To Evaluate the Efficacy and Safety of Capecitabine Prior to Surgery in Women With Breast Cancer

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02846428
• Other study ID #: ML16986
• Status: Completed
• Phase: Phase 2
• First received: July 25, 2016
• Last updated: July 25, 2016
• Start date: March 2004
• Est. completion date: December 2011

Study information

• Verified date: July 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Medical Agency (ANSM)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with pathological complete tumor response Assessed by Expert Blinded Independent Review according to the Sataloff classification\n		Day 120 +/- 7 days	No
Secondary	Percentage of participants with pathological complete tumor response Assessed by Investigator according to the Sataloff classification		Day 120 +/- 7 days	No
Secondary	Percentage of participants with breast conserving surgery		Day 120 +/- 7 days	No
Secondary	Percentage of participants with objective clinical response, assessed by World Health Organization (WHO) criteria		Week 15	No
Secondary	Percentage of participants with clinical response, assessed by WHO criteria		Week 15	No
Secondary	Percentage of participants with disease progression, assessed by WHO criteria		Baseline up to 29 +/- 1 weeks	No
Secondary	Percentage of participants with abnormalities in bilateral mammography		Day 85	No
Secondary	Percentage of participants who died		Baseline up to 29 +/- 1 weeks	No
Secondary	Percentage of participants with abnormal left ventricular ejection fraction (LVEF)		Days 1-85	No
Secondary	Percentage of participants with abnormal liver ultrasound		Days 1-85	No
Secondary	Percentage of participants with abnormal Chest X-Ray		Days 1-85	No
Secondary	Overall survival		Baseline up to 5 years	No
Secondary	Disease free survival, according to WHO criteria		Baseline up to 5 years	No