NCT03875573: Neo-CheckRay

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

Active, enrolled Phase 2 Last updated 20 December 2024

What this trial tests

Phase 2 trial testing Durvalumab in Luminal B in 147 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

6 November 2019

Primary endpoint
30 May 2025

30 September 2029

Quick facts

Lead sponsor	Jules Bordet Institute
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	147
Start date	6 November 2019
Primary completion	30 May 2025
Estimated completion	30 September 2029
Sites	7 locations across Belgium, France

Drugs / interventions tested

• Durvalumab — full drug profile →
• Stereotactic Body Radiotherapy
• Oleclumab — full drug profile →

Conditions studied

• Luminal B — all drugs for Luminal B →

Sponsor

Jules Bordet Institute

Who can join

18 and older, female only, with Luminal B. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immune checkpoint modulators in cancer immunotherapy: recent advances and emerging concepts.
   Wang Y, Zhang H, Liu C, Wang Z, et al · · 2022 · cited 179× · PMID 35978433 · DOI 10.1186/s13045-022-01325-0
2. ATP and Adenosine Metabolism in Cancer: Exploitation for Therapeutic Gain.
   Yegutkin GG, Boison D. · · 2022 · cited 111× · PMID 35738682 · DOI 10.1124/pharmrev.121.000528
3. First-in-human study of oleclumab, a potent, selective anti-CD73 monoclonal antibody, alone or in combination with durvalumab in patients with advanced solid tumors.
   Bendell J, LoRusso P, Overman M, Noonan AM, et al · · 2023 · cited 87× · PMID 37016126 · DOI 10.1007/s00262-023-03430-6
4. Landscape of Myeloid-derived Suppressor Cell in Tumor Immunotherapy.
   Hao Z, Li R, Wang Y, Li S, et al · · 2021 · cited 72× · PMID 34689842 · DOI 10.1186/s40364-021-00333-5
5. CD73's Potential as an Immunotherapy Target in Gastrointestinal Cancers.
   Harvey JB, Phan LH, Villarreal OE, Bowser JL. · · 2020 · cited 72× · PMID 32351498 · DOI 10.3389/fimmu.2020.00508
6. Inhibition of the Adenosine Pathway to Potentiate Cancer Immunotherapy: Potential for Combinatorial Approaches.
   Thompson EA, Powell JD. · · 2021 · cited 61× · PMID 32903139 · DOI 10.1146/annurev-med-060619-023155
7. Targeting purinergic pathway to enhance radiotherapy-induced immunogenic cancer cell death.
   Bao X, Xie L. · · 2022 · cited 54× · PMID 35836249 · DOI 10.1186/s13046-022-02430-1
8. Luminal Breast Cancer: Risk of Recurrence and Tumor-Associated Immune Suppression.
   Pellegrino B, Hlavata Z, Migali C, De Silva P, et al · · 2021 · cited 52× · PMID 33974235 · DOI 10.1007/s40291-021-00525-7