Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06225505 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Early Detection of Triple Negative Breast Cancer Relapse (CUPCAKE)

Study acronym: CUPCAKE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria revised
    • Study sites revised (13)
    v8
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 26, 2026 to Jan 5, 2026
    • Site details revised at 13 of 13 sites
    v7
  3. Primary completion date: Dec 15, 2026 to Aug 3, 2031v6 Show 7 more changesShow less
    • Start date: Jun 30, 2024 to Jan 26, 2026
    • Study completion date: Dec 15, 2028 to Aug 3, 2031
    • Eligibility criteria revised
    • Secondary endpoints: 7 to 8
    • Study description expanded, about 17 words
    • Collaborators: 2 to 4
    • Study title expanded, about 1 word
  4. Start date: Jun 1, 2024 to Jun 30, 2024v5
  5. Re-verified, no change to tracked fieldsv4
Show 2 earlier versionsHide 2 earlier versions
  1. Phase: Phase 2 to Not applicablev3 Show 4 more changesShow less
    • Start date: Mar 1, 2024 to Jun 1, 2024
    • Study sites: 12 to 13
    • Primary completion date: Sep 15, 2026 to Dec 15, 2026
    • Study completion date: Sep 15, 2028 to Dec 15, 2028
  2. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
CUPCAKE is a randomized, non-comparative, multicenter, proof-of-concept phase II trial, using the Trials within Cohorts concept(1) to assess the clinical utility of ctDNA monitoring combined with 68Ga-FAPI-46-PET-CT imaging upon ctDNA detection for the surveillance of patients with a non-metastatic TNBC at high risk of relapse. The study has two steps. In Step 1, patients who have completed the treatments for a localized TNBC will undergo ctDNA monitoring every \~4 months (± 2 weeks). In Step 2, patients for whom ctDNA will be detected will then be randomized between an observation arm, in which monitoring will continue until the detection of a clinical relapse, and an experimental arm, in which the ctDNA detection will be revealed to both the patient and the clinician: patients will then undergo a 18F-FDG PET-CT and a 68Ga-FAPI-46-PET-CT, in addition to whatever workup the investigator will deem necessary.
Trial Details
NCT Number NCT06225505
Lead Sponsor Institut Curie
Collaborators: National Research Agency, France, Roche Pharma AG, Personalis Inc., UNICANCER
Conditions
(from sponsor)		 Triple Negative Breast Cancer
Related terms Triple Negative Breast Neoplasms
Enrollment 450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov