Study of LEE011 with fulvestrant and BYL719 or BKM120 in advanced breast cancer

Phase 1

• Conditions: Breast CancerHormone receptor positive, HER2 negative; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-004587-65-GB
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-20
• Study Completion: 2018-04-17
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

- Postmenopausal, Hormone receptor positive (HR+), HER2 negative breast cancer;
- Phase Ib - Unlimited number of lines of endocrine therapy and up to two lines of cytotoxic chemotherapy in the metastatic setting.
- Phase II - Unlimited number of lines of endocrine therapy and one line of
cytotoxic chemotherapy in the metastatic setting
Other protocol-defined inclusioncriteria may apply
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 216
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 173

Exclusion Criteria

- HER2-overexpression in the patient's tumor tissue;
- inadequate bone marrow function or evidence of end-organ damage;
- severe or uncontrolled medical issues;
- diabetes mellitus.
Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified