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A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHoffmann-La Roche

About this trial

This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women or men with histologically or cytologically confirmed carcinoma of the breast

Documented ER-positive and/or progesterone receptor-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines

Documented HER2-negative tumor according to ASCO/CAP guidelines

De-novo HR+ , HER2- ABC, or, alternatively, relapsed HR+ , HER2- ABC after at least 2 years of standard neoadjuvant/adjuvant endocrine therapy without disease progression during that treatment and disease-free interval of at least 1 year since the completion of that treatment

Disqualifiers

Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required

Metaplastic breast cancer

Any prior systemic therapy for locally advanced unresectable or metastatic breast cancer

Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inavolisib

    Drug

    Participants will receive oral inavolisib once daily (QD).

  • Placebo

    Drug

    Participants will receive oral placebo QD.

  • CDK4/6i

    Drug

    Participants will receive CDK4/6i on either Days 1-21 or Days 1-28 of each 28-day cycle.

  • Letrozole

    Drug

    Participants will receive oral letrozole QD.

Treatment groups

450 Participants
are divided into 2 treatment groups
Group A: Inavolisib + Letrozole + CDK4/6iExperimental treatment 3 interventions
Group B: Placebo + Letrozole + CDK4/6iPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS)

Time frame
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years)

Secondary outcomes

1

Overall Survival (OS)

Time frame
From randomization to death from any cause (up to 7 years)
2

Investigator-assessed Objective Response Rate (ORR)

Time frame
Up to 7 years
3

Investigator-assessed Duration of Response (DOR)

Time frame
From the first occurrence of a confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years)
4

Investigator-assessed Clinical Benefit Rate (CBR)

Time frame
Up to 7 years

Other outcomes

Sponsors and contacts

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

Hoffmann-La Roche

Lead sponsor

Source ClinicalTrials.gov
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