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PAveMenT: Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer

Study acronym: PAveMenT
StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jul 31, 2026 → Jul 31, 2027
See other at-risk trials from Royal Marsden NHS Foundation Trust

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing
    • Site details revised at 9 of 9 sites
    v17
  2. Primary and study completion pushed from Jul 31, 2026 to Jul 31, 2027v16
  3. Site details revised at 1 of 9 sitesv15
  4. Site contacts updated at 2 of 9 sitesv14
  5. Primary completion date: Jul 31, 2025 to Jul 31, 2026
    • Study sites: 8 to 9
    • Study completion date: Dec 31, 2025 to Jul 31, 2026
    • Eligibility criteria expanded, about 53 words
    v13
Show 11 earlier versionsHide 11 earlier versions
  1. Study sites: 7 to 8v12
  2. Study sites: 8 to 7
    • Eligibility criteria expanded, about 48 words
    v11
  3. Site contacts updated at 2 of 8 sitesv10
  4. Primary completion date: Jan 1, 2024 to Jul 31, 2025
    • Study sites: 7 to 8
    • Study completion date: Jul 1, 2024 to Dec 31, 2025
    v9
  5. Study sites: 1 to 7
    • Secondary endpoints: 3 to 4
    • Eligibility criteria expanded, about 5 words
    v8
  6. Site contact updatedv7
  7. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 10, 2020 to Aug 11, 2020
    • Site details revised
    v6
  8. Start date: Jul 1, 2020 to Aug 10, 2020v5
  9. Study title shortened, about 4 wordsv4
  10. Study title expanded, about 12 wordsv3
  11. Secondary endpoints revised (3)v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 clinical study is aiming to determine the safest doses and schedule for the combination of two drugs named palbociclib and avelumab. The study will also be investigating how effective the combination is for a subgroup of breast cancer patients whose cancer expresses the androgen receptor (AR) but not the oestrogen (hormone) or HER2 receptors. Palbociclib is a drug used in routine care for hormone-receptor (HR) positive and HER2 negative advanced breast cancer, the most common subtype of breast cancer. It is possible that the combination of palbociclib and avelumab will be a more effective cancer treatment than each drug separately, but this is unknown and this study is needed to establish the best dosage and schedule of each drug as well as how effective the combination is.
Trial Details
NCT Number NCT04360941
Lead Sponsor Royal Marsden NHS Foundation Trust
Collaborators: Pfizer, Breast Cancer Now
Conditions
(from sponsor)		 Triple Negative Breast Cancer, Locally Advanced Breast Cancer, Recurrent Breast Cancer, Metastatic Breast Cancer, ER+ Breast Cancer, HER2-positive Breast Cancer
Related terms Breast Neoplasms, Triple Negative Breast Neoplasms
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov