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

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Hoffmann-La Roche
Study ID
NCT05894239
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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).

Key Dates

Start date
Sep 8, 2023
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 28, 2032

Study Design

Enrollment
230 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Induction Therapy: Phesgo plus Taxane-Based Chemotherapy
    Participants will be administered the treatments as outlined in the interventions section.
  • Experimental: Maintenance Therapy: Inavolisib plus Phesgo
    Participants will be administered the treatments as outlined in the interventions section.
  • Active Comparator: Maintenance Therapy: Placebo plus Phesgo
    Participants will be administered the treatments as outlined in the interventions section.

Primary Outcome Measure

Investigator-Assessed Progression-Free Survival (PFS) [ Time Frame: Up to approximately 40 months ]

Central Contacts

  • Reference Study ID Number: WO44263 https://forpatients.roche.com/
    888-662-6728 (U.S. Only)
    [email protected]
  • Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (20)

FacilityCityStateZIPSite coordinators
Banner Health MD Anderson AZGilbertArizona85234-
Disney Family Cancer CenterBurbankCalifornia91505-
City of HopeCoronaCalifornia92882-
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
City of Hope at Irvine LennarIrvineCalifornia92618-
Ellison Institute of TechnologyLos AngelesCalifornia90064-
Georgetown Uni HospitalWashington D.C.District of Columbia20007-
Medstar Research InstituteHyattsvilleMaryland20783-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Henry Ford HospitalDetroitMichigan48202-
Renown Regional Medical CenterRenoNevada89502-
Hackensack University Medical CenterHackensackNew Jersey07601-
Atrium HealthCharlotteNorth Carolina28209-
Hightower ClinicalOklahoma CityOklahoma73102-
Renovatio Clinical - El PasoEl PasoTexas79915-
JPS Health NetworkFort WorthTexas76104-
Lumi ResearchKingwoodTexas77339-
Renovatio ClinicalThe WoodlandsTexas77380-
Kadlec Clinic Hematology and OncologyKennewickWashington99336-7774-
Swedish Medical CenterSeattleWashington98104-1360-

Find similar trials in Gilbert, AZ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Banner Health MD Anderson AZ· Gilbert, AZDisney Family Cancer Center· Burbank, CACity of Hope· Corona, CACity of Hope Comprehensive Cancer Center· Duarte, CACity of Hope at Irvine Lennar· Irvine, CAEllison Institute of Technology· Los Angeles, CA

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