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Brief Title: Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer, TRAIN-2
Official Title: Optimizing Neoadjuvant Systemic Treatment for HER2 Positive Breast Cancer - the TRAIN-2 Study
Study ID: NCT01996267
Brief Summary: This study compares two schedules of upfront chemotherapy in HER positive breast cancer.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
MCA, Alkmaar, , Netherlands
ZGT, Almelo, , Netherlands
Antoni van Leeuwenhoek, Amsterdam, , Netherlands
AZVU, Amsterdam, , Netherlands
OLVG, Amsterdam, , Netherlands
Rode Kruis Ziekenhuis, Beverwijk, , Netherlands
Amphia ziekenhuis, Breda, , Netherlands
Reinier de Graaf Groep, Delft, , Netherlands
Jeroen Bosch Hospital, Den Bosch, , Netherlands
Haga, Den Haag, , Netherlands
Bronovo Ziekenhuis, den Haag, , Netherlands
Deventer ziekenhuis, Deventer, , Netherlands
Ziekenhuis Gelderse Vallei, Ede, , Netherlands
Catharina Ziekenhuis, Eindhoven, , Netherlands
Maxima Medisch Centrum, Eindhoven, , Netherlands
St Anna Geldrop, Geldrop, , Netherlands
Orbis Medisch Centrum, Geleen, , Netherlands
Groene Hart, Gouda, , Netherlands
Kennemer Gasthuis, Haarlem, , Netherlands
Atrium Medisch Centrum Parkstad, Heerlen, , Netherlands
Spaarne ziekenhuis, Hoofddorp, , Netherlands
Westfries Gasthuis, Hoorn, , Netherlands
MCL, Leeuwarden, , Netherlands
LUMC, Leiden, , Netherlands
Diaconessenhuis Meppel, Meppel, , Netherlands
Canisius-Wilhelmina Hospital, Nijmegen, , Netherlands
Waterlandziekenhuis, Purmerend, , Netherlands
Vlietland Ziekenhuis, Schiedam, , Netherlands
St. Elisabeth, Tilburg, , Netherlands
Diaconessenhuis Utrecht, Utrecht, , Netherlands
VieCuri Medisch Centrum voor Noord-Limburg, Venlo, , Netherlands
Zaans Medisch Centrum, Zaandam, , Netherlands
Isala Klinieken, Zwolle, , Netherlands
Name: Gabe S Sonke, MD
Affiliation: Antoni van Leeuwenhoek, Amsterdam
Role: PRINCIPAL_INVESTIGATOR