Not Yet Recruiting PHASE3 INTERVENTIONAL 2-arm NCT07340658

A Study to Investigate the Efficacy and Safety of Letrozole SIE Compared With Femara® (Both Combined With the CDK4/6 Inhibitor Palbociclib) in Postmenopausal Women With HR-Positive, HER2-Negative, Advanced Breast Cancer (SIE-3)

A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase III Study to Evaluate the Efficacy and Safety of Letrozole SIE Compared to Femara® (Both in Combination With the CDK4/6 Inhibitor Palbociclib) in Postmenopausal Women With HR-Positive, HER2-Negative, Inoperable Locally Advanced or Metastatic Breast Cancer (SIE-3)

Sponsor: Rovi Pharmaceuticals Laboratories

Conditions Advanced, Metastatic Breast Cancer

Interventions Letrozole SIE + Palbociclib + Oral placebo Oral Femara® + Palbociclib + Injectable placebo

Updated 1 time since 2026 Last updated: Jan 13, 2026 Started: May 31, 2026 Primary completion: Feb 28, 2029 Completion: Jun 30, 2031

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Advanced, Metastatic Breast Cancer and is currently actively recruiting participants. Rovi Pharmaceuticals Laboratories leads this study, which shows 1 recorded version since 2026 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

Change History

1 version recorded

Not Yet Recruiting — PHASE3 [monthly]

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Rovi Pharmaceuticals Laboratories

Data source: Rovi Pharmaceuticals Laboratories

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.