MedTrace Logo

Adjuvant Treatment for High-risk Triple Negative Breast Cancer Patients With the Anti-PD-l1 Antibody Avelumab

NCT02926196 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 474

Last updated 2025-12-12

No results posted yet for this study

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.

Conditions

  • Triple Negative Breast Neoplasms

Interventions

DRUG

MSB0010718C

MSB0010718C-Avelumab is formulated as vials of 200 mg strength for IV administration

Sponsors & Collaborators

  • University of Padova

    collaborator OTHER

  • Dipartimento di scienze chirurgiche, Oncologiche e Gastroenterologiche

    collaborator UNKNOWN

  • Istituto Oncologico Veneto IRCCS

    lead OTHER

Principal Investigators

  • Valentina Guarneri, Prof · University of Padua and Istituto Oncologico Veneto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-17
Primary Completion
2024-06-30
Completion
2025-10-09

Countries

  • Italy
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02926196 on ClinicalTrials.gov