ALEXANDRA / IMpassion030 (BIG 16-05)

A phase III, multicenter, randomised, 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 (TNBC).

ALEXANDRA / IMpassion030 aims to assess whether adding the anti-PD-L1 monoclonal antibody atezolizumab to chemotherapy after surgery is better at preventing cancer recurrence, compared to chemotherapy alone in patients with triple-negative breast cancer.

Triple-negative breast cancer (TNBC) is a type of breast cancer that tests negative for three markers: estrogen receptors (ER), progesterone receptors (PR) and human epidermal receptor-2 (HER2), which means that this form of the disease does not respond to hormonal therapy or anti-HER2 treatments.

It is considered to be more aggressive than other types of breast cancer and is associated with a high risk of distant relapse. Because TNBC does not currently have specific targeted agents approved for use in the early setting it is treated primarily with chemotherapy [1].

The anti-PD-L1 atezolizumab is a form of immunotherapy, i.e. it helps patients’ immune systems to recognize and fight cancer cells. Researchers aim to see if combining this immunotherapy with standard chemotherapy after surgery improves patient outcome and helps prevent cancer from coming back.

Patients are randomly assigned to one of the following treatment groups:

  • Anti-PD-L1 monoclonal antibody plus chemotherapy
  • Chemotherapy alone

Patients receiving atezolizumab will be treated for one year. The study will compare results between the two treatment groups, looking at the invasive disease-free survival (iDFS), iDFS by PD-L1 and lymph node status, overall survival, safety, patient functioning and health related quality of life [1]

Tumour tissue and blood samples will be collected for biomarker research.

ALEXANDRA / IMpassion030 aims to recruit globally 2,300 women and men who are 18 years and older with non-metastatic operable stage II-III TNBC.

Coordinating partners: Breast International Group (BIG), Alliance Foundation Trials (AFT), Institut Jules Bordet/Clinical Trials Support Unit (IJB/CTSU) and Frontier Science and Technology Research Foundation Inc (FSTRF).

Recruitment opened in August 2018 and study completion is expected 7 years after the first patient recruitment.

International clinical trial, involving 21 BIG member groups, and 430 sites in 30 countries: Argentina, Australia, Austria, Belgium, Brazil, China, Czech Republic, Denmark, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Mexico, Peru, Poland, Romania, Russia, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom, United States of America.

Hoffmann-La Roche is the sponsor and funder of the study.

The study was designed by BIG, its academic partners and Roche. This trial is conducted following BIG’s Principles of Research Conduct.

ClinicalTrials.gov Identifier: NCT03498716