Personalizing the Use of Pembrolizumab for Patients Who Have a Strong Response in Early Triple Negative Breast Cancer

NCT06606730 | Recruiting Phase 3 DMC

• 2 other identifiers: UC-BCG-24012024-515787-31-00
• Study Type: interventional
• Target: 2,454
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancers; Triple Negative Breast Cancer (TNBC)

Outcome Measures

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.

  From randomization to disease progression or death, up to 8 years.

Secondary Outcomes (14)

• Acute and late toxicity during the study

  Throughout study, up to 1 year.

• Patient reported outcome (PRO)-CTCAE composite score

  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

• Quality of life questionnaire - Core 30 (QLQ-C30)

  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

• Quality of life questionnaire - Breast cancer module (QLQ-BR42)

  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

• The developed 5-level version of EQ-5D (EQ-5D-5L)

  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

Study Arms (2)

Control

OTHER

Administration of pembrolizumab for 6 months

Drug: Pembrolizumab

Deescalation

EXPERIMENTAL

Patients will be followed up according to standard practice for 4 years

Other: Deescalation

Interventions

Pembrolizumab DRUG

Administration of pembrolizumab for 6 months

Also known as: Keytruda

Control

Deescalation OTHER

Patients will be followed up according to standard practice for 4 years

Deescalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Estrogen receptor (ER) and Progesterone receptor (PR) ≤10%; HER2-negative as per ASCO/CAP guidelines Note: In case of bilateral breast cancer, participation in the study is permitted as long as both tumours are triple negative;
• Patients previously treated with neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles (All systemic chemotherapy must have been completed preoperatively);
• Absence of residual invasive disease in the breast or lymph nodes after the completion of neoadjuvant therapy (Residual ductal carcinoma in situ \[DCIS\] is allowed);
• Have had an adequately excised breast cancer (surgical removal of all clinically evident disease in the breast and lymph nodes) :
• Breast surgery: patients must have undergone either breast-conserving surgery or total mastectomy with histologically negative margins for invasive tumour and DCIS. Patients with margins positive for lobular carcinoma in situ (LCIS) are eligible without additional resection.
• Lymph node surgery: patients must have had sentinel lymph node biopsy (SLNB) and/or axillary lymph node dissection (ALND) to evaluate the pathologic nodal status;
• Patients that have received adequate locoregional radiation therapy or with planned adequate locoregional radiation therapy;
• Adequate organ and bone marrow functions. All screening lab tests should be performed within 28 days before randomisation;
• Absolute Neutrophil Count (ANC) ≥ 1,000 /µL
• Platelets ≥ 100,000 /µL
• Hemoglobin ≥ 9 g/dL

You may not qualify if:

• 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;
• Patients for whom pembrolizumab has been permanently discontinued during the neoadjuvant phase of treatment due to pembrolizumab-related AE;
• History of intolerance, including Grade 3 or 4 infusion reaction or hypersensitivity to pembrolizumab or murine proteins or any component of the product;
• Medical conditions that require chronic systemic steroids (\> 10 mg prednisone or equivalent) or any other form of immunosuppressive medication in the past 2 years. Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment;
• Known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis;
• HIV-infected patients on effective anti-retroviral therapy with detectable viral load within 6 months prior to enrollment;
• Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better;
• Patients unwilling or unable to comply with the medical follow-up required by the trial due to geographic, familial, social, or psychological reasons;
• Persons deprived of their liberty or under protective custody or guardianship;
• Participation in another therapeutic trial within the 30 days prior to randomisation.

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (2)

Cliniques Universitaires Saint Luc Brussels

Brussels, 1200, Belgium

RECRUITING

Institut Gustave Roussy

Villejuif, 94805, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Joana Mourato Ribiero

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonia Mardinian

CONTACT

+33 6 98 54 96 60; s-mardinian@unicancer.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 23, 2024
• Study Start: July 23, 2025
• Primary Completion (Estimated): January 1, 2033
• Study Completion (Estimated): June 1, 2039
• Last Updated: August 26, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); FR (1)