Addition of Carboplatin to Neoadjuvant Therapy for Triple-negative and HER2-positive Early Breast Cancer
Status:
Completed
Trial end date:
2013-08-01
Target enrollment:
Participant gender:
Summary
Study participants with primary breast cancer will receive a standard chemotherapy with an
anthracycline and a taxane as well as trastuzumab in case of HER2-positive tumors at doses
and duration in concordance to current treatment guidelines. Patients will be receive and
benefit in addition currently not in the neoadjuvant setting registered medication as
lapatinib or bevacizumab of which significant increases of cure (pCR) rates have been
reported in previous phase III studies. Patients randomized to carboplatin will receive in
addition to the described backbone therapies a potentially active agent which suggested
synergy of efficacy with chemotherapies as well as targeted agents. Patients might have the
risk of an increase in toxicities due to the added agents and will have additional burden due
to investigations required for study participation. However, due to the severity of the
underlying disease and the high risk of relapse and death due to the stage of disease, this
increase in toxicity and burden appears less relevant compared to the potential higher
efficacy and finally cure rate by the incorporated treatments.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
German Breast Group
Collaborators:
GlaxoSmithKline Roche Pharma AG TEVA Teva Pharmaceuticals USA