| Recruitment Status | Recruiting |