FAC Versus FAC Plus Weekly Paclitaxel as Adjuvant Treatment of Node Negative High Risk Breast Cancer Patients
|ClinicalTrials.gov Identifier: NCT00129389|
Recruitment Status : Unknown
Verified November 2012 by Spanish Breast Cancer Research Group.
Recruitment status was: Active, not recruiting
First Posted : August 11, 2005
Last Update Posted : November 22, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: FAC Drug: paclitaxel||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1929 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||September 2003|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
Active Comparator: 1
FAC X 6
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.
FAC X 4 + 8 Taxol
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).
- Disease-free survival [ Time Frame: 5 years ]
- Overall survival [ Time Frame: 5 years ]
- Toxicity [ Time Frame: During and after chemotherapy completion ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129389
|Spanish Breast Cancer Research Group (GEICAM)|
|San Sebastián de los Reyes, Madrid, Spain, 28700|
|Study Chair:||Miguel Martín, MD., PhD.||Spanish Breast Cancer Research Group (GEICAM)|