Adjuvant Treatment for High-risk Triple Negative Breast Cancer Patients With the Anti-PD-l1 Antibody Avelumab
- Conditions
- Triple Negative Breast Neoplasms
- Interventions
- Registration Number
- NCT02926196
- Lead Sponsor
- Istituto Oncologico Veneto IRCCS
- Brief Summary
Phase III randomized trial of the anti-PD-L1 antibody avelumab as adjuvant or post-neoadjuvant treatment for high-risk triple negative breast cancer patients. The overall protocol-defined patient population will include the following two strata of patients:
* Stratum A - Patients who have completed treatment with curative intent including surgery of the primary tumor followed by adjuvant chemotherapy .
* Stratum B - Patients who have completed treatment with curative intent including neoadjuvant chemotherapy followed by surgery of the primary tumor and (if indicated) further adjuvant chemotherapy.
- Detailed Description
* to determine whether 1 year of adjuvant Avelumab improves disease-free survival (DFS) compared to observation in patients with high-risk primary triple negative breast cancer who have completed treatment with curative intent including surgery of the primary tumor and neo- or adjuvant chemotherapy (Stratum A \[surgery of the primary tumor followed by adjuvant chemotherapy\] and Stratum B \[neoadjuvant chemotherapy followed by surgery\] combined).
* to determine whether 1 year of adjuvant Avelumab improves disease-free survival (DFS) compared to observation in patients with high-risk primary triple negative breast cancer who have completed treatment with curative intent including neoadjuvant chemotherapy followed by surgery (Stratum B).
* to determine whether Avelumab improves overall survival (OS) compared to observation in patients with high-risk primary triple negative breast cancer who have completed treatment with curative intent including surgery of the primary tumor and neo- or adjuvant chemotherapy.
* to determine whether 1 year of adjuvant Avelumab improves disease-free survival (DFS) compared to observation in PD-L1-positive (as determined by a companion diagnostic test under development) patients with high-risk primary triple negative breast cancer who have completed treatment with curative intent including surgery of the primary tumor and neo- or adjuvant chemotherapy.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 474
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm Avelumab MSB0010718C Avelumab 10 mg/kg I.V. q2w for 1 year (52 weeks)
- Primary Outcome Measures
Name Time Method Disease free survival Up to 5 years after randomization DFS is defined as the time from randomization to locoregional invasive recurrence, second primary invasive breast cancer, other second primary cancer (excluding in-situ cancers), distant metastasis or death from any cause.
Disease free survival in PD-L1-positive patients Up to 5 years after randomization DFS is defined as the time from randomization to locoregional invasive recurrence, second primary invasive breast cancer, other second primary cancer (excluding in-situ cancers), distant metastasis or death from any cause.
- Secondary Outcome Measures
Name Time Method Overall survival Up to 5 years after randomization Overall survival is defined as the time from randomization to death from any cause
Safety profile From Baseline up to 5 years after randomization Toxicity will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI -CTCAE), version 4.
Trial Locations
- Locations (70)
Ospedale di Bergamo
🇮🇹Bergamo, BG, Italy
Policlinico Sant'Orsola Malpighi
🇮🇹Bologna, BO, Italy
Ospedale di Bellaria
🇮🇹Bologna, BO, Italy
Azienda Sanitaria Locale Brindisi
🇮🇹Brindisi, BR, Italy
Azienda Spedali Civili di Brescia
🇮🇹Brescia, BS, Italy
A.S.O. S.Croce e Carle di Cuneo
🇮🇹Cuneo, CN, Italy
AOU Policlinico "Vittorio. Emanuele
🇮🇹Catania, CT, Italy
ARNAS Garibaldi,
🇮🇹Catania, CT, Italy
Arcispedale S. Anna
🇮🇹Cona, FE, Italy
AOU San Martino IST Istituto Nazionale per la Ricerca sul Cancro IRCCS
🇮🇹Genova, GE, Italy
Scroll for more (60 remaining)Ospedale di Bergamo🇮🇹Bergamo, BG, Italy