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Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 423 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Site contacts updated at 1 of 561 sites
  2. Study sites: 560 to 561
  3. Site details revised at 1 of 560 sites
  4. Site details revised at 2 of 560 sites
  5. Study sites: 558 to 560
Show 15 earlier versionsHide 15 earlier versions
  1. Study sites revised (558)
  2. Study sites: 557 to 558
  3. Study sites: 556 to 557
  4. Site details revised at 2 of 556 sitesv415
  5. Site details revised at 4 of 556 sitesv414
  6. Site details revised at 3 of 556 sitesv413
  7. Site details revised at 2 of 556 sitesv412
  8. Study sites: 555 to 556v411
  9. Site details revised at 5 of 555 sitesv410
  10. Site details revised at 2 of 555 sitesv409
  11. Site details revised at 1 of 555 sitesv408
  12. Study sites: 554 to 555v407
  13. Study sites: 553 to 554v406
  14. Site details revised at 2 of 553 sitesv405
  15. Site contacts updated at 4 of 553 sitesv404
  1. Trial sites expanded: 545 → 552 locationsv403
  2. Study sites: 545 to 552v402
  3. Site contacts updated at 3 of 545 sitesv401
  4. Study sites: 544 to 545v400
  5. Site details revised at 1 of 544 sitesv399
  6. Site details revised at 1 of 544 sitesv398
  7. Study sites: 545 to 544v397
  8. Study sites: 544 to 545v396
  9. Site details revised at 1 of 544 sitesv395
  10. Site details revised at 3 of 544 sitesv394
  11. Study sites: 543 to 544v393
  12. Site details revised at 1 of 543 sitesv392
  13. Study sites: 542 to 543v391
  14. Site details revised at 3 of 542 sitesv390
  15. Study sites: 541 to 542v389
  16. Re-verified, no change to tracked fieldsv388
  17. Study sites revised (541)v387 See this version in full on ClinicalTrials.gov ↗
  18. Site details revised at 1 of 541 sitesv386
  19. Study sites revised (541)v385 See this version in full on ClinicalTrials.gov ↗
  20. Site details revised at 1 of 541 sitesv384
  21. Site details revised at 1 of 541 sitesv383
  22. Study sites revised (541)v382 See this version in full on ClinicalTrials.gov ↗
  23. Study sites: 539 to 541v381
  24. Study sites: 538 to 539v380
  25. Study sites: 537 to 538v379
  26. Primary and study completion pushed from May 31, 2027 to May 31, 2032 Site details revised at 1 of 537 sitesv378 Show 1 more changeShow less
    • Site details revised at 1 of 537 sites
  27. Primary and study completion dates: May 31, 2027 to May 31, 2032 Site details revised at 1 of 537 sitesv377 Show 1 more changeShow less
    • Site details revised at 1 of 537 sites
  28. Site details revised at 2 of 537 sitesv376
  29. Study sites: 536 to 537v375
  30. Site details revised at 5 of 536 sitesv374
  • 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.
This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as paclitaxel, doxorubicin, and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. There is some evidence from previous clinical trials that people who have a MammaPrint High 2 Risk result may be more likely to respond to chemotherapy and immunotherapy. Adding durvalumab to usual chemotherapy may be able to prevent the cancer from returning for patients with MP2 stage II-III hormone receptor positive, HER2 negative breast cancer.
Trial Details
NCT Number NCT06058377
Lead Sponsor National Cancer Institute (NCI)
Conditions Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2-Negative Breast Carcinoma, Hormone Receptor-Positive Breast Carcinoma
Enrollment 3,680 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov