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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Pembrolizumab
DrugAdministration of pembrolizumab for 6 months
Deescalation
Other interventionPatients will be followed up according to standard practice for 4 years
Treatment groups
2,454 Participants
are divided into 2 treatment groupsGroup A: ControlOther 1 intervention
Group B: DeescalationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recurrence-free survival
Recurrence-free survival is defined as the time from randomisation to invasive loco-regional or distant recurrence or death from any cause, whichever occurs first.
Time frame
From randomization to disease progression or death, up to 8 years.Secondary outcomes
1
Acute and late toxicity during the study
The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders
Time frame
Throughout study, up to 1 year.2
Patient reported outcome (PRO)-CTCAE composite score
The PRO-CTCAE composite score is a self-reported questionnaire to assess selected adverse events (bloating, diarrhea, abdominal pain, rash, itching, anorexia, nausea, fatigue, dyspnea, radiation skin reaction, myalgia, arthralgia, pain, and peripheral sensory neuropathy)
Time frame
At baseline, 12 weeks, end of treatment, 1 year after end of treatment, 2 years after end of treatment and 3 years after end of treatment3
Quality of life questionnaire - Core 30 (QLQ-C30)
Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Time frame
At baseline, 12 weeks, end of treatment, 1 year after end of treatment, 2 years after end of treatment and 3 years after end of treatment4
Quality of life questionnaire - Breast cancer module (QLQ-BR42)
This EORTC breast cancer specific questionnaire is intended to supplement the QLQ-C30. The QLQ-BR42 incorporates nine multi-item scales to assess body image, sexual functioning, breast satisfaction, systemic therapy side effects, arm symptoms, breast symptoms, endocrine therapy symptoms, skin mucosis symptoms, endocrine sexual symptoms. In addition, single items assess sexual enjoyment, future perspective and being upset by hair loss. All items are rated on a four-point Likert-type scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), and are linearly transformed to a 0-100 scale. Higher scores indicate more severe symptoms or problems for all items.
Time frame
At baseline, 12 weeks, end of treatment, 1 year after end of treatment, 2 years after end of treatment and 3 years after end of treatment Source ClinicalTrials.gov