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

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)

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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