To Evaluate the Efficacy and Safety of Capecitabine Prior to Surgery in Women With Breast Cancer
Phase 2
Completed
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT02846428
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 182
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 5-Fluorouracil + Epirubicin + Cyclophosphamide Docetaxel 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. 5-Fluorouracil + Epirubicin + Cyclophosphamide Epirubicin 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. 5-Fluorouracil + Epirubicin + Cyclophosphamide 5-Fluorouracil 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. 5-Fluorouracil + Epirubicin + Cyclophosphamide Cyclophosphamide 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. Capecitabine + Epirubicin + Cyclophosphamide Capecitabine 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. Capecitabine + Epirubicin + Cyclophosphamide Cyclophosphamide 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. Capecitabine + Epirubicin + Cyclophosphamide Docetaxel 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. Capecitabine + Epirubicin + Cyclophosphamide Epirubicin 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Percentage of participants with pathological complete tumor response Assessed by Investigator according to the Sataloff classification Day 120 +/- 7 days 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 who died Baseline up to 29 +/- 1 weeks 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