Personalizing the Use of Pembrolizumab for Patients Who Have a Strong Response in Early Triple Negative Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUNICANCER
About this trial
OPT-PEMBRO trial is a pragmatic, multicentre, international, prospective, non-inferiority, two-arms, randomised (1:1), open-label, Phase III clinical study.
The main goal of this research is to determine if patients with triple-negative breast cancer, who experience a complete response after neoadjuvant treatment, have the same chance of avoiding cancer recurrence whether they stop pembrolizumab or continue taking it for an additional 6 months.
This research will also take into account patients tolerance to treatment and quality of life.
Eligibility criteria
Qualifiers
Patient must have signed a written informed consent prior to any trial-related procedures. When the patient is physically unable to give his written consent, a trusted person of his choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent;
Age ≥ 18 years;
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
Histologically documented stage II-III breast cancer according to the primary tumour-regional lymph node anatomic staging criteria of the American Joint Committee on Cancer (AJCC), 8th edition as determined by the investigator during radiologic assessment, clinical assessment or both;
Disqualifiers
Radiological or clinical evidence of metastatic disease (stage IV) documented by imaging or clinical examination;
Evidence of recurrent disease following preoperative therapy and surgery;
Any prior history of (ipsi- or contralateral) invasive breast cancer;
Patients with a prior or concurrent malignancy (other than invasive breast cancer) whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of the investigational regimen;
Trial design
Treatments tested in this trial
- Pembrolizumab
- Deescalation
Treatment groups
2,454 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov