ABemaciclib, ET ± paclItaxel in aGgressive HR+/HER2- MBC trIaL
- Conditions
- Breast Cancer Metastatic
- Interventions
- Registration Number
- NCT04603183
- Lead Sponsor
- MedSIR
- Brief Summary
This is a multicenter, randomized, 2 arm, open label, phase II study. It is designed to compare the efficacy and safety of abemaciclib combined with ET (letrozole or fulvestrant) versus a short course with induction chemotherapy with paclitaxel followed by maintenance therapy with abemaciclib combined with ET (letrozole or fulvestrant) in patients with previously untreated, unresectable locally advanced, or metastatic HR positive/HER2 negative breast cancer with aggressive disease criteria.
- Detailed Description
The ABIGAIL study aims to provide consistent evidence that the combination of abemaciclib with ET -consisting of letrozole or fulvestrant-as first-line regimen is non-inferior to the optimal first-line chemotherapy -consisting of weekly paclitaxel-in terms of early ORR after the first 12 weeks of treatment in patients with HR-positive/HER2-negative ABC and at least one feature of aggressive disease associated with poor prognosis.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 162
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Arm (Arm B) Paclitaxel Paclitaxel 90 mg/m² infused over 1 hour on Days 1, 8, and 15 of the 28 day cycle, with at least a 6-day time span between separated doses. Interventional Arm (Arm A) Abemaciclib Abemaciclib 150 mg orally twice daily (BID) during each 28 day cycle combined with ET (2.5 mg letrozole, orally administered and taken daily during each 28-day cycle, or 500 mg fulvestrant, by intramuscular \[IM\] administration on Days 1 and 15 (±3 days) of the first treatment cycle and Day 1 of each cycle thereafter. Interventional Arm (Arm A) Letrozole Abemaciclib 150 mg orally twice daily (BID) during each 28 day cycle combined with ET (2.5 mg letrozole, orally administered and taken daily during each 28-day cycle, or 500 mg fulvestrant, by intramuscular \[IM\] administration on Days 1 and 15 (±3 days) of the first treatment cycle and Day 1 of each cycle thereafter. Interventional Arm (Arm A) Fulvestrant Abemaciclib 150 mg orally twice daily (BID) during each 28 day cycle combined with ET (2.5 mg letrozole, orally administered and taken daily during each 28-day cycle, or 500 mg fulvestrant, by intramuscular \[IM\] administration on Days 1 and 15 (±3 days) of the first treatment cycle and Day 1 of each cycle thereafter.
- Primary Outcome Measures
Name Time Method 12-week overall response rate (ORR) 12 weeks Complete response (CR) or partial response (PR), during the first 12 weeks of treatment as per blinded independent central review, using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1.
- Secondary Outcome Measures
Name Time Method ORR Baseline up to 24 months The best overall response of CR or PR, as per investigator assessment and per blinded independent central review, using RECIST v 1.1.
Clinical benefit rate (CBR) Baseline up to 24 months An objective response (CR or PR), or stable disease for at least 24 weeks, as per investigator assessment and blinded independent central review using RECIST v 1.1.
12-week progression-free survival (PFS) rate Baseline up to 12 weeks The proportion of patients with disease progression or death from any cause, whichever occurs first during the first 12 weeks from randomization, as per investigator assessment and blinded independent central review using RECIST v 1.1.
PFS Baseline up to 24 months The period of time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first, as per investigator assessment and blinded independent central review using RECIST v 1.1.
Time to response (TTR) Baseline up to 24 months The time from randomization to time of the first objective tumor response (tumor shrinkage of ≥30%) observed in patients who achieved a CR or PR, as per investigator assessment and blinded independent central review using RECIST v 1.1.
Duration of response (DoR) Baseline up to 24 months The time from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, as per investigator assessment and per blinded independent central review using RECIST v 1.1.
Overall survival (OS) Baseline up to 24 months The time from randomization to death from any cause, as per investigator assessment and blinded independent central review using RECIST v 1.1.
Maximum tumor shrinkage (MTS) Baseline up to 24 months The biggest decrease, or smallest increase if no decrease will be observed, as per investigator assessment and blinded independent central review using RECIST v 1.1.
Time to first subsequent therapy (TFST) Baseline up to 24 months The time from randomization to the time a patient starts his/her first line treatment (first subsequent therapy).
Patient-reported global quality of life (QoL) At the beginning of each cycle up to 36 months after study start. Overall change from baseline in patient-reported global QoL, general health status, functioning and symptoms; time to deterioration in global QoL; and time to deterioration in pain.
Time to second subsequent therapy (TSST) Baseline up to 24 months The time from randomization to the time a patient starts his/her second line treatment (second subsequent therapy).
Time to first chemotherapy (TFC) Baseline up to 24 months The time from randomization to the time a patient included in Arm A starts his/her first line chemotherapy.
Incidence of adverse events (AEs) Baseline up to 24 months Number of patients with treatment-related AEs (Grade 3 and 4 AEs and serious adverse events \[SAEs\]) by using the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v.5.0.
Trial Locations
- Locations (31)
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Instituto Europeo di Oncologia
🇮🇹Milano, Italy
Azienda Ospedaliero-Universitaria Cittá de la Salute e della Scienza
🇮🇹Torino, Italy
Hospital Fernando da Fonseca
🇵🇹Amadora, Portugal
Fundación Althaia Manresa
🇪🇸Manresa, Barcelona, Spain
Hospital Universitari de Sant Joan de Reus
🇪🇸Reus, Tarragona, Spain
Centro Oncoloxico de Galicia
🇪🇸A Coruña, Coruña, Spain
Hospital de Santa Maria - Centro Hospitalar Lisboa Norte
🇵🇹Lisboa, Portugal
Hospital Universitario Reina Sofia
🇪🇸Córdoba, Cordoba, Spain
Complejo Asistencial Universitario De León
🇪🇸León, Leon, Spain
Ospedale San Gerardo
🇮🇹Monza, Italy
Ospedale Guglielmo da Saliceto
🇮🇹Piacenza, Italy
Hospital Universitario San Cecilio
🇪🇸Granada, Spain
Hospital Universitario Clinico San Carlos
🇪🇸Madrid, Spain
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Pamplona/Iruña, Spain
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital Quiron Salud Dexeus
🇪🇸Barcelona, Spain
Hospital Universitario Arnau de Vilanova
🇪🇸Lleida, Spain
Institut Catala D'Oncologia Girona - Hospital Josep Trueta
🇪🇸Girona, Spain
Consorcio Hospitalario Provincial de Castellon
🇪🇸Castellón De La Plana, Spain
Hospital Beata María Ana
🇪🇸Madrid, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Ruber Juan Bravo
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Quirónsalud Sagrado Corazón
🇪🇸Sevilla, Spain
Hospital Quironsalud Valencia
🇪🇸Valencia, Spain
Hospital Arnau de Vilanova
🇪🇸Valencia, Spain
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Hospital Universitario Basurto
🇪🇸Bilbao, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Andalucía, Spain
Consorcio Hospital General Universitario de Valencia
🇪🇸Valencia, Spain