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Fluorouracil; 500 mg/m2; day 1 Epirubicine; 90 mg/m2; day 1 Cyclophosphamide; 500 mg/m2; day 1 Trastuzumab; 6 mg/kg (loading dose 8 mg/kg) Pertuzumab; 420 mg (loading dose 840 mg); day 1 Cycle is repeated every 21 days

Paclitaxel; 80 mg/m2; day 1,8 Trastuzumab; 6 mg/kg (loading dose 8 mg/kg); day 1 Carboplatin; AUC=6; day 1 Pertuzumab; 420 mg (loading dose 840 mg); day 1 Cycle repeated every 21 days

PTC+Pertuzumab

FEC-T+Pertuzumab

Gabe S Sonke, MD

This study compares two schedules of upfront chemotherapy in HER positive breast cancer.

Upfront trastuzumab treatment is beneficial to patients with HER2 positive breast cancer. The potential synergistic cardiotoxicity of trastuzumab and anthracyclines has led to the development of non-anthracycline containing regimens, which have shown high pathologic complete response rates. Anthracyclines remain very active in HER2 positive breast cancer, however, and increasing evidence now supports safe combination of trastuzumab and epirubicin. Therefore, the addition of epirubicin to a non-anthracycline containing regimen may further improve outcome for patients with HER2 positive breast cancer.

Several reports confirmed benefit of dual HER2 blockade by adding pertuzumab to a trastuzumab containing neoadjuvant regimen. The results of the combined treatment in the Neosphere study, however, are similar to what we found in a phase II trial using a weekly paclitaxel, trastuzumab, carboplatin combination with pCR rates of approximately 44%. Adding pertuzumab to this regimen is likely to also increase the high pCR rate and to add substantial benefit to patients.

Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer, TRAIN-2

Optimizing Neoadjuvant Systemic Treatment for HER2 Positive Breast Cancer - the TRAIN-2 Study

To compare the efficacy of six cycles neoadjuvant PTC plus pertuzumab preceded by either three cycles of FEC-T plus pertuzumab or three cycles of PTC plus pertuzumab in HER2 positive breast cancer

to describe the safety of the various regimens toxicity is compared between the two arms

To identify prognostic and predictive biomarkers for pCR after neoadjuvant treatment

Roche Pharma AG

Borstkanker Onderzoek Groep

The Netherlands Cancer Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer, TRAIN-2	NCT01996267	Breast Cancer HER2 Positive	PTC+Pertuzumab FEC-T+Pertuzuma...	18 Years -	The Netherlands Cancer Institute
Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer, TRAIN-2	NCT01996267	Breast Cancer HER2 Positive	PTC+Pertuzumab FEC-T+Pertuzuma...	18 Years -	The Netherlands Cancer Institute
Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer, TRAIN-2	NCT01996267	Breast Cancer HER2 Positive	PTC+Pertuzumab FEC-T+Pertuzuma...	18 Years -	The Netherlands Cancer Institute

Spots Global Cancer Trial Database for ptc+pertuzumab