Advanced breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
Capsules containing 20 mg and 100 mg of S 78454 / oral use / 120 mg b.i.d to 160 mg b.i.d (dose de-escalation up to 80 mg b.i.d can be performed), and
Fixed dose of tamoxifen 20 mg per
Sponsors
Pharmacyclics LLC (USA)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female patients aged 18 years or over 2. Ability to swallow oral capsule(s) 3. Estimated life expectancy > 12 weeks 4. ECOG performance status less than or equal to 1 5. Adequate haematological and hepatic functions 6. Histologically confirmed primary adenocarcinoma of the breast 7. Patients whose tumor has significant expression of Estrogen Receptor 8. Absence of Human Epidermal Growth Factor Receptor-2 overexpression or amplification
Exclusion criteria
Exclusion criteria: 1. Major surgery within previous 4 weeks 2. Any previous chemotherapy within 3 weeks (6 weeks in case of nitroso-ureas) before starting the study drug 3. Any radiotherapy within previous 4 weeks (except for palliative radiotherapy at localised lesions) 4. Any other prior therapy directed at breast cancer within previous 3 weeks, including biologic/targeted therapy or immunologic agents 5. Hormonotherapy within 2 weeks, except stable oral glucocorticoid and mineralocorticoid replacement for adrenal insufficiency, topical corticosteroids (e.g. cream, spray) 6. Concomitant uncontrolled infection or systemic disease 7. Known endometrial hyperplasia, or endometrial cancer 8. Patients with prior thromboembolic events or at high risk of such events 9. Rapidly progressive visceral, central nervous system, or liver metastases or significant symptomatic lymphangitic pulmonary metastases 10. Patients with pre-existing gastrointestinal disorders (including significant malabsorption syndrome, significant chronic digestive or gastrointestinal inflammatory syndrome, gastroduodenal disorders at risk for bleeding) that might interfere with proper absorption of the oral drugs 11. Patients with impaired cardiac function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Dose limiting toxicities and maximum tolerated doses at the end of cycle 2. Methods used: blood samples, physical examination, vital signs assessment, ECG 2. Safety profile of the combination at each visit (adverse events, laboratory tests, physical examination, ECOG, vital signs, ECG) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pharmacokinetic evaluation within cycle 2 by blood samples 2. Pharmacodynamic assessment every cycle by blood samples 3. Tumour response evaluation every two cycles according to RECIST criteria | — |
Countries
France, Italy, Spain
Outcome results
None listed