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

Alternate Title

Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 to 64	Other	FRE-FNCLCC-PACS-04/0005 EU-20236, NCT00054587

Objectives

1. Compare the efficacy of adjuvant cyclophosphamide, epirubicin, and fluorouracil vs adjuvant docetaxel and epirubicin, in terms of 5-year survival without relapse, in women with nonmetastatic adenocarcinoma of the breast with lymph node invasion.
2. Determine survival of patients treated with these regimens.
3. Compare the tolerability of trastuzumab (Herceptin) in patients treated with these regimens.
4. Determine the efficacy and tolerability of trastuzumab in patients with hormone receptor-positive tumors.
5. Evaluate the quality of life of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed nonmetastatic, unilateral adenocarcinoma of the breast
  • Axillary lymph node invasion (N1, N2, or N3)
  • No cutaneous invasion
  • No T4a or greater disease
• No clinically or radiologically suspected metastases
• No clinically or radiologically suspected contralateral lesion
• No deeply adherent or inflammatory disease
• Complete surgical resection performed, including removal of at least 5 lymph nodes, and with no residual tumor, within the past 42 days
• No prior breast cancer
• Hormone receptor status:
  • Not specified

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• At least 4 weeks since prior chemotherapy
• No other concurrent chemotherapy
• No contraindication to anthracycline therapy

Endocrine therapy

• No prior hormonal therapy

Radiotherapy

• No prior radiotherapy

Surgery

• See Disease Characteristics

Other

• At least 4 weeks since prior experimental therapy

Patient Characteristics:

Age

• 18 to 64

Sex

• Female

Menopausal status

• Not specified

Performance status

• WHO 0-1

Life expectancy

• Not specified

Hematopoietic

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

Hepatic

• ALT and AST no greater than 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase no greater than 2.5 times ULN
• Bilirubin no greater than ULN
• Hepatitis B and hepatitis C negative
• No hepatic dysfunction

Renal

• Creatinine less than 1.3 mg/dL

  OR

• Creatinine clearance greater than 60 mL/min

Cardiovascular

• ECHO normal
• LVEF at least 50%

Pulmonary

• FEV normal
• No dyspnea at rest
• No supplemental oxygen dependence

Other

• Not pregnant
• Fertile patients must use effective contraception
• HIV negative
• No active infection
• No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
• No contraindication to anthracycline therapy
• No chronic medical or psychological condition
• No geographic or social reason that would preclude study therapy

Expected Enrollment

A total of 2,600 patients will be accrued for this study within 3 years.

Outline

This is a randomized, open-label, multicenter study. Patients are stratified according to participating center. Patients are treated in 2 parts.

• Part I: Patients are randomized to 1 of 2 treatment arms.
  • Arm I: Patients receive fluorouracil IV, or epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo radiotherapy 5 days a week for 5 weeks.
  • Arm II: Patients receive epirubicin IV over 10 minutes and docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo radiotherapy as in arm I.

  Patients with HER2/neu-positive tumors then proceed to part II. Patients with HER2/neu-negative tumors receive no further treatment.

  Patients with hormone (estrogen or progesterone) receptor-positive tumors also receive oral tamoxifen daily beginning after chemotherapy is completed and continuing for 5 years.

• Part II: Patients are randomized to 1 of 2 treatment arms.
  • Arm I: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes every 3 weeks for 1 year.
  • Arm II: Patients are followed without treatment.

Patients not receiving trastuzumab are followed at 4 months, 6 months, every 4 months for 1 year, and then every 6 months for 3 years. Patients receiving trastuzumab are followed at 4 months and then every 6 months for 3 years.

Spielmann M, Roché H, Delozier T, et al.: Trastuzumab for Patients With Axillary-Node-Positive Breast Cancer: Results of the FNCLCC-PACS 04 Trial. J Clin Oncol : , 2009.[PUBMED Abstract]

Spielmann M, Roché H, Humblet Y, et al.: 3-year follow-up of trastuzumab following adjuvant chemotherapy in node positive HER2-positive breast cancer patients: results of the PACS-04 trial. [Abstract] Breast Cancer Res Treat 106 (1): A-72, S19, 2007.

Spielmann M, Roché H, Delozier T, et al.: Safety analysis from PACS 04--a phase III trial comparing 6 cycles of FEC100 with 6 cycles of ET75 for node-positive early breast cancer patients, followed by sequential trastuzumab in HER2+patients: preliminary results. [Abstract] J Clin Oncol 24 (Suppl 18): A-632, 2006.

Trial Contact Information

Trial Lead Organizations

Federation Nationale des Centres de Lutte Contre le Cancer

Marc Spielmann, MD, Protocol chair		Ph: 33-1-42-11-43-35

Registry Information
Official Title		Randomized And Multicentric Opened Phase III Study Evaluating The Concomitant Administration Of Docetaxel 75MG/M2 and Epirubicine 75MG/M2 Versus FEC 100 In Non Metastatic With Positive Lymphatic Nodes Breast Cancer Subjects, And The Sequential Addition Of Herceptin In (HER2+++) And (HER2++ And FISH+) Subjects
Trial Start Date		2001-06-02
Registered in ClinicalTrials.gov		NCT00054587
Date Submitted to PDQ		2002-12-20
Information Last Verified		2004-12-02

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