Phase I study of S 78454 with tamoxifen 20 mg in patients with breast cancer

Phase 1

Completed

• Conditions: Advanced breast cancer; Cancer; Malignant neoplasm of breast

• Registration Number: ISRCTN25889030
• Lead Sponsor: Pharmacyclics LLC (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-29
• Study Completion: 2015-01-28
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified