Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Spanish Breast Cancer Research Group Coalición Iberoamericana de Investigación en Oncología Mamaria (CIBOMA) Hoffmann-La Roche |
---|---|
Information provided by: | Spanish Breast Cancer Research Group |
ClinicalTrials.gov Identifier: | NCT00130533 |
This is a prospective, open-label, randomized phase III study. Patients will be stratified as per investigational site, previous adjuvant chemotherapy (anthracyclines versus anthracyclines plus taxanes), and number of affected axillary lymph nodes (0, 1-3, >= 4). Node negative patients must present a tumour size > 2 cm to be eligible. At least 6 lymph nodes must be analysed to confirm the number of affected nodes. Patients will be randomised to receive: 8 courses of capecitabine 1000 mg/m2 by mouth, twice a day (p.o. bid) for 14 days, followed by a 7 day rest versus observation.
Tissue samples must be analysed by a central laboratory, to confirm estrogen receptor (ER), progesterone receptor (PgR), human epidermal growth factor receptor-2 (HER2), cytokeratins CK 5/6 and epidermal growth factor receptor (EGFR) status.
The researchers assume that 5-year disease-free survival in the control arm will be 64.72%. To detect a decrease in risk ratio of 25%, with alpha error = 0.05 and 80% of power, 379 events are required.
Assuming 10% post-randomization drop-outs, 1324 patients must be enrolled, 662 per treatment arm.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: capecitabine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | Multicenter, Open-Label, Randomized Phase III Trial, to Evaluate Efficacy of Maintenance Treatment With Capecitabine (X) Following Standard Adjuvant Chemotherapy, in Operable Breast Cancer Patients With Negative Hormone Receptor, Negative HER2 Tumours |
Estimated Enrollment: | 1324 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | January 2008 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Hematology:
Hepatic function:
Renal Function:
Pharmacogenetics:
Exclusion Criteria:
Contact: Ana Lluch | lluch_ana@gva.es |
Spain, Madrid | |
Coalición Iberoamericana de Investigación en Oncología Mamaria (CIBOMA) | Recruiting |
San Sebastián de los Reyes, Madrid, Spain, 28700 | |
Contact: Esther Mahillo, PhD +34916592870 emahillo@ciboma.org | |
Principal Investigator: Henry Gómez | |
Principal Investigator: Ana Lluch | |
Principal Investigator: Laura Torrecillas | |
Principal Investigator: Carlos H Barrios | |
Principal Investigator: Miguel Martín | |
Principal Investigator: José I Mayordomo | |
Principal Investigator: César Mendiola | |
Principal Investigator: Carlos Jara, MD., PhD | |
Principal Investigator: Ignacio Tusquets, MD., PhD | |
Principal Investigator: Manuel Ramos, MD., PhD | |
Principal Investigator: Manuel Ruiz, MD., PhD | |
Principal Investigator: Pedro Sánchez, MD., PhD | |
Principal Investigator: José Enrique Alés, MD., PhD | |
Principal Investigator: Jesús Florián, MD., PhD | |
Principal Investigator: José Manuel Baena, MD., PhD | |
Principal Investigator: Javier Cassinello, MD., PhD | |
Principal Investigator: Miguel Angel Seguí, MD., PhD | |
Principal Investigator: Agustín Barnadas, MD., PhD | |
Principal Investigator: Angels Arcusa, MD., PhD | |
Principal Investigator: José Ramón Mel, MD., PhD | |
Principal Investigator: César Rodríguez, MD., PhD | |
Principal Investigator: Laura G. Estévez, MD., PhD | |
Principal Investigator: Mireia Margelí, MD., PhD | |
Principal Investigator: Álvaro Rodríguez, MD., PhD | |
Principal Investigator: José Manuel Lopez, MD., PhD | |
Principal Investigator: José Valero Álvarez, MD., PhD | |
Principal Investigator: Encarnación González, MD., PhD | |
Principal Investigator: Laura Perez | |
Principal Investigator: Daniel Capdeville | |
Principal Investigator: Paula Cabrera | |
Principal Investigator: Álvaro Guerrero | |
Principal Investigator: Alejo Jiménez | |
Principal Investigator: Fernando Checa | |
Principal Investigator: Jorge Moncayo | |
Principal Investigator: Diana Sosa | |
Principal Investigator: Manuel Roberto Torres | |
Principal Investigator: Mónica Campos | |
Principal Investigator: José Getulio Martins |
Study Chair: | Ana Lluch | Coalición Iberoamericana de Investigación en Oncología Mamaria (CIBOMA) |
Study Chair: | Laura Torrecillas | Coalición Iberoamericana de Investigación en Oncología Mamaria (CIBOMA) |
Study Chair: | Carlos H Barrios | Coalición Iberoamericana de Investigación en Oncología Mamaria (CIBOMA) |
Study ID Numbers: | CIBOMA 2004-01 |
Study First Received: | August 12, 2005 |
Last Updated: | September 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00130533 |
Health Authority: | Spain: Spanish Agency of Medicines |
Maintenance chemotherapy treatment. Basal-like genotype. |
Capecitabine Skin Diseases Breast Neoplasms Breast Diseases |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |