Patients with operated breast cancer with no metastatic involvement (AJCC, 2002). Patients will be able to participate whether they present axillary node involvement (node positive) or not (node negative). Node-negative patients must have a tumor of at least 2 cm diameter.At least six axillary nodes must be studied. The patients’ tumors must be estrogen and progesterone receptor negative and HER2 negative, according to the determination of the designated central laboratory
Conditions
Interventions
Trade Name: XELODA
Product Name: XELODA
Product Code: capecitabine
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: CAPECITABINA
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
COALICIÓN IBEROAMERICANA DE INVESTIGACIÓN EN ONCOLOGÍA MAMARIA (CIBOMA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Informed consent must be obtained and documented in writing before any protocol-specific procedures are performed. Information must be included on the expected cooperation of patients in treatment and follow-up, in accordance with the ICH guidelines for Good Clinical Practice. The patient must sign informed consent for sending her tumor sample to the central laboratory. Subsequently, if the patient is eligible, a consent form must be signed for participation in the clinical trial. - Histologically-proven breast cancer (histological examination: invasive adenocarcinoma). - Patients with axillary node involvement. If the sentinel node technique is used, the sentinel node will count as a resected involved node. Patients who can be classified in the following groups (AJCC 2002) will be admitted: · pN1a: Metastasis in 1 to 3 axillary nodes · pN2a: Metastasis in 4 to 9 axillary nodes (at least one tumor deposit >0.2 cm)· pN3a: Metastasis in 10 or more axillary nodes (at least one tumor deposit >0.2 cm). Patients with a diagnosis of pN3a with infraclavicular node metastasis will not be eligible - Age >18 years. - Karnofsky performance status >80 (ECOG 0,1) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Previous treatment with anthracyclines or taxanes (paclitaxel, docetaxel) for any neoplasm other than the breast cancer being treated. - Pregnant or nursing patients. Patients of child-bearing potential must use appropriate non-hormonal contraceptives during the study (chemotherapy and observation), and must have a negative result in a urine pregnancy test with the 14 days before treatment assignation. - Diagnosis of breast cancer of any T4 or M1 category, invasive bilateral breast cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Principal objective: Compare 5-year disease-free survival after maintenance therapy with 8 cycles of capecitabine (X) compared to observation, in patients with operable, hormone receptor and HER2neu negative breast cancer who have received standard adjuvant chemotherapy;Secondary Objective: Compare Overall Survival (OS) between the two above-mentioned groups Compare toxicity between the two above-mentioned groups.;Primary end point(s): 5-year disease-free survival (DFS). | — |
Countries
Spain
Outcome results
None listed