Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT02957968 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Neoadjuvant Pembrolizumab + Decitabine Followed by Std Neoadj Chemo for Locally Advanced HER2- Breast Ca

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv38
  2. Study completion date: Mar 31, 2026 to Mar 31, 2027v37
  3. Study sites: 5 to 4
    • Study completion date: Feb 28, 2025 to Mar 31, 2026
    • Secondary endpoints: 11 to 12
    • Publications: details revised at 1 of 1 entry
    v36
  4. Re-verified, no change to tracked fieldsv35
  5. Results first posted: Nov 9, 2023
    • Secondary endpoints revised (11)
    v34
Show 32 earlier versionsHide 32 earlier versions
  1. Secondary endpoints revised (11)v33
  2. Primary endpoint revised
    • Secondary endpoints revised (11)
    v32
  3. Primary endpoint revisedv31 Show 4 more changesShow less
    • Enrollment target: 47 to 46
    • Primary completion date changed from estimate of Feb 28, 2025 to Aug 4, 2022
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: 10 to 11
  4. Primary endpoint revised
    • Secondary endpoints revised (10)
    v30
  5. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 50 to confirmed 47
    • Study sites: 6 to 5
    v29
  6. Enrollment target: 32 to 50v28 Show 5 more changesShow less
    • Primary completion date: Feb 28, 2022 to Feb 28, 2025
    • Study completion date: Feb 28, 2023 to Feb 28, 2025
    • Study description shortened, about 20 words
    • Site contacts updated at 2 of 6 sites
    • Study arms: 2 to 3
  7. Study sites: 5 to 6v27
  8. Secondary endpoints: 9 to 10
    • Eligibility criteria expanded, about 1 word
    v26
  9. Site details revised at 1 of 5 sitesv25
  10. Site details revised at 1 of 5 sitesv24
  11. Site details revised at 2 of 5 sitesv23
  12. Re-verified, no change to tracked fieldsv22
  13. Site details revised at 3 of 5 sitesv21
  14. Site details revised at 1 of 5 sitesv20
  15. Eligibility criteria expanded, about 2 wordsv19
  16. Site details revised at 1 of 5 sitesv18
  17. Enrollment target: 50 to 32
    • Study sites: 1 to 5
    v17
  18. Primary endpoint revised
    • Eligibility criteria expanded, about 68 words
    • Secondary endpoints: details revised at 1 of 9 entries
    • Site contact updated
    v16
  19. Site contact updatedv15
  20. Primary completion date: Dec 31, 2028 to Feb 28, 2022
    • Study completion date: Jan 31, 2029 to Feb 28, 2023
    v14
  21. Site contact updatedv13
  22. Study completion date: Dec 31, 2028 to Jan 31, 2029v12
  23. Primary and study completion dates: Dec 31, 2018 to Dec 31, 2028v11 Show 5 more changesShow less
    • Primary endpoints: 2 to 1
    • Eligibility criteria shortened, about 40 words
    • Secondary endpoints: 8 to 9
    • Site contact updated
    • Study title revised
  24. Interventions: Carboplatin (Drug), Cyclophosphamide (Drug), Doxorubicin (Drug), Paclitaxel (Drug) to Carboplatin (Drug), Cyclophosphamide (Drug), Decitabine (Drug), Doxorubicin (Drug), Paclitaxel (Drug), Pembrolizumab (Drug)v10
  25. Re-verified, no change to tracked fieldsv9
  26. Eligibility criteria expanded, about 6 wordsv8
  27. Eligibility criteria expanded, about 39 wordsv7
  28. 2 versions Re-verified since Apr 27, 2017, no change to tracked fieldsv5-v6
  29. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Dec 2018 to Dec 31, 2018
    • Start date: Dec 2016 to Jan 24, 2017
    • Site details revised
    v4
  30. Re-verified, no change to tracked fieldsv3
  31. Collaborators: 3 to 2v2
  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.
This study is a 2-cohort, open-label, multicenter, phase 2 study of a short course of immunotherapy consisting of sequential decitabine followed by pembrolizumab administered prior to a standard neoadjuvant chemotherapy regimen for patients with locally advanced HER2-negative breast cancer. The primary efficacy objective is to determine if the immunotherapy increases the presence and percentage of tumor and/or stromal area of infiltrating lymphocytes prior to initiation of standard neoadjuvant chemotherapy. At enrollment, patients will be assigned to one of 2 cohorts based on hormone receptor status. * Cohort A - patients with HER2-negative, hormone receptor-negative breast cancer (defined as both ER and PgR with \< 10% positive staining on IHC) Note: before beginning standard neoadjuvant chemotherapy, patients in Cohort A may be reassigned to Cohort A2 to receive extended pembrolizumab as part of new standard neoadjuvant and postoperative adjuvant therapy. * Cohort B - patients with HER2-negative, hormone receptor-positive breast cancer (defined as either ER or PgR with ≥ 10% positive staining on IHC)
Trial Details
NCT Number NCT02957968
Lead Sponsor Virginia Commonwealth University
Collaborators: Merck Sharp & Dohme LLC, National Cancer Institute (NCI)
Conditions
(from sponsor)		 Breast Adenocarcinoma, Estrogen Receptor- Negative Breast Cancer, Estrogen Receptor-positive Breast Cancer, HER2/Neu Negative, Invasive Breast Carcinoma, Progesterone Receptor Negative, Progesterone Receptor Positive Tumor, Stage II Breast Cancer +5 more
Related terms Breast Neoplasms, Triple Negative Breast Neoplasms
Enrollment 46 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov