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

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Roche

Status and phase

Completed
Phase 2

Conditions

Breast Cancer

Treatments

Drug: Cyclophosphamide
Drug: Epirubicin
Drug: Docetaxel
Drug: Capecitabine
Drug: 5-Fluorouracil

Study type

Interventional

Funder types

Industry

Identifiers

NCT02846428
ML16986

Details and patient eligibility

About

This study will evaluate the efficacy and safety of treatment with oral capecitabine or intravenous (IV) 5-fluorouracil (5-FU), in combination with epirubicin and cyclophosphamide, prior to surgery in participants with breast cancer. The participants will receive 4 cycles of neoadjuvant Capecitabine + Epirubicin + Cyclophosphamide (CEX) or 5-FU + Epirubicin + Cyclophosphamide (FEC 100) chemotherapy during first treatment period (Period 1, Days 1-85). After 4-6 weeks of the fourth cycle of neoadjuvant chemotherapy (Day 120 +/- 7 days), breast surgery with regional lymph node dissection will be performed, followed within a maximum of 6 weeks by the second treatment period (Period 2, Days 1 to 85) when participants in both study arms will receive 4 cycles of adjuvant docetaxel 100 milligrams per meter square (mg/m^2) by IV infusion on Day 1 of each 21-day cycle. Upon completion of the second treatment period, participants will enter the post-treatment follow-up period which will last for 5 years from the initial date of participant randomization. During this period participants will be evaluated once a year on the anniversary date of randomization.

Enrollment

182 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Females with a unilateral, non-inflammatory, non-multicentric, non-metastatic breast adenocarcinoma, not considered candidates for conservative management, and whose diagnosis had been histologically confirmed as T2-3, N0-1, M0 according to the tumor-nodes-metastasis (TNM) classification
  • Clinically or radiologically measurable lesion (in 2 dimensions)
  • Eastern Cooperative Oncology Group (ECOG) performance Status less than equal to (<=) 1

Exclusion criteria

  • Females presenting with brain metastases or a neurological or psychiatric disorder which could interfere with proper treatment compliance
  • Previous radiotherapy, chemotherapy, or hormonal therapy for breast cancer
  • Previous history of a malignancy in last 5 years other than cutaneous basal cell carcinoma or carcinoma in situ of the uterine cervix
  • Serious concomitant infection
  • Pregnant or lactating females

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

182 participants in 2 patient groups

5-Fluorouracil + Epirubicin + Cyclophosphamide
Active Comparator group
Description:
Neoadjuvant treatment (Period 1): Participants will receive 4 cycles (cycle length = 21 days) of 5-FU + epirubicin + cyclophosphamide. Surgery will be performed 5 (+/- 1) weeks after the last cycle. Adjuvant treatment (Period 2): Participants will receive 4 cycles (cycle length = 21 days) of docetaxel.
Treatment:
Drug: Cyclophosphamide
Drug: 5-Fluorouracil
Drug: Epirubicin
Drug: Docetaxel
Capecitabine + Epirubicin + Cyclophosphamide
Experimental group
Description:
Neoadjuvant treatment (Period 1): Participants will receive 4 cycles (cycle length = 21 days) of capecitabine + epirubicin + cyclophosphamide. Surgery will be performed 5 (+/- 1) weeks after the last cycle. Adjuvant treatment (Period 2): Participants will receive 4 cycles (cycle length = 21 days) of docetaxel.
Treatment:
Drug: Cyclophosphamide
Drug: Capecitabine
Drug: Epirubicin
Drug: Docetaxel

Trial contacts and locations

21

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Data sourced from clinicaltrials.gov

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