CA209-7FL- Nivo vs Placebo with Chemo & Endocrine Therapy in Breast CA

• Research type

  Research Study

• Full 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

• IRAS ID

  271049

• Contact name

  Head of Global Clinical Trial Submission Unit

• Contact email

  gct-su@bms.com

• Sponsor organisation

  Bristol-Myers Squibb International Corporation

• Eudract number

  2019-002469-37

• Clinicaltrials.gov Identifier

  NCT04109066

• Clinicaltrials.gov Identifier

  41548, NIHR Reference Number

• Duration of Study in the UK

  12 years, 3 months, 28 days

• Research summary

  This is a multicentre, phase 3 study in patients with newly diagnosed untreated breast cancer.

  The study will compare treatment with either nivolumab given at the same time as chemotherapy or chemotherapy given alone before breast surgery, followed by nivolumab given at the same time as endocrine treatment or endocrine treatment given alone.
  
  The objective is to see whether one treatment regimen will increase the length of time before either the cancer gets worse or the patient dies compared to the other; and whether one treatment regimen will reduce the appearance of the disease in breast and lymph node tissue.

  1200 patients will take part with approximately 35 patients in the UK
  Patients will randomly be assigned to one of two treatment arms:

  Arm A:
  • Nivolumab 360mg + paclitaxel for 4 cycles, followed by
  • Nivolumab 360mg every 3 weeks or Nivolumab 240mg every 2 weeks + anthracycline and cyclophosphamide for 4 cycles
  
  
  Arm B:
  • Nivolumab Placebo + paclitaxel for 4 cycles, followed by
  • Nivolumab Placebo every 3 weeks or every 2 weeks + anthracycline and cyclophosphamide for 4 cycles
  
  Patients in both arms will undergo breast surgery after pre-surgery treatment. After surgery, Arm A patients will receive Nivolumab 480mg + endocrine treatment and Arm B patients will receive Nivolumab placebo + endocrine treatment, for 7 cycles.

  Treatment will be discontinued if the patient withdraws consent, if their cancer gets worse or if it’s no longer safe for the patient to continue.

  Patients will undergo the following procedures vital signs, physical exams, image assessments, blood sampling and surgery. They will complete questionnaires on their wellbeing. A biopsy will be collected at screening if existing tissue is not available, and before surgery. Patients will have the first 2 follow-up visits in person. The remainder will be completed in person or by telephone.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  20/SC/0036

• Date of REC Opinion

  26 Mar 2020

• REC opinion

  Further Information Favourable Opinion