Health Trials

A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

ConditionMetastatic Breast 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 inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection

Confirmation of HER2 biomarker eligibility based on valid results from central testing of tumor tissue documenting HER2-positivity

Confirmation of PIK3CA-mutation biomarker eligibility based on valid results from central testing of tumor tissue documenting PIK3CA-mutated tumor status

Disqualifiers

Prior treatment in the locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway

Any prior systemic non-hormonal anti-cancer therapy for locally advanced or metastatic HER2-positive breast cancer prior to initiation of induction therapy

History or active inflammatory bowel disease

Disease progression within 6 months of receiving any HER2-targeted therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inavolisib

    Drug

    Participants will receive an inavolisib tablet to be taken orally (PO), once a day (QD), on Days 1-21 of each 21-day cycle, beginning on Day (D) 1 of Cycle (C) 1 of maintenance treatment.

  • Phesgo

    Drug

    Phesgo will be administered to participants subcutaneously every 3 weeks (Q3W) on D1 of each 21-day cycle.

  • Placebo

    Drug

    Inavolisib-matching tablet taken PO QD on Days 1-21 of each 21-day cycle, beginning on D1 C1 of maintenance treatment.

  • Taxane-based Chemotherapy

    Drug

    During the induction therapy phase, the investigator's choice of taxane-based chemotherapy will be administered after Phesgo.

  • Optional Endocrine Therapy of Investigator's Choice

    Drug

    Optional endocrine therapy (ET) is allowed at the discretion of the investigator, based on the standard of care. Allowed ETs are tamoxifen, or one of the specified third-generation aromatase inhibitor (AI \[anastrozole, letrozole, or exemestane\]), or fulvestrant. The investigator will determine and supply the appropriate luteinizing hormone-releasing hormone (LHRH) agonist locally approved for use in breast cancer. The LHRH agonist will be administered according to local prescribing information.

Treatment groups

230 Participants
are divided into 3 treatment groups
Group A: Induction Therapy: Phesgo plus Taxane-Based ChemotherapyOther 2 interventions
Group B: Maintenance Therapy: Inavolisib plus PhesgoExperimental treatment 3 interventions
Group C: Maintenance Therapy: Placebo plus PhesgoActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Investigator-Assessed Progression-Free Survival (PFS)

Time frame
Up to approximately 40 months

Secondary outcomes

1

Overall Survival (OS)

Time frame
Up to approximately 111 months
2

Investigator-Assessed Objective Response Rate (ORR)

Time frame
Up to approximately 111 months
3

Investigator-Assessed Duration of Response (DOR)

Time frame
Up to approximately 111 months
4

Investigator-Assessed Clinical Benefit Rate (CBR)

Time frame
Up to approximately 111 months

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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