OncRef

Clinical Trial: NCT00129935

EC Followed Docetaxel Versus ET Followed Capecitabine as Adjuvant Chemotherapy for Node Positive Operable Breast Cancer

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Spanish Breast Cancer Research Group
Information Provided By:Spanish Breast Cancer Research Group
Last Update Posted:2023-03-31

Study Overview

Brief Summary

This is a prospective, randomised phase III trial, to compare the efficacy and safety profiles of two types of adjuvant chemotherapy regimens for human epidermal growth factor receptor 2 (HER2) negative, node positive breast cancer patients.

Control Arm: This includes 4 cycles of EC 90/600 mg/m2 day 1 every 3 weeks, followed by 4 cycles of T 100 mg/m2 day 1 every 3 weeks.

Experimental Arm: This includes 4 cycles of ET 90/75 mg/m2, day 1 every 3 weeks, followed by 4 cycles of capecitabine 1250 mg/m2, twice a day, via oral intake, for 14 days, and then a one-week rest period.

Premenopausal women with hormone receptor positive tumours must receive 5 years of tamoxifen after the end of chemotherapy.

Postmenopausal women with hormone receptor positive tumours can receive tamoxifen or aromatase inhibitors (or both) after the end of chemotherapy.

Patients may receive radiotherapy when clinically indicated.

Official Title

Phase III Trial to Compare Epirubicin and Cyclophosphamide (EC) Followed by Docetaxel (T) to Epirubicin and Docetaxel (ET) Followed by Capecitabine (X) as Adjuvant Treatment, Node Positive Breast Cancer Patients

Conditions

Breast Cancer

Intervention / Treatment

  • Drug: Docetaxel
  • Drug: Capecitabine
  • Drug: Epirubicin
  • Drug: Cyclophosphamide

Other Study ID Numbers

  • GEICAM 2003-10

Start Date (Actual)

2004-02

Primary Completion Date (Actual)

2013-06

Study Completion Date (Actual)

2019-04-04

Enrollment (Actual)

1384

Study Type

Interventional

Phase

Phase 3