E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
early breast cancer in elderly patients or patients who are unfit for a polychemotherapy regimen |
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E.1.1.1 | Medical condition in easily understood language |
early breast cancer in elderly patients or patients who are unfit for a polychemotherapy regimen |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10006190 |
E.1.2 | Term | Breast cancer invasive NOS |
E.1.2 | System Organ Class | 100000004864 |
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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 |
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E.2.2 | Secondary objectives of the trial |
• To evaluate Physical function using the Vulnerable Elders Survey (VES-13). • To describe cognitive function by using the Mini-Cog • To evaluate Fatigue by using the Brief Fatigue Inventory (BFI) . • To compare the Charlson Index versus the Cumulative Illness Rating Scale (CIRS) in all patients. • Breast cancer free interval (BCFI) • Overall survival (OS)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Women 65 years of age or older, Performance status (ECOG) 0-2, Charlson Scale ≤ 2, or Women 64 years or younger, who SHOULD receive an adjuvant chemotherapy according to the 2011 St Gallen Guidelines but who are NOT candidates to a 3-weekly taxane- and anthracycline-based regimen, Performance status (ECOG) 0-2 , Charlson Scale ≤ 2 Operable, histologically confirmed adenocarcinoma of the breast Tumor diameter > 1 cm The tumor must be confined to the breast and axillary nodes without detected metastases elsewhere. Patients with synchronous (diagnosed histologically within 2 months) bilateral invasive breast cancer are eligible if all other criteria are met. Patients must have had surgery for primary breast cancer with no known clinical residual loco-regional disease. Margins must be negative for invasive breast cancer and DCIS. Patients should be randomized and start treatment as close to definitive surgery as possible; within 6 weeks is recommended and not more than 12 weeks (from last surgery in case of bilateral breast cancer).
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E.4 | Principal exclusion criteria |
Patients with locally advanced inoperable breast cancer including inflammatory breast cancer, supraclavicular node involvement, or enlarged internal mammary nodes (unless pathologically negative). Patients with a history of any prior ipsilateral or contralateral invasive breast cancer. Patients with previous or concomitant malignancy diagnosed within the past five years. Patients with adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, contra- or ipsilateral in situ breast carcinoma are eligible regardless of the date of diagnosis. Patients with other non-malignant uncontrolled systemic diseases that would preclude trial entry in the opinion of the investigator. Specifically not eligible are patients with uncontrolled active infection, chronic infection such as active HBV or HCV. Patients with myocardial infarction, pulmonary embolism or deep venous thrombosis within 6 months prior to randomization. Patients with at least one of the so-called “geriatric syndromes”: dementia, delirium, major depression (as diagnosed by a psychiatrist), recent falls, spontaneous bone fractures, neglect, and abuse.
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
monthly during treatment (first 4 months), then every 6 months up to 5 years |
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E.5.2 | Secondary end point(s) |
- Adverse events - Tolerability - Patient-rated Quality of Life (QL) assessments (Global Quality of Life form (GQL) and Symptom Specific QL form, SSQL) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
monthly during treatment (first 4 months), then every 6 months up to 5 years |
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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 | No |
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 | No |
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) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |