To Evaluate the Efficacy and Safety of Capecitabine Prior to Surgery in Women With Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

182

Participants

Timeline

Start Date

March 31, 2004

Primary Completion Date

December 31, 2011

Study Completion Date

December 31, 2011

Conditions
Breast Cancer
Interventions
DRUG

5-Fluorouracil

5-FU will be administered at 500 mg/m\^2 by short IV infusion on Day 1 of each 21-day cycle during neoadjuvant treatment period for 4 cycles.

DRUG

Capecitabine

Capecitabine will be administered at 900 mg/m\^2 orally twice daily on Days 1-14 of each 21-day cycle for 4 cycles during neoadjuvant treatment period.

DRUG

Cyclophosphamide

Cyclophosphamide will be administered at 500 mg/m\^2 by short IV infusion on Day 1 of each 21-day cycle for 4 cycles during neoadjuvant treatment period.

DRUG

Docetaxel

Docetaxel will be administered at 100 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles during adjuvant treatment period.

DRUG

Epirubicin

Epirubicin will be administered at 100 mg/m\^2 by short IV infusion on Day 1 of each 21-day cycle for 4 cycles during neoadjuvant treatment period.

Trial Locations (21)

13385

Marseille

21079

Dijon

25209

Montbéliard

30029

Nîmes

31059

Toulouse

34500

Béziers

38700

La Tronche

44805

Saint-Herblain

56001

Vannes

64100

Bayonne

67010

Strasbourg

68024

Colmar

69310

Pierre-Bénite

69437

Lyon

72037

Le Mans

75181

Paris

83400

Hyères

87042

Limoges

93370

Montfermeil

01012

Bourg-en-Bresse

06189

Nice

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02846428 - To Evaluate the Efficacy and Safety of Capecitabine Prior to Surgery in Women With Breast Cancer | Biotech Hunter | Biotech Hunter