Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy Compared With Observation After Surgery in Treating Women With Relapsed Nonmetastatic Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 18 to 65 Other FRE-FNCLCC-PACS-03/003 EU-20237, NCT00053911

Objectives

1. Compare the efficacy of adjuvant cyclophosphamide, epirubicin, and fluorouracil vs observation, in terms of disease-free 5-year survival, in women who have undergone resection for relapsed nonmetastatic breast cancer after initial conservative surgery.
2. Compare the overall survival of women treated with these regimens.
3. Determine the tolerance of these women to the chemotherapy regimen.
4. Correlate prognostic factors of survival with efficacy of the chemotherapy regimen in these women.

Entry Criteria

Disease Characteristics:

• Histologically confirmed adenocarcinoma of the breast
  • No contralateral breast cancer



• Local tumor recurrence more than 6 months after conservative surgery



• Complete or conservative resection of the recurrent tumor

   [Note: Initial complete surgical resection not allowed]




• No local inflammatory disease or disease that is not amenable to complete surgical resection



• No positive axillary lymph nodes



• No distant metastases, including subclavicular lymph nodes



• Hormone receptor status:
  • Hormone receptor status known

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• See Patient Characteristics-Other
• No prior neoadjuvant chemotherapy

Endocrine therapy

• No prior neoadjuvant hormonal therapy

Radiotherapy

• No prior neoadjuvant radiotherapy

Surgery

• See Disease Characteristics
• At least 41 days since prior surgery

Patient Characteristics:

Age

• 18 to 65

Sex

• Female

Menopausal status

• Menopausal status known

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Neutrophil count at least 2,000/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin no greater than upper limit of normal (ULN)
• Transaminases no greater than 1.5 times ULN
• Alkaline phosphatase no greater than 2.5 times ULN
• No chronic hepatitis B
• No active hepatitis C

Renal

• Not specified

Cardiovascular

• Cardiac function normal by echocardiogram or isotopes

Other

• No contraindications to anthracyclines such as any of the following:
  • Prior doxorubicin over 300 mg/m²
  • Prior epirubicin over 600 mg/m²
  • Prior mitoxantrone over 90 mg/m²
• No other invasive malignancy
• No chronic somatic or psychiatric condition that would preclude study participation
• No familial, social, geographic, or psychological reason that would preclude study participation
• Not pregnant
• Fertile patients must use effective contraception
• HIV negative
• CA 153 no greater than 2 times ULN

Expected Enrollment

A total of 370 patients (185 per treatment arm) will be accrued for this study within 3 years.

Outline

This is a randomized, multicenter study. Patients are stratified according to menopausal status and participating center. Patients are randomized to 1 of 2 treatment arms. Study begins within 42 days after resection of recurrent disease.

• Arm I: Patients receive fluorouracil IV over 1 hour, epirubicin IV over 1 hour, and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.



• Arm II: Patients are examined on days 1 and 63.

Patients who are hormone receptor positive also receive one of the following hormonal therapy regimens, depending on menopausal status:

• Oral tamoxifen daily for 5 years



• Oral tamoxifen daily for 5 years and oral luteinizing hormone-releasing hormone (LHRH) agonist therapy (e.g., goserelin) for 3 years



• Oral LHRH agonist therapy (e.g., goserelin) for 3 years



• Oral antiaromatase therapy (e.g., anastrozole) for 5 years

Patients also undergo radiotherapy and may also undergo second complete resection.

Patients are followed every 6 months for 5 years and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Federation Nationale des Centres de Lutte Contre le Cancer

Gilles Romieu, MD, Protocol chair		Ph: 33-4-67-613-151

Registry Information
Official Title		Randomized And Multicentric Phase III Study Evaluating The Benefit By Using A Chemotherapy With FEC 100 And Docetaxel In Non Metastatic Breast Cancer Which Has Relapsed After A Conservative Surgery
Trial Start Date		2002-11-13
Registered in ClinicalTrials.gov		NCT00053911
Date Submitted to PDQ		2002-12-09
Information Last Verified		2005-01-27

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