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Clinical Trials (PDQ®)

  • Last Modified: 3/28/2012

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Clinical Trials (PDQ®)

Phase III Comparison of Preoperative vs Postoperative FEC (Fluorouracil/Epirubicin/Cyclophosphamide) in Women with Operable Breast Cancer

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Alternate Title

Combination Chemotherapy Before or After Surgery in Treating Women With Breast Cancer

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed16 to 70EORTC-10902

Objectives

I.  Determine whether 4 courses of preoperative chemotherapy with FEC 
(fluorouracil/epirubicin/cyclophosphamide) in women with operable breast 
cancer reduce the tumor size sufficiently to permit breast-conserving surgery 
in patients for whom mastectomy is initially planned.

II.  Compare disease-free and overall survival of women with operable breast 
cancer randomly assigned to 4 courses of FEC administered preoperatively vs. 
postoperatively (beginning within 36 hours of surgery).

III.  Evaluate the response of the primary tumor to preoperative chemotherapy 
and determine the correlation between this response and disease-free and 
overall survival.

Entry Criteria

Disease Characteristics:


Palpable, operable breast cancer that has been diagnosed by core needle biopsy
(mandatory for T1c tumors) or fine needle aspiration within 21 days prior to
entry

Stage T1c-4b, N0-1, M0

Hormone receptor status:
  Not specified

No bilateral breast cancer


Prior/Concurrent Therapy:


No previous treatment for breast cancer

Biologic therapy:
  Not specified

Chemotherapy:
  No previous chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  Not specified

Surgery:
  Core needle biopsy or fine needle aspiration within 21 days prior to entry
  Repeated core needle biopsy permitted


Patient Characteristics:


Age:
  16 to 70

Sex:
  Women only

Menopausal status:
  Not specified

Performance status:
  WHO 0-2

Hematopoietic:
  WBC at least 4,000
  Platelets at least 100,000

Hepatic:
  Bilirubin no greater than 2.8 mg/dL (50 micromoles/L)

Renal:
  Creatinine no greater than 1.3 mg/dL (120 micromoles/L)

Cardiovascular:
  No congestive heart failure
  No significant arrhythmia
  No bilateral bundle branch block
  No recent myocardial infarction
  No uncontrolled hypertension (diastolic pressure greater than 110 mm Hg)

Other:
  No male breast cancer
  No pregnant or nursing women
  No second malignancy except adequately treated:
      Nonmelanomatous skin cancer
      Cervical cancer


Expected Enrollment

1,100 evaluable patients will be entered on each treatment arm over 
approximately 4 years.

Outline

This is a randomized study.  Patients are stratified by participating 
institution, clinical tumor size, clinical nodal status, age, and planned 
surgical treatment.

The first group receives fluorouracil, epirubicin, and cyclophosphamide (FEC) 
every 3 weeks for a total of 4 courses, followed 3 weeks later by surgery.  
Radiotherapy for patients who undergo less than a mastectomy begins 2-4 weeks 
after completion of chemotherapy

The second group undergoes breast-conserving surgery followed, within 24-36 
hours, by chemotherapy with FEC as above.  Radiotherapy for patients who 
undergo less than a mastectomy begins after surgery.

All patients aged 50 years and older are given oral tamoxifen daily for at 
least 2 years, beginning 15 weeks after initiation of therapy.

Patients are followed every 4 months for 2 years, every 6 months for up to 5 
years, and annually thereafter.

Published Results

van Nes JG, Putter H, Julien JP, et al.: Preoperative chemotherapy is safe in early breast cancer, even after 10 years of follow-up; clinical and translational results from the EORTC trial 10902. Breast Cancer Res Treat 115 (1): 101-13, 2009.[PUBMED Abstract]

Mieog JS, van der Hage JA, van de Vijuer MJ, et al.: Tumour response to preoperative anthracycline-based chemotherapy in operable breast cancer: the predictive role of p53 expression. Eur J Cancer 42 (10): 1369-79, 2006.[PUBMED Abstract]

van der Hage JA, van de Velde CJ, Julien JP, et al.: Preoperative chemotherapy in primary operable breast cancer: results from the European Organization for Research and Treatment of Cancer trial 10902. J Clin Oncol 19 (22): 4224-37, 2001.[PUBMED Abstract]

Related Publications

Tanis E, van de Velde CJ, Bartelink H, et al.: Locoregional recurrence after breast-conserving therapy remains an independent prognostic factor even after an event free interval of 10 years in early stage breast cancer. Eur J Cancer 48 (12): 1751-6, 2012.[PUBMED Abstract]

van der Hage JA, Mieog JS, van de Velde CJ, et al.: Impact of established prognostic factors and molecular subtype in very young breast cancer patients: pooled analysis of four EORTC randomized controlled trials. Breast Cancer Res 13 (3): R68, 2011.[PUBMED Abstract]

de Bock GH, Putter H, Bonnema J, et al.: The impact of loco-regional recurrences on metastatic progression in early-stage breast cancer: a multistate model. Breast Cancer Res Treat 117 (2): 401-8, 2009.[PUBMED Abstract]

Van Nes JGH, Putter H, Bartelink H, et al.: A prognostic index for local recurrences in women with early breast cancer using European Organization for Research and Treatment of Cancer (EORTC) studies. [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-2021, S86-7, 2006.

de Bock GH, van der Hage JA, Putter H, et al.: Isolated loco-regional recurrence of breast cancer is more common in young patients and following breast conserving therapy: long-term results of European Organisation for Research and Treatment of Cancer studies. Eur J Cancer 42 (3): 351-6, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Michelle Tubiana-Hulin, MD, Protocol chair
Ph: 33-1-47-111-515

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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