A Study to Investigate the Efficacy and Safety of Letrozole SIE Compared With Femara® (Both Combined With the CDK4/6 Inhibitor Ribociclib) in Postmenopausal Women With HR-Positive, HER2-Negative, Inoperable Locally Advanced or Metastatic Breast Cancer

Sponsor
Rovi Pharmaceuticals Laboratories
Study ID
NCT07340658
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Advanced, Metastatic Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to evaluate the efficacy and safety of Letrozole SIE (injectable) compared to Femara® (oral tablet), both given together with ribociclib, for the first-line treatment of postmenopausal women with HR-positive, HER2-negative, inoperable locally advanced or metastatic breast cancer.

Key Dates

Start date
Aug 31, 2026
Status verified
Mar 2026
Primary completion
Feb 28, 2029
Completion
Dec 31, 2033

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Letrozole SIE
  • Active Comparator: Femara® 2.5 mg

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: From the date of randomization to the date of the first documented progression or death due to any cause, assessed according to RECIST version 1.1 (up to approximately 30 months). ]

Central Contacts