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Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer

ConditionsBreast CancerLocally Advanced Breast CancerMetastatic Breast CancerER Positive Breast CancerHER2 Negative Breast Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOlema Pharmaceuticals, Inc.

About this trial

This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult female or male participants.

ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.

Evaluable disease (measurable disease per RECIST 1.1 or bone-only disease).

De novo advanced breast cancer or with disease recurrence occurring after 12 months of completing adjuvant endocrine therapy (with or without CDK4/6 inhibitors)

Disqualifiers

Disease recurrence during adjuvant endocrine therapy

Currently receiving or previously received systemic anti-cancer therapy for ER+, HER2- advanced breast cancer.

Previously received treatment with fulvestrant, elacestrant or an investigational endocrine therapy in any setting.

History of allergic reactions to study treatment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Palazestrant

    Drug

    Participants will be treated with palazestrant 90 mg once daily on a 4-week (28-day) cycle.

  • Letrozole-matching placebo

    Drug

    Participants will be treated with letrozole-matching placebo once daily on a 4-week (28 day) cycle

  • Ribociclib

    Drug

    Participants will be treated with ribociclib 600 mg once daily on Days 1-21 of a 4-week (28 day) cycle.

  • Letrozole

    Drug

    Participants will be treated with letrozole 2.5 mg once daily on a 4-week (28-day) cycle

  • Palazestrant matching-placebo

    Drug

    Participants will be treated with palazestrant-matching placebo once daily on a 4-week (28-day) cycle

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: PalazestrantExperimental treatment 3 interventions
Group B: LetrozoleActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS)

To compare PFS, based on a local investigator assessment, between investigational (palazestrant with ribociclib + letrozole-matching placebo) and control (letrozole with ribociclib + palazestrant-matching placebo) arms.

Time frame
From Date of Randomization until Disease Progression or Death Due to Any Cause (estimated as up to 3.5 years)

Secondary outcomes

1

Overall Survival (OS)

To compare OS between investigational and control arms.

Time frame
From Date of Randomization until Death Due to Any Cause (estimated as up to 5.5 years)
2

Progression Free Survival (PFS)

To evaluate PFS based on Blinded Independent Review Committee (BIRC) assessment

Time frame
From Date of Randomization until Disease Progression or Death Due to Any Cause (estimated as up to 3.5 years)
3

Overall response Rate (ORR)

To evaluate ORR based on Blinded Independent Review Committee (BIRC) assessment

Time frame
From Date of Randomization until Tumor Response (estimated as up to 3.5 years)
4

Duration of Response (DOR)

To evaluate DOR based on Blinded Independent Review Committee (BIRC) assessment

Time frame
From Date of Tumor Response (CR or PR) until Disease Progression (estimated as up to 3.5 years)

Other outcomes

Sponsors and contacts

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

Olema Pharmaceuticals, Inc.

Lead sponsor

Novartis Pharmaceuticals

Collaborator

Source ClinicalTrials.gov
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