Do You Know About These Breast Cancer Trials?

Photo Credit: Saicle

Breast cancer is the most common cancer in the United States, with more than 300,000 new cases estimated in 2025. In this article, Physician’s Weekly offers a roundup of current clinical trials investigating treatment regimens for patients with breast cancer.

The COMET Study

Trial: Comparing an Operation to Monitoring, With or Without Endocrine Therapy Trial For Low Risk DCIS
Condition: Low-risk ductal carcinoma in situ
Status: Active, not recruiting
Sponsor: Alliance Foundation Trials, LLC
ClinicalTrials.gov ID: NCT02926911

Overview: COMET is a pragmatic, prospective, randomized trial designed to elucidate the risks and benefits of active monitoring versus surgery among patients with low-risk DCIS.

The study notes that as many as one in four patients with breast cancer experience overdiagnosis and overtreatment, with DCIS contributing significantly to this burden. An estimated 40,000 patients with DCIS may not experience disease progression without treatment, and overtreatment with surgery incurs risks such as chronic pain, disability, and psychological distress.

The study hypothesizes that managing this patient population with active monitoring is non-inferior to surgery in terms of cancer and quality of life outcomes.

The OPT-PEMBRO Study

Trial: Personalizing the Use of Pembrolizumab for Patients Who Have a Strong Response in Early Triple Negative Breast Cancer
Condition: Triple-negative breast cancer
Status: Not yet recruiting
Sponsor: UNICANCER
ClinicalTrials.gov ID: NCT06606730

Overview: OPT-PEMBRO is a pragmatic, prospective, randomized, phase 3 trial. The researchers are examining whether patients with triple-negative breast cancer who have a complete response to neoadjuvant treatment have the same chance of avoiding recurrence if they stop pembrolizumab or continue receiving it for another 6 months.

Patients with early, triple-negative breast cancer usually receive chemotherapy and immunotherapy for 6 months both pre- and post-surgery. The current study speculates that post-surgery immunotherapy treatment may not offer any benefit to patients who have an excellent response to pre-surgical treatment, tumor disappearance, and a good prognosis.

The OPT-PEMBRO study will also gather data on treatment tolerance and patients’ quality of life.

The BRIA-ABC Study

Trial: Study of the Bria-IMT Regimen and CPI vs Physicians’ Choice in Advanced Metastatic Breast Cancer
Condition: Advanced metastatic or locally recurrent breast cancer
Status: Recruiting
Sponsor: BriaCell Therapeutics Corporation
ClinicalTrials.gov ID: NCT06072612

Overview: BRIA-ABC is a randomized, open-label study examining overall survival in patients with advanced metastatic or locally recurrent breast cancer who receive either a) the Bria-IMT regimen plus the checkpoint inhibitor retifanlimab or b) treatment of the patient/physician’s choice. The researchers will also compare Bria-IMT alone versus Bria-IMT with the checkpoint inhibitor. Patients will be randomly assigned 1:1:1 to each treatment group.

The Bria-IMT regimen includes the immunotherapy agent SV-BR-1-GM in combination with cyclophosphamide and interferon.

The CAMBRIA-2 Study

Trial: An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/​HER2- Early Breast Cancer
Condition: ER+, HER2- early breast cancer
Status: Recruiting
Sponsor: AstraZeneca
ClinicalTrials.gov ID: NCT05952557

Overview: CAMBRIA-2 is a phase 3, open-label study designed to compare invasive breast cancer-free survival with either camizestrant or standard adjuvant endocrine therapy in patients with ER+, HER2- early breast cancer. Patients enrolling in this study must have intermediate-high or high risk for recurrence and must have completed definitive locoregional therapy with or without chemotherapy. The study notes that patients in both arms are allowed to receive concurrent abemaciclib.

The study plans for a treatment duration of 7 years in either arm, as well as 10 years of follow-up from when the last patient is randomly assigned to treatment. Secondary endpoints include invasive disease-free survival, distant relapse-free survival, overall survival, and safety and clinical outcome assessments.