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FAC Versus FAC Plus Weekly Paclitaxel as Adjuvant Treatment of Node Negative High Risk Breast Cancer Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Spanish Breast Cancer Research Group.
Recruitment status was:  Active, not recruiting
ClinicalTrials.gov Identifier:
First Posted: August 11, 2005
Last Update Posted: November 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Bristol-Myers Squibb
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group
August 10, 2005
August 11, 2005
November 22, 2012
September 2003
December 2013   (Final data collection date for primary outcome measure)
Disease-free survival [ Time Frame: 5 years ]
Disease-free survival.
Complete list of historical versions of study NCT00129389 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: 5 years ]
  • Toxicity [ Time Frame: During and after chemotherapy completion ]
  • Overall survival.
  • Toxicity.
  • Quality of life.
  • Prognostic gene profile.
Not Provided
Not Provided
FAC Versus FAC Plus Weekly Paclitaxel as Adjuvant Treatment of Node Negative High Risk Breast Cancer Patients
Multicenter Randomized Phase III Clinical Trial to Compare 6 FAC Cycles(Fluorouracil, Doxorubicin, Cyclophosphamide) vs. 4 FAC Cycles Followed by 8 Weekly Paclitaxel Administrations, as Adjuvant Treatment for Node Negative Operable Breast Cancer Patients

This is a prospective, open-label, randomized, phase III trial. Patients will be stratified after breast surgery, as per investigational site; menopausal status; node negative diagnosis, as per sentinel-node technique versus lymphadenectomy; hormone receptor status (positive versus negative). Patients will be randomized to:

  • FAC x 6 (cycles): 5-fluorouracil 500 mg/m2 + doxorubicin 50 mg/m2 + cyclophosphamide 500 mg/m2 day 1, every 3 weeks, for 6 cycles.
  • FAC x 4 (cycles) → Taxol® x 8 (cycles): 5-fluorouracil 500 mg/m2 + doxorubicin 50 mg/m2 + cyclophosphamide 500 mg/m2 day 1, every 3 weeks, for 4 cycles, followed by 8 administrations of weekly paclitaxel 100 mg/m2

Premenopausal women with hormone receptor positive tumors must receive tamoxifen 20 mg daily for 5 years, after the end of chemotherapy.

Postmenopausal women with hormone receptor positive tumors are allowed to receive aromatase inhibitors as initial adjuvant hormone therapy or after tamoxifen.

All patients with breast conservative surgery must receive radiotherapy.

Estimated 5-year disease-free survival in the control arm (FAC x 6) is expected to be 80%. It is expected that disease-free survival will increase by 5% in the experimental arm (FAC-paclitaxel). 906 patients per arm must be recruited, to detect this difference with an alpha error of 0.05 and 80% power. Assuming a 6% post-randomization drop-out rate, 960 patients per arm are needed, 1920 in total.

Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • Drug: FAC
    FAC x 6: 5-fluorouracil 500 mg/m2 i.v. + doxorubicin 50 mg/m2 i.v. + cyclophosphamide 500 mg/m2 i.v. every 3 weeks, for 6 cycles.
  • Drug: paclitaxel

    FAC x 4 -> Taxol x 8:

    5-fluorouracil 500 mg/m2 i.v. + doxorubicin 50 mg/m2 i.v. + cyclophosphamide 500 mg/m2 i.v. every 3 weeks, for 4 cycles followed by weekly Taxol 100 mg/ m2 for 8 cycles (days 1, 8, 15, 22, 29, 36, 43 y 50).

  • Active Comparator: 1
    FAC X 6
    Intervention: Drug: FAC
  • Experimental: 2
    FAC X 4 + 8 Taxol
    Intervention: Drug: paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
December 2013
December 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Written informed consent.
  • Histological diagnoses of operable invasive adenocarcinoma of the breast (T1-T3). Tumors must be HER2 negative. Patients must be free of disease in the axilla (node negative). If lymphadenectomy is done, at least 10 nodes must be examined. If sentinel node technique is used, sentinel node must be free of disease. Patients must present at least one high risk criterion (St. Gallen, 1998) as follows:

    • Tumor size > 2 cm; and/or
    • ER and PgR negative; and/or
    • Histological grade 2-3; and/or
    • Age < 35 years old.
  • Time window between surgery and study randomization must be less than 60 days.
  • Surgery must consist of mastectomy or conservative surgery. Margins free of disease and ductal carcinoma in situ (DCIS) are required. Lobular carcinoma is not considered a positive margin.
  • Patients must not present evidence of metastatic disease.
  • Status of hormone receptors in primary tumor. Results must be available before the end of adjuvant chemotherapy.
  • Status of HER2 in primary tumor, known before randomization. Patients with immune histochemistry (IHC) 0 or +1 are eligible. For patients with ICH 2+, fluorescent in situ hybridization (FISH) is mandatory and result must be negative.
  • Age >= 18 and <= 70 years old.
  • Performance status (Karnofsky index) >= 80.
  • Normal electrocardiogram (EKG) in the 12 weeks prior to randomization. If needed, normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF).
  • Laboratory results (within 14 days prior to randomization):

    • Hematology: neutrophils >= 1.5 x 10^9/l; platelets >= 100x 10^9/l; hemoglobin >= 10 mg/dl;
    • Hepatic function: total bilirubin <= 1 upper normal limit (UNL); SGOT and SGPT <= 2.5 UNL; alkaline phosphatase <= 2.5 UNL. If values of SGOT and SGPT > 1.5 UNL are associated with alkaline phosphatase > 2.5 UNL, patient is not eligible.
    • Renal function: creatinine <= 175 mmol/l (2 mg/dl); creatinine clearance >= 60 ml/min.
  • Complete stage workup during the 12 weeks prior to randomization (mammograms are allowed within a 20 week time window). All patients must have a bilateral mammogram, thorax x-ray, abdominal echography and/or computed tomography (CT)-scan. If bone pain, and/or alkaline phosphatase elevation, a bone scintigraphy is mandatory. This test is recommended for all patients. Other tests, as clinically indicated.
  • Patients able to comply with treatment and study follow-up.
  • Negative pregnancy test done in the 14 previous days to randomization.

Exclusion Criteria:

  • Prior systemic therapy for breast cancer.
  • Prior therapy with anthracyclines or taxanes (paclitaxel or docetaxel) for any malignancy.
  • Prior radiotherapy for breast cancer.
  • Bilateral invasive breast cancer.
  • Pregnant or lactating women. Adequate contraceptive methods must be used during chemotherapy and hormone therapy treatments. Negative pregnancy test in the 14 previous days to randomization.
  • Any T4 or N1-3 or M1 tumor.
  • HER2 positive breast cancer (IHC 3+ or positive FISH result).
  • Pre-existing grade >=2 motor or sensorial neurotoxicity (National Cancer Institute Common Toxicity Criteria [NCI CTC] v-2.0).
  • Any other serious medical pathology, such as congestive heart failure, unstable angina, history of myocardial infarction during the previous year, uncontrolled HA or high risk arrhythmias.
  • History of neurological or psychiatric disorders, which could preclude the patients to free informed consent.
  • Active uncontrolled infection.
  • Active peptic ulcer; unstable diabetes mellitus.
  • Previous or current history of neoplasms different from breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumor curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma.
  • Concomitant treatment with other investigational products. Participation in other clinical trials with a non-marketed drug in the 20 previous days before randomization.
  • Concomitant treatment with other therapy for cancer.
  • Males.
Sexes Eligible for Study: Female
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
GEICAM 2003-02
Not Provided
Not Provided
Spanish Breast Cancer Research Group
Spanish Breast Cancer Research Group
Bristol-Myers Squibb
Study Chair: Miguel Martín, MD., PhD. Spanish Breast Cancer Research Group (GEICAM)
Spanish Breast Cancer Research Group
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP