A randomized double-blind, placebo-controlled study of LEE011 in combination with letrozole for the treatment of postmenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer who received no prior therapy for advanced disease (CLEE011A2301)

A randomized double-blind, placebo-controlled study of LEE011 in combination with letrozole for the treatment of postmenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer who received no prior therapy for advanced disease (CLEE011A2301) - CLEE011A2301 - MONALEESA-2

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55670

Enrollment

Registered

2014-01-07

Start date

2014-06-06

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced breast cancer

Interventions

Treatment with letrozole with or without LEE.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Women >=18 years old, with advanced breast cancer. • No prior therapy for advanced disease • Postmenopausal. See protocol page 34 for details. • Confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive, HER2 negative breast cancer. • Measurable disease or at least one predominantly lytic bone lesion. • ECOG performance status 0 or 1. • Adequate bone marrow and organ function (based on central lab)

Exclusion criteria

Exclusion criteria: • Received any CDK4/6 inhibitor. • Any prior systemic anti-cancer therapy (including hormonal therapy and chemotherapy) for advanced breast cancer. See protocol page 45 for details. • Known history of HIV infection (testing not mandatory). • Patient has CNS metastases • Active cardiac disease or a history of cardiac dysfunction. See protocol page 46 for details. • Prohibited medication. See protocol page 36 for details.

Design outcomes

Primary

Measure	Time frame
Progression free survival.	—

Secondary

Measure	Time frame
Overall survival, response, clinical benefit, ECOG performance status, side-effects, result quality of life questinnaires.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)