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Sponsors and Collaborators: |
Spanish Breast Cancer Research Group Bristol-Myers Squibb |
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Information provided by: | Spanish Breast Cancer Research Group |
ClinicalTrials.gov Identifier: | NCT00129389 |
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:
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 | Intervention | Phase |
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Breast Cancer |
Drug: paclitaxel |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
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 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Laboratory results (within 14 days prior to randomization):
Exclusion Criteria:
Contact: Miguel Martín, MD., PhD. | mmartin@geicam.org |
Spain, Madrid | |
Spanish Breast Cancer Research Group (GEICAM) | Recruiting |
San Sebastián de los Reyes, Madrid, Spain, 28700 | |
Contact: Esther Mahillo, PhD ´+34916592870 emahillo@geicam.org | |
Principal Investigator: Ana Lluch | |
Principal Investigator: Miguel Martín | |
Principal Investigator: Lourdes Calvo | |
Principal Investigator: Amparo Ruiz | |
Principal Investigator: Sonia González | |
Principal Investigator: Agustí Barnadas | |
Principal Investigator: Mireia Margelí | |
Principal Investigator: Álvaro Rodríguez-Lescure | |
Principal Investigator: Miguel A Seguí | |
Principal Investigator: Monserrat Muñoz | |
Principal Investigator: Antonio Antón | |
Principal Investigator: Manuel Ruiz-Borrego | |
Principal Investigator: Ramón Colomer | |
Principal Investigator: Enrique Espinosa | |
Principal Investigator: José Manuel López.Vega | |
Principal Investigator: Pedro Sánchez-Rovira | |
Principal Investigator: César A Rodríguez | |
Principal Investigator: Nuria Ribelles | |
Principal Investigator: Encarna Adrover | |
Principal Investigator: Blanca Munárriz | |
Principal Investigator: Carmen Crespo | |
Principal Investigator: Raquel Andrés | |
Principal Investigator: Manuel Ramos | |
Principal Investigator: Javier Salvador | |
Principal Investigator: Adolfo Frau | |
Principal Investigator: César Mendiola | |
Principal Investigator: José R Mel-Lorenzo | |
Principal Investigator: José I Chacón | |
Principal Investigator: Arrate Plazaola | |
Principal Investigator: Carlos Jara | |
Principal Investigator: Rosa Mª Franquesa | |
Principal Investigator: Juan de la Haba | |
Principal Investigator: José M Baena | |
Principal Investigator: Amparo Oltra | |
Principal Investigator: Alberto Arcediano del Amo | |
Principal Investigator: Angela Arcusa | |
Principal Investigator: Miguel Méndez | |
Principal Investigator: Amalia Velasco | |
Principal Investigator: José Alés | |
Principal Investigator: Francisco J Carabantes | |
Principal Investigator: Severina Domínguez | |
Principal Investigator: Vicente Carañana | |
Principal Investigator: Alfonso Modolell | |
Principal Investigator: Ricardo Cubedo | |
Principal Investigator: Mª José García | |
Principal Investigator: Jesús García-Girón | |
Principal Investigator: Jesús Florián | |
Principal Investigator: Antonio Fernández-Aramburo | |
Principal Investigator: Norberto Batista | |
Principal Investigator: Alberto Arizcum | |
Principal Investigator: Adolfo Murias | |
Principal Investigator: Jesús García-Mata | |
Principal Investigator: Isabel Álvarez | |
Principal Investigator: Ana Mª Miguel | |
Principal Investigator: Cristina Martín | |
Principal Investigator: Amadeu Pelegrí | |
Principal Investigator: José V Álvarez |
Study Chair: | Miguel Martín, MD., PhD. | Spanish Breast Cancer Research Group (GEICAM) |
Study ID Numbers: | GEICAM 2003-02 |
Study First Received: | August 10, 2005 |
Last Updated: | September 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00129389 |
Health Authority: | Spain: Spanish Agency of Medicines |
Node negative, high risk breast cancer. Prognostic gene profile. Saint Gallen high risk criteria. Weekly paclitaxel. |
Skin Diseases Paclitaxel Fluorouracil Breast Neoplasms |
Cyclophosphamide Doxorubicin Breast Diseases |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Antimitotic Agents Antibiotics, Antineoplastic Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents |