To Evaluate the Efficacy and Safety of Capecitabine Prior to Surgery in Women With Breast Cancer
NCT ID: NCT02846428
Last Updated: 2016-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
182 participants
INTERVENTIONAL
2004-03-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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5-Fluorouracil + Epirubicin + 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.
5-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.
Cyclophosphamide
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
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
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.
Capecitabine + Epirubicin + 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
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
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
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
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.
Interventions
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5-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.
Capecitabine
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
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
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinically or radiologically measurable lesion (in 2 dimensions)
* Eastern Cooperative Oncology Group (ECOG) performance Status less than equal to (\<=) 1
Exclusion Criteria
* 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
18 Years
70 Years
FEMALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_CHAIR
Hoffmann-La Roche
Locations
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Bayonne, , France
Béziers, , France
Bourg-en-Bresse, , France
Colmar, , France
Dijon, , France
Hyères, , France
La Tronche, , France
Le Mans, , France
Limoges, , France
Lyon, , France
Marseille, , France
Montbéliard, , France
Montfermeil, , France
Nice, , France
Nîmes, , France
Paris, , France
Pierre-Bénite, , France
Saint-Herblain, , France
Strasbourg, , France
Toulouse, , France
Vannes, , France
Countries
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Other Identifiers
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ML16986
Identifier Type: -
Identifier Source: org_study_id
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