E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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 |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
|
E.2.2 | Secondary objectives of the trial |
Compare Overall Survival (OS) between the two above-mentioned groups Compare toxicity between the two above-mentioned groups. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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)
|
|
E.4 | Principal 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.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
5-year disease-free survival (DFS). |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 7 |
E.8.9.2 | In all countries concerned by the trial months | 6 |