--- title: "Adjuvant Breast Cancer A012103 OptimiCE-PCR | Sutter Health" description: "OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy" url: "https://www.sutterhealth.org/research/clinical-trials/adjuvant-breast-cancer-a012103-optimice-pcr-1094794503" --- 1. [Home](https://www.sutterhealth.org/) / 2. [Research](https://www.sutterhealth.org/research) / 3. [Clinical trials](https://www.sutterhealth.org/research/clinical-trials) / 4. Adjuvant Breast Cancer A012103 OptimiCE-PCR # Adjuvant Breast Cancer A012103 OptimiCE-PCR **Status:** Open to Enrollment [Email us to enroll](https://www.sutterhealth.org/research/clinical-trials/adjuvant-breast-cancer-a012103-optimice-pcr-1094794503#enroll) #### Study details View study details on [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05812807). #### Locations - Sutter Health System Wide #### Clinical trial FAQs Information for patients and study volunteers, including [frequently asked questions](https://www.sutterhealth.org/research/faqs). Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab. ![Uma Suryadevara, M.D.](https://dyn.mktgcdn.com/p/uTm9De_Et4uRHg7A6rYTiaGafphjbp8QnGTH11anoUI/fit=crop,gravity=auto,dpr=2,width=188,height=250,quality=100) Uma Suryadevara, M.D. Principal investigator [View profile](https://www.sutterhealth.org/research/investigators/uma-suryadevara-md-1049681015) ## Email us to enroll - [Email Sutter Health System Wide](mailto:ClinicalResearch%40sutterhealth.org?subject=More%20information%20on%20Adjuvant%20Breast%20Cancer%20A012103%20OptimiCE-PCR%20in%20Sutter%20Health%20System%20Wide&body=Please%20be%20aware%20that%20if%20you%20reply%20with%20unencrypted%20email%2C%20this%20increases%20the%20risk%20that%20information%20could%20be%20read%20by%20an%20unauthorized%20third%20party.%20Please%20do%20not%20include%20any%20Protected%20Health%20Information%20in%20your%20email%20response.) ## Related clinical trials [View all clinical trials](https://www.sutterhealth.org/research-search-results?verticalKey=clinical_trial) - Clinical trial ### [Adjuvant Breast Cancer ER-pos/HER2-neg EA1242](https://www.sutterhealth.org/research/clinical-trials/adjuvant-breast-cancer-er-pos-her2-neg-ea1242-2072227055) A Phase III Trial of Rx Therapy Guided by Genomic Risk Assessment for High Anatomic Stage ER-pos/HER2-neg Breast Cancer With RS≤25 (RxFINE-Low) **Status:** Open to Enrollment - Clinical trial ### [Adjuvant Breast NRG-BR009](https://www.sutterhealth.org/research/clinical-trials/adjuvant-breast-nrg-br009-1049142000) A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 (OFSET) **Status:** Open to Enrollment - Clinical trial ### [Adjuvant Triple NegativeBreast Cancer Ascent-05](https://www.sutterhealth.org/research/clinical-trials/adjuvant-triple-negative-breast-cancer-ascent-05-2022817141) A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy **Status:** Open to Enrollment - Clinical trial ### [Advanced Breast Cancer HR+ HER2- WO45654](https://www.sutterhealth.org/research/clinical-trials/advanced-breast-cancer-hr-her2-wo45654-2044043570) A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer **Status:** Open to Enrollment - Clinical trial ### [Advanced or Metastatic Breast Cancer C4551002](https://www.sutterhealth.org/research/clinical-trials/advanced-or-metastatic-breast-cancer-c4551002-2060622373) An Interventional, Open-Label, Randomized, Multicenter, Phase 3 Study of PF-07248144 Plus Fulvestrant Compared to Investigator's Choice of Therapy in Adult Participants With Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic Breast Cancer Whose Disease Progressed After Prior CDK4/6 Inhibitor-based Therapy **Status:** Open to Enrollment [View all clinical trials](https://www.sutterhealth.org/research-search-results?verticalKey=clinical_trial) ```json {"@context":"https://schema.org","@type":"MedicalOrganization","name":"Sutter Health","@id":"https://www.sutterhealth.org/#medicalorganization","url":"https://www.sutterhealth.org","logo":"https://www.sutterhealth.org/static/images/sutter-health-logo.svg","address":{"@type":"PostalAddress","streetAddress":"2200 River Plaza Drive","addressLocality":"Sacramento","addressRegion":"CA","postalCode":"95833","addressCountry":"US"},"areaServed":{"@type":"AdministrativeArea","name":"California"},"sameAs":["https://www.facebook.com/SutterHealth","https://www.instagram.com/sutterhealth/","https://x.com/SutterHealth","https://www.youtube.com/sutterhealth","https://www.linkedin.com/company/sutter-health","https://en.wikipedia.org/wiki/Sutter_Health"]} ``` ```json {"@context":"https://schema.org","@type":"BreadcrumbList","@id":"https://www.sutterhealth.org/research/clinical-trials/adjuvant-breast-cancer-a012103-optimice-pcr-1094794503#breadcrumblist","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https://www.sutterhealth.org/"},{"@type":"ListItem","position":2,"name":"Research","item":"https://www.sutterhealth.org/research"},{"@type":"ListItem","position":3,"name":"Clinical trials","item":"https://www.sutterhealth.org/research/clinical-trials"},{"@type":"ListItem","position":4,"name":"Adjuvant Breast Cancer A012103 OptimiCE-PCR"}]} ``` ```json {"@context":"https://schema.org","@type":"MedicalWebPage","@id":"https://www.sutterhealth.org/research/clinical-trials/adjuvant-breast-cancer-a012103-optimice-pcr-1094794503#medicalwebpage","name":"Adjuvant Breast Cancer A012103 OptimiCE-PCR","description":"OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy","url":"https://www.sutterhealth.org/research/clinical-trials/adjuvant-breast-cancer-a012103-optimice-pcr-1094794503","inLanguage":"en-US","dateModified":"2026-05-21","publisher":{"@type":"MedicalOrganization","name":"Sutter Health","@id":"https://www.sutterhealth.org/#medicalorganization","url":"https://www.sutterhealth.org"},"medicalAudience":{"@type":"MedicalAudience","audienceType":"Patient"},"mainEntity":{"@id":"https://www.sutterhealth.org/research/clinical-trials/adjuvant-breast-cancer-a012103-optimice-pcr-1094794503#medicaltrial"},"breadcrumb":{"@id":"https://www.sutterhealth.org/research/clinical-trials/adjuvant-breast-cancer-a012103-optimice-pcr-1094794503#breadcrumblist"},"mentions":[{"@type":"Person","name":"Uma Suryadevara, M.D.","url":"https://www.sutterhealth.org/research/investigators/uma-suryadevara-md-1049681015","jobTitle":"Principal Investigator","affiliation":{"@type":"MedicalOrganization","name":"Sutter Health","@id":"https://www.sutterhealth.org/#medicalorganization","url":"https://www.sutterhealth.org"}}]} ``` ```json {"@context":"https://schema.org","@type":"MedicalTrial","@id":"https://www.sutterhealth.org/research/clinical-trials/adjuvant-breast-cancer-a012103-optimice-pcr-1094794503#medicaltrial","name":"Adjuvant Breast Cancer A012103 OptimiCE-PCR","alternateName":"OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy","url":"https://www.sutterhealth.org/research/clinical-trials/adjuvant-breast-cancer-a012103-optimice-pcr-1094794503","description":"Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.","identifier":"NCT05812807","code":{"@type":"MedicalCode","codeValue":"NCT05812807","codingSystem":"ClinicalTrials.gov"},"sameAs":"https://clinicaltrials.gov/study/NCT05812807","status":"https://schema.org/Recruiting","healthCondition":[{"@type":"MedicalCondition","name":"Breast Cancer"}],"studyLocation":[{"@type":"AdministrativeArea","name":"Sutter Health System Wide"}]} ```