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Neo-adjuvant Chemotherapy Combined With Stereotactic Body Radiotherapy to the Primary Tumour +/- Durvalumab, +/- Oleclumab in Luminal B Breast Cancer:

NCT03875573 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2024-12-20

No results posted yet for this study

Summary

Neo-CheckRay is a multicenter, open-label phase II study that randomizes luminal B breast cancer subjects candidate for neo-adjuvant chemotherapy in a 1:1:1 ratio in 3 arms:

1. the combination of weekly paclitaxel followed by dose-dense doxorubicin-cyclophosphamide (ddAC) and pre-operative radiation therapy (boost dose) on the primary tumour
2. arm 1 with the addition of the anti-PD-L1 antibody durvalumab
3. arm 2 with the addition of the anti-CD73 antibody oleclumab The primary tumour will be excised 2-6 weeks after completion of ddAC. A safety run-in is planned for the 6 first subjects before starting the randomized phase II trial. Those 6 subjects will receive the treatment given in Arm 3.

Conditions

  • Luminal B

Interventions

DRUG

Durvalumab

an anti PD-L1 intravenous administration at 1500 mg every 4 weeks for 19 weeks.

RADIATION

Stereotactic Body Radiotherapy

Pre-operative radiation therapy (boost dose) 3x8 Gy on the primary tumour at week 5 given in 3 fractions. The 3 fractions will be spread at the minimum over 3 days and at the maximum over 6 days.

DRUG

Oleclumab

an anti-CD73 intravenous administration at 3000 mg every 2 weeks for the first 4 administrations then every 4 weeks for the last 3 administrations.

Sponsors & Collaborators

  • Institut Curie

    collaborator OTHER

  • AstraZeneca

    collaborator INDUSTRY

  • Jules Bordet Institute

    lead OTHER

Principal Investigators

  • Alex De Caluwe, MD · Jules Bordet Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-06
Primary Completion
2025-05-30
Completion
2029-09-30

Countries

  • Belgium
  • France

Study Locations

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Entities

Drugs
Companies

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 NCT03875573 on ClinicalTrials.gov