Randomized CT to Evaluate Efficacy of Neoadjuvant Chemotherapy Customized by Levels of BRCA1-HER2 Negative Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

October 10, 2016

Study Completion Date

October 10, 2016

Conditions
Breast Cancer
Interventions
DRUG

Epirubicin + Ciclofosfamide + Fluorouracil + Paclitaxel

Epirubicin 90 mg/m2 + Ciclofosfamide 600 mg/m2 + 5-Fluorouracil 600 mg/m2 intravenous infusion on day 1 every three weeks, for four cycles; followed by Paclitaxel 100 mg/m2 weekly for eight weeks.

DRUG

Epirubicin + Cisplatin + Fluorouracil

Epirubicin 60 mg/m2 + Cisplatin 60 mg/m2 intravenous infusion on day 1 every three weeks and 5-Fluorouracil 200 mg/m2/day for eight cycles.

DRUG

Docetaxel + Ciclofosfamide

Docetaxel 75 mg/m2 + Ciclofosfamide 600 mg/m2, intravenous infusion on day 1 every three weeks, for eight cycles.

Trial Locations (7)

11009

Hospital Universitario Puerta del Mar, Cadiz

14004

Hospital Universitario Reina Sofía, Córdoba

21005

Hospital Universitario Juan Ramón Jimenez, Huelva

23007

Complejo Hospitalario de Jaén, Jaén

41007

Hospital Universitario Virgen Macarena, Seville

41013

Hospital Universitario Virgen del Rocío, Seville

41014

Hospital Universitario Nuestra Señora de Valme, Seville

All Listed Sponsors
lead

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

NCT02365805 - Randomized CT to Evaluate Efficacy of Neoadjuvant Chemotherapy Customized by Levels of BRCA1-HER2 Negative Breast Cancer | Biotech Hunter | Biotech Hunter