Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06938724 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Omission of Local Therapies in Women Patients With HER2-positive or Triple-negative Breast Cancer

Study acronym: OLT
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Primary and study completion dates: Jun 15, 2035 to Jul 25, 2035
    • Start date changed from estimate of Jun 15, 2025 to Jul 25, 2025
    v3
  2. Start date: Apr 15, 2025 to Jun 15, 2025
    • Primary and study completion dates: Apr 15, 2035 to Jun 15, 2035
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
HER2-positive and Triple-negative are subtypes of breast cancer more sensitive to systemic therapies, where the complete pathological response rate may be higher than 50%. This gave rise to doubts about the usefulness of traditional local treatments for such responders. Omission of surgery after vacuum assisted breast biopsy (VABB) as well omission of radiotherapy after conservative surgery would now seem to be reasonable alternatives to standard care for highly selected patients, in whom systemic treatments have provided the maximum response.
Trial Details
NCT Number NCT06938724
Lead Sponsor Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Conditions
(from sponsor)		 Breast Neoplasm Malignant Female
Enrollment 152 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov