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Completed

NCT Number: NCT02846428

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Bayonne, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5-fluorouracil

Drug

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

Drug

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.

Other names: Xeloda

Cyclophosphamide

Drug

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

Drug

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

Drug

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.

Primary outcomes

  1. Percentage of participants with pathological complete tumor response Assessed by Expert Blinded Independent Review according to the Sataloff classification\n

    Time frame: Day 120 +/- 7 days

Secondary outcomes

  1. Percentage of participants with pathological complete tumor response Assessed by Investigator according to the Sataloff classification

    Time frame: Day 120 +/- 7 days

  2. Percentage of participants with breast conserving surgery

    Time frame: Day 120 +/- 7 days

  3. Percentage of participants with objective clinical response, assessed by World Health Organization (WHO) criteria

    Time frame: Week 15

  4. Percentage of participants with clinical response, assessed by WHO criteria

    Time frame: Week 15

  5. Percentage of participants with disease progression, assessed by WHO criteria

    Time frame: Baseline up to 29 +/- 1 weeks

  6. Percentage of participants with abnormalities in bilateral mammography

    Time frame: Day 85

  7. Percentage of participants who died

    Time frame: Baseline up to 29 +/- 1 weeks

  8. Percentage of participants with abnormal left ventricular ejection fraction (LVEF)

    Time frame: Days 1-85

  9. Percentage of participants with abnormal liver ultrasound

    Time frame: Days 1-85

  10. Percentage of participants with abnormal Chest X-Ray

    Time frame: Days 1-85

  11. Overall survival

    Time frame: Baseline up to 5 years

  12. Disease free survival, according to WHO criteria

    Time frame: Baseline up to 5 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2011
Study completion
2011
First posted
Jul 27, 2016
Registry last updated
Jul 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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