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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

ConditionAdvanced, Metastatic Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRovi Pharmaceuticals Laboratories

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female participants with inoperable locally advanced or metastatic breast cancer.

Confirmed diagnosis of HR-positive/HER2-negative breast cancer.

Postmenopausal woman.

Previously untreated with any systemic anticancer therapy for their locoregionally recurrent or metastatic HR-positive disease. Participants may have received cytotoxic chemotherapy within (neo) adjuvant previous treatment of breast cancer but must show progressive disease prior to enrollment.

Disqualifiers

Participants with advanced, symptomatic, visceral spread who are at risk of life-threatening complications in the short term.

Participants with inflammatory breast cancer.

Known uncontrolled or symptomatic central nervous system (CNS) metastases.

Concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated basal or squamous cell carcinoma, non-melanomatous skin cancer, or curatively resected cervical cancer.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Letrozole SIE + Ribociclib + Oral placebo

    Drug

    Letrozole SIE quarterly (injectable) + Ribociclib once daily (oral) + placebo once daily (oral)

  • Oral Femara® + Ribociclib + Injectable placebo

    Drug

    Femara® 2.5 mg/day (oral) + Ribociclib once daily (oral) + placebo quarterly (injectable)

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Letrozole SIEExperimental treatment 1 intervention
Group B: Femara® 2.5 mgActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS)

PFS per Investigator assessment, defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. PFS will be assessed via a local radiology assessment according to RECIST v1.1. PFS as assessed through a blinded independent central review will be used for supportive evidence of the primary efficacy endpoint.

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).

Secondary outcomes

1

Overall Survival (OS): Primary analysis

OS, defined as the time from the date of randomization to date of death from any cause.

Time frame
From the date of randomization to date of death from any cause (up to approximately 30 months).
2

Overall Survival (OS): Final analysis

OS, defined as the time from the date of randomization to date of death from any cause.

Time frame
From the date of randomization to date of death from any cause (up to approximately 88 months).
3

Objective Response Rate (ORR)

ORR, defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) by Investigator assessment per RECIST v1.1 criteria.

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).
4

Incidence of arthralgias/arthritis and/or myalgias

To compare the incidence rate of a combined event of arthralgias/arthritis and/or myalgias between Letrozole SIE and Femara®

Time frame
From the date of the first dose of study intervention to the post-discontinuation visit (up to approximately 30 months).

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rovi Pharmaceuticals Laboratories

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: