IMpassion 030

• Research type

  Research Study

• Full title

  A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY COMPARING ATEZOLIZUMAB (ANTIPD-L1 ANTIBODY) IN COMBINATION WITH ADJUVANT ANTHRACYCLINE/TAXANE-BASED CHEMOTHERAPY VERSUS CHEMOTHERAPY ALONE IN PATIENTS WITH OPERABLE TRIPLE NEGATIVE BREAST CANCER

• IRAS ID

  232910

• Contact name

  Daljit Gahir

• Contact email

  daljit.gahir@uhnm.nhs.uk

• Sponsor organisation

  F. Hoffman-La Roche Ltd.

• Eudract number

  2016-003695-47

• Clinicaltrials.gov Identifier

  123277, IND Number

• Duration of Study in the UK

  6 years, 9 months, 15 days

• Research summary

  This is a phase 3, multicentre, randomised, open-label, safety, efficacy and pharmacokinetic study comparing atezolizumab in combination with adjuvant chemotherapy versus chemotherapy alone in patients with operable Stage II-III breast cancer. Eligible participants will have confirmed ‘triple-negative’ breast cancer (TNBC).

  Breast cancer is the second most common invasive cancer and the most common cause of cancer-related mortality in women. Patients with TNBC are more likely to have rapid disease progression and lower overall survival than other types of breast cancer. Chemotherapy has proven beneficial for early-stage TNBC patients however 30-40% of patients still experience fatal disease progression. There is a need to improve long-term treatment outcomes for patients with early-stage TNBC.

  Atezolizumab is a type of medication called a PD-L1 antagonist and is a form of cancer immune therapy. This means it tries to help the body’s immune system to recognise and fight off cancer cells. Atezolizumab has demonstrated anti-tumour activity in patients with different tumour types and is currently being investigated as a potential treatment across a wide range of cancers.

  Chemotherapy investigational medications that will be used in this study are: paclitaxel, doxorubicin, epirubicin and cyclophosphamide.

  It is expected that approximately 2300 male and female participants aged 18 years or older will be enrolled, in approximately 370-450 sites globally. Once enrolled, participants will be randomised into one of two arms, Arm A (where the participant will receive atezolizumab alongside Chemotherapy) or Arm B (where the participant will receive Chemotherapy only). The participants will attend roughly 29 study visits in the first year where they will be receiving the medication described above. After this, there will be a follow-up period of up of 6 years. The total duration of the study is therefore expected to be approximately 7 years after the first participant is randomised.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  18/LO/1843

• Date of REC Opinion

  23 Jan 2019

• REC opinion

  Further Information Favourable Opinion