NCT06606730

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

OPTimizing Adjuvant Prescription of PEMBROlizumab in Patients With Early-stage Triple-negative Breast Cancer Achieving Pathologic Complete Response After Standard Neoadjuvant Chemotherapy and Pembrolizumab

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,454 (estimated)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Triple-negative breast cancer is a particular type of breast cancer in which the cancer cells do not possess receptors for the proteins estrogen, progesterone, or HER2. The usual treatment for early-stage triple-negative breast cancer consists of chemotherapy and immunotherapy (a treatment (in this case, pembrolizumab) designed to stimulate the body's immune defenses against cancer cells) for 6 months before surgery, followed by a further 6 months of immunotherapy after surgery. Although this sequence is the reference treatment, the addition of an immunotherapy extension after surgery may not bring any additional benefit in patients who have had an excellent response to neoadjuvant treatment (before surgery), demonstrated by tumor disappearance at the time of surgery, and who therefore have a good prognosis.

Conditions

• Breast Cancers
• Triple Negative Breast Cancer (TNBC)

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Administration of pembrolizumab for 6 months
OTHER	Deescalation	Patients will be followed up according to standard practice for 4 years

Timeline

• Start date: 2025-07-23
• Primary completion: 2033-01-01
• Completion: 2039-06-01
• First posted: 2024-09-23
• Last updated: 2025-08-26

Locations

2 sites across 2 countries: Belgium, France