Inflammatory Breast Cancer Clinical Trial
Official title:
A Randomized Phase II Trial Investigating the Addition of Carboplatin to Neoadjuvant Therapy for Triple-negative and HER2-positive Early Breast Cancer
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.
Anthracycline/taxane based combination chemotherapy of at least 18 weeks represents the
standard of care in the neoadjuvant setting. In HER2-positive disease trastuzumab is given
simultaneously to chemotherapy. Recent data from the Neo-Altto and Neosphere trials suggest
that a dual blockage of the HER2 receptor with e.g. trastuzumab and lapatinib reach
significantly higher pCR rates than trastuzumab alone and should therefore represent the
treatment back-bone of new neoadjuvant trials. A preplanned subgroup analysis of the
GeparQuinto study demonstrated that in TNBC the addition of bevacizumab resulted in a
significant increase of pCR rates (HR 1.4).
Having a better cardiac tolerability profile compared to conventional anthracyclines, the
non-pegylated liposomal encapsulated doxorubicin (NPLD) Myocet® might provide the
possibility to combine taxane, anthracycline, platinum salt as well with targeted agents as
double HER2 blockage or bevacizumab.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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