Estudio de fase III, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y seguridad de inavolisib más palbociclib y fulvestrant frente a placebo más palbociclib y fulvestrant en pacientes con cáncer de mama localmente avanzado o metastásico, con mutación de PIK3CA, receptor hormonal positivo y HER2 negativo

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT04191499Tipo: INTERVENTIONALInicio: 29 de ene de 2020Fin estimado: 15 de nov de 2027

Resumen

Este estudio evaluará la eficacia, seguridad y farmacocinética de inavolisib en combinación con palbociclib y fulvestrant en comparación con placebo más palbociclib y fulvestrant en participantes con cáncer de mama localmente avanzado o metastásico con mutación de PIK3CA, receptor hormonal (RH) positivo y HER2 negativo, cuya enfermedad progresó durante el tratamiento o dentro de los 12 meses posteriores a la finalización de la terapia endocrina adyuvante, y que no han recibido terapia sistémica previa para la enfermedad metastásica.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Confirmed diagnosis of HR+/HER2- breast cancer
Metastatic or locally advanced disease not amenable to curative therapy
Progression of disease during adjuvant endocrine treatment or within 12 months of completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen
Receiving LHRH agonist therapy for at least 2 weeks prior to Day 1 of Cycle 1 if pre/peri-menopausal
Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)
Consent to provide fresh or archival tumor tissue specimen
Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1); evaluable "bone-only" disease is not eligible; "bone-only" disease with at least one measurable, soft-tissue component, even if considered disease that is limited to bone but has lytic or mixed lytic/blastic lesions and at least one measurable soft-tissue component per RECIST v1.1 may be eligible
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Life expectancy of \> 6 months
Adequate hematologic and organ function within 14 days prior to initiation of study treatment

Criterios de exclusión

Metaplastic breast cancer
Any history of leptomeningeal disease or carcinomatous meningitis
Any prior systemic therapy for metastatic breast cancer
Prior treatment with fulvestrant or any selective estrogen-receptor degrader, with the exception of participants that have received fulvestrant or any selective estrogen-receptor degrader as part of neoadjuvant therapy only and with treatment duration of no longer than 6 months
Prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway
Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
Known and untreated, or active CNS metastases. Patients with a history of treated CNS metastases may be eligible
Active inflammatory or infectious conditions in either eye, or any eye conditions expected to require surgery during the study treatment period
Symptomatic active lung disease, or requiring daily supplemental oxygen
History of inflammatory bowel disease or active bowel inflammation
Anti-cancer therapy within 2 weeks before study entry
Investigational drug(s) within 4 weeks before randomization
Prior radiotherapy to \>= 25% of bone marrow, or hematopoietic stem cell or bone marrow transplantation
Chronic corticosteroid therapy or immunosuppressants
Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or within 2 weeks after the final dose of study treatment
Major surgical procedure, or significant traumatic injury, within 28 days prior to Day 1 of Cycle 1

Intervenciones

drug

Inavolisib

Participants will receive oral inavolisib on Days 1-28 of each 28-day cycle.

drug

Placebo

Participants will receive oral placebo on Days 1-28 of each 28-day cycle.

drug

Palbociclib

Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.

drug

Fulvestrant

Participants will receive intramuscular (IM) fulvestrant approximately every 4 weeks.

Ubicaciones

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

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Centro Oncologico Korben

Ciudad Autonoma Buenos Aires, Argentina

Hosp Provincial D. Centenarios

Rosario, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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