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  3. A012103/OPTIMICE-PCR

Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer

Short Title: A012103/OPTIMICE-PCR


Enrollment Status: Recruiting

NCT #: NCT05812807

Specialty Area: Oncology

Condition Studied: Triple Negative Breast Cancer

Age Groups: Adult; Older Adult

Phase: III


Study Information

Summary / Purpose

To find out if observation alone is as effective as continuing pembrolizumab in preventing breast cancer from returning in patients with early-stage triple-negative breast cancer who had a complete response to preoperative chemotherapy and pembrolizumab.

Study Type: Interventional
Accepts Healthy Volunteers: No

Who Can Participate

Eligibility Criteria:
  • Adults 18+ years of age
  • Diagnosed with early-stage triple-negative breast cancer (TNBC)
  • Stage I, II, or III
  • Achieved a complete response after receiving preoperative chemotherapy with pembrolizumab

What's Involved

Participation in the study will include:
  • Intravenous (IV) infusion of pembrolizumab or observation after surgery
  • Biopsies and biospecimen collection
  • Quality-of-life assessments
  • Blood and urine tests to monitor your health and treatment effects
  • Electrocardiogram (ECG) to monitor heart function
  • Questionnaires

Principal Investigator

Additional Information

Location: Renown Health, Office of Clinical Research
Address:

1500 E 2nd St. Reno, NV 89502

General Research: 775-982-3646
Oncology Research: 775-982-5050
Email: Renown-CRD@renown.org

Complete Study Details: https://clinicaltrials.gov/study/NCT05812807

Disclaimer: This listing gives you general information about the study and isn't part of the official consent process. If you decide to learn more, the research team will talk with you and check if you meet any additional requirements to join the study.

ER Wait Times

How are wait times calculated?

Our estimated ER wait times reflect the average time from check-in to being seen by a medical professional during triage, where patients are prioritized based on the severity of their condition.

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