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Clinical Trials/NL-OMON55670
NL-OMON55670CompletedPhase 3

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

ovartis0 sites24 target enrollmentStarted: TBDLast updated:
Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
ovartis
Enrollment
24

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

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

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.

Investigators

Sponsor
ovartis

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