Study Details

Open

A012103-CIRB: OPTIMICE-PCR: DE-ESCALATION OF THERAPY IN EARLY-STAGE TNBC PATIENTS WHO ACHIEVE PCR AFTER NEOADJUVANT CHEMOTHERAPY WITH CHECKPOINT INHIBITOR THERAPY

The purpose of this study is to compare the effectiveness of up to 27 weeks of post-surgical observation to up to 27 weeks of post-surgery pembrolizumab at reducing the risk of breast cancer coming back or death in patients with early-stage TNBC who achieved a pCR after preoperative chemotherapy in combination with pembrolizumab

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

If you decide to take part in this study, you will either get pembrolizumab for up to 27 weeks, or you will not receive any treatment and will be observed for up to 27 weeks. You will have labs, physical exams, imaging (mammogram), and questionnaires. After you finish your study treatment or observation period, your doctor will continue to follow your condition every 6 months for 5 years and watch you for side effects or cancer coming back. This means you will keep seeing your doctor for 5 years after treatment. After that, they will check on you every year for a total of 10 years after you enrolled on the study.

Incentives

Study Medication

Total length of participation:
You will receive treatment for up to 27 weeks. Follow up for up to 5 yrs

Looking for Specific Volunteers

Able to participate:

You have been diagnosed with early-stage triple negative breast cancer
You have received preoperative chemotherapy in combination with pembrolizumab for at least 6 cycles.
You have no residual breast cancer following the completion of preoperative chemotherapy.
You have received preoperative chemotherapy in combination with pembrolizumab for at least 6 cycles.
It has been less than 12 weeks since completing surgery before randomization for the clinical trial.

Not eligible if:

You have been diagnosed with metastatic breast cancer.
You are pregnant or breastfeeding a child.
Your breast cancer has returned following chemotherapy and surgery.
You have a known active liver disease.
You were not able to tolerate or have had a hypersensitivity to pembrolizumab in the past.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Yara Abdou
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Breast)

IRB Number

23-2085

ClinicalTrials.gov

NCT05812807