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

Study acronym: Neo-CheckRay
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of May 30, 2025 to Nov 30, 2024 Eligibility criteria expanded, about 58 words · Secondary endpoints: details revised at 4 of 9 entries · Study description expanded, about 7 words · 1 more Show 4 more changesShow less
    • Eligibility criteria expanded, about 58 words
    • Secondary endpoints: details revised at 4 of 9 entries
    • Study description expanded, about 7 words
    • Publications: details revised at 3 of 3 entries
  2. Primary completion date: Sep 30, 2024 to May 30, 2025v16
  3. Secondary endpoints: 6 to 9 Study description shortened, about 17 wordsv15 Show 1 more changeShow less
    • Study description shortened, about 17 words

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: Jan 31, 2024 to Sep 30, 2024 Trial status: Recruiting to Active, Not Recruiting · Completion date: Jan 15, 2026 to Sep 30, 2029 · Site details revised at 7 of 7 sitesv14 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Jan 15, 2026 to Sep 30, 2029
    • Site details revised at 7 of 7 sites
  5. Primary completion date: Dec 31, 2023 to Jan 31, 2024v13
Show 11 earlier versionsHide 11 earlier versions
  1. Study sites: 6 to 7v12
  2. Eligibility criteria expanded, about 48 wordsv11 See this version in full on ClinicalTrials.gov ↗
  3. Primary completion date: Oct 15, 2022 to Dec 31, 2023 Completion date: Oct 15, 2025 to Jan 15, 2026v10 Show 1 more changeShow less
    • Completion date: Oct 15, 2025 to Jan 15, 2026
  4. Site details revised at 1 of 6 sitesv9
  5. Site details revised at 1 of 6 sitesv8
  6. Trial status: Active, Not Recruiting to Recruiting Start date: Sep 20, 2019 to Nov 6, 2019 · Site details revised at 6 of 6 sitesv7 Show 2 more changesShow less
    • Start date: Sep 20, 2019 to Nov 6, 2019
    • Site details revised at 6 of 6 sites
  7. Secondary endpoints: details revised at 1 of 6 entriesv6
  8. Primary endpoints revised (3) Study sites: 1 to 6 · Eligibility criteria expanded, about 322 words · Secondary endpoints revised (6) · 1 morev5 Show 4 more changesShow less
    • Study sites: 1 to 6
    • Eligibility criteria expanded, about 322 words
    • Secondary endpoints revised (6)
    • Study description expanded, about 28 words

    See this version in full on ClinicalTrials.gov ↗

  9. Trial status: Recruiting to Active, Not Recruiting Primary completion date: Jun 15, 2022 to Oct 15, 2022 · Completion date: Jun 15, 2025 to Oct 15, 2025 · Site details revisedv4 Show 3 more changesShow less
    • Primary completion date: Jun 15, 2022 to Oct 15, 2022
    • Completion date: Jun 15, 2025 to Oct 15, 2025
    • Site details revised
  10. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 1, 2019 to Sep 20, 2019 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Sep 1, 2019 to Sep 20, 2019
    • Site details revised
  11. Start date: Jun 15, 2019 to Sep 1, 2019v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03875573
Lead Sponsor Jules Bordet Institute
Collaborators: Institut Curie, AstraZeneca
Conditions Luminal B
Enrollment 147 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov