Clinical trial NCT02846428: To Evaluate the Efficacy and Safety of Capecitabine Prior to Surgery in Women With Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-07-27
Enrollment: 182
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of participants with pathological complete tumor response Assessed by Expert Blinded Independent Review according to the Sataloff classification\n
timeFrame: Day 120 +/- 7 days
Secondary outcomes:
measure: Percentage of participants with pathological complete tumor response Assessed by Investigator according to the Sataloff classification
timeFrame: Day 120 +/- 7 days
measure: Percentage of participants with breast conserving surgery
timeFrame: Day 120 +/- 7 days
measure: Percentage of participants with objective clinical response, assessed by World Health Organization (WHO) criteria
timeFrame: Week 15
measure: Percentage of participants with clinical response, assessed by WHO criteria
timeFrame: Week 15
measure: Percentage of participants with disease progression, assessed by WHO criteria
timeFrame: Baseline up to 29 +/- 1 weeks
measure: Percentage of participants with abnormalities in bilateral mammography
timeFrame: Day 85
measure: Percentage of participants who died
timeFrame: Baseline up to 29 +/- 1 weeks
measure: Percentage of participants with abnormal left ventricular ejection fraction (LVEF)
timeFrame: Days 1-85
measure: Percentage of participants with abnormal liver ultrasound
timeFrame: Days 1-85
measure: Percentage of participants with abnormal Chest X-Ray
timeFrame: Days 1-85
measure: Overall survival
timeFrame: Baseline up to 5 years
measure: Disease free survival, according to WHO criteria
timeFrame: Baseline up to 5 years
Other outcomes:
Locations:
city: Bayonne
country: France
city: Beziers
country: France
city: Bourg En Bresse
country: France
city: Colmar
country: France
city: Dijon
country: France
city: Hyeres
country: France
city: La Tronche
country: France
city: Le Mans
country: France
city: Limoges
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Montbeliard
country: France
city: Montfermeil
country: France
city: Nice
country: France
city: Nimes
country: France
city: Paris
country: France
city: Pierre Benite
country: France
city: Saint Herblain
country: France
city: Strasbourg
country: France
city: Toulouse
country: France
city: Vannes
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: