A Randomized Phase II Trial Investigating the Addition of Carboplatin to Neoadjuvant Therapy for Triple-negative and HER2-positive Early Breast Cancer (GeparSixto)

NCT01426880 Phase 2/Phase 3 COMPLETED

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.

Details

Lead sponsor	GBG Forschungs GmbH
Phase	Phase 2/Phase 3
Status	COMPLETED
Enrolment	595
Start date	2011-08
Completion	2013-08

Conditions

• Tubular Breast Cancer Stage II
• Mucinous Breast Cancer Stage II
• Breast Cancer Female NOS
• Invasive Ductal Breast Cancer
• Tubular Breast Cancer Stage III
• HER-2 Positive Breast Cancer
• Inflammatory Breast Cancer Stage IV
• Inflammatory Breast Cancer

Interventions

• Carboplatin
• background treatment

Primary outcomes

• Pathological complete response of breast and lymph nodes (ypT0 ypN0; primary endpoint) — 24 weeks (time window -3 weeks)
  Pathological response will be assessed considering all removed breast and lymphatic tissues from all surgeries. Surgery takes place shortly after the 18 weeks (six 3-week cycles) chemotherapy treatment. No microscopic evidence of residual viable tumor cells in all resected specimens of the breast and axilla meets the primary endpoint.

Countries

Germany