Breast Cancer
Conditions
Brief summary
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.
Interventions
DRUG5-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.
DRUGCapecitabine
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.
DRUGCyclophosphamide
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.
DRUGDocetaxel
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.
DRUGEpirubicin
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.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with pathological complete tumor response Assessed by Expert Blinded Independent Review according to the Sataloff classification\n | Day 120 +/- 7 days |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants with breast conserving surgery | Day 120 +/- 7 days |
| Percentage of participants with objective clinical response, assessed by World Health Organization (WHO) criteria | Week 15 |
| Percentage of participants with clinical response, assessed by WHO criteria | Week 15 |
| Percentage of participants with disease progression, assessed by WHO criteria | Baseline up to 29 +/- 1 weeks |
| Percentage of participants with abnormalities in bilateral mammography | Day 85 |
| Percentage of participants with pathological complete tumor response Assessed by Investigator according to the Sataloff classification | Day 120 +/- 7 days |
| Percentage of participants with abnormal left ventricular ejection fraction (LVEF) | Days 1-85 |
| Percentage of participants with abnormal liver ultrasound | Days 1-85 |
| Percentage of participants with abnormal Chest X-Ray | Days 1-85 |
| Overall survival | Baseline up to 5 years |
| Disease free survival, according to WHO criteria | Baseline up to 5 years |
| Percentage of participants who died | Baseline up to 29 +/- 1 weeks |
Countries
France
Outcome results
None listed