To Evaluate the Efficacy and Safety of Capecitabine Prior to Surgery in Women With Breast Cancer
An Open-Label, Multicenter, Randomized, Phase II Study to Evaluate the Efficacy and Safety of Two Combination Dose Regimens: Capecitabine + Epirubicin + Cyclophosphamide (CEX) Versus 5-FU + Epirubicin + Cyclophosphamide (FEC 100) as Neoadjuvant Therapy in Females Presenting With Operable Breast Cancer
1 other identifier
interventional
182
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Mar 2004
Longer than P75 for phase_2 breast-cancer
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 25, 2016
CompletedFirst Posted
Study publicly available on registry
July 27, 2016
CompletedJuly 27, 2016
July 1, 2016
7.8 years
July 25, 2016
July 25, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (12)
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
- +7 more secondary outcomes
Study Arms (2)
5-Fluorouracil + Epirubicin + Cyclophosphamide
ACTIVE COMPARATORNeoadjuvant 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
EXPERIMENTALNeoadjuvant 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.
Interventions
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Unknown Facility
Bayonne, 64100, France
Unknown Facility
Béziers, 34500, France
Unknown Facility
Bourg-en-Bresse, 01012, France
Unknown Facility
Colmar, 68024, France
Unknown Facility
Dijon, 21079, France
Unknown Facility
Hyères, 83400, France
Unknown Facility
La Tronche, 38700, France
Unknown Facility
Le Mans, 72037, France
Unknown Facility
Limoges, 87042, France
Unknown Facility
Lyon, 69437, France
Unknown Facility
Marseille, 13385, France
Unknown Facility
Montbéliard, 25209, France
Unknown Facility
Montfermeil, 93370, France
Unknown Facility
Nice, 06189, France
Unknown Facility
Nîmes, 30029, France
Unknown Facility
Paris, 75181, France
Unknown Facility
Pierre-Bénite, 69310, France
Unknown Facility
Saint-Herblain, 44805, France
Unknown Facility
Strasbourg, 67010, France
Unknown Facility
Toulouse, 31059, France
Unknown Facility
Vannes, 56001, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2016
First Posted
July 27, 2016
Study Start
March 1, 2004
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
July 27, 2016
Record last verified: 2016-07