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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 TypeBreast
Trial TypeTreatment
PhasePhase III
Age Range18 years and older
SexBoth
Tumour Stream -
Cancer StageLocally Recurrent or Locally Advanced
Anticipated Start Date2019-10-25
Anticipated End Date2032-06-30

Participating Hospitals

HospitalCalvary Central Districts Hospital
Clinical Trial CoordinatorJulie Rowe
Emailjulie.rowe@calvarycare.org.au
Phone08 8239 9536
Principal InvestigatorDr Rohit Joshi
Recruitment StatusRecruiting