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Spots Global Cancer Trial Database for Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer, TRAIN-2

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Gabe S Sonke, MD

Affiliation: Antoni van Leeuwenhoek, Amsterdam

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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