Resumen

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).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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
Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of \>= 6 months
LVEF (left ventricular ejection fraction) of at least 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
Adequate hematologic and organ function prior to initiation of study treatment

Criterios de exclusión

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
Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
Participants with active HBV infection
Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis
Symptomatic active lung disease, including pneumonitis or interstitial lung disease
Any history of leptomeningeal disease or carcinomatous meningitis
Serious infection requiring IV antibiotics within 7 days prior to Day 1 of Cycle 1
Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition
Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye

Intervenciones

drug

Inavolisib

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.

drug

Phesgo

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

drug

Placebo

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

drug

Taxane-based Chemotherapy

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

drug

Optional Endocrine Therapy of Investigator's Choice

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.

Ubicaciones

Centro de Investigaciones Médicas y Desarrollo LC S.R.L

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

ACTIVE_NOT_RECRUITING

Centro Oncologico Korben

Ciudad Autonoma Buenos Aires, Argentina

RECRUITING

Instituto de Oncología de Rosario

Rosario, Argentina

RECRUITING

Hospital Provincial del Centenario

Rosario, Argentina

RECRUITING

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

San Juan, Argentina

RECRUITING

Clínica Viedma

Viedma Rio Negro, Argentina

WITHDRAWN

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Inavolisib

Phesgo

Placebo

Taxane-based Chemotherapy

Optional Endocrine Therapy of Investigator's Choice

Ubicaciones

Centro de Investigaciones Médicas y Desarrollo LC S.R.L

Centro Oncologico Korben

Instituto de Oncología de Rosario

Hospital Provincial del Centenario

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

Clínica Viedma

Patrocinadores

Contactos

Reference Study ID Number: WO44263 https://forpatients.roche.com/