NCT05812807ClinicalTrials.gov

Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab

OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy

En recrutementAccepte des participants actuellement, selon la fiche du registre.

Contacter cette étude

En bref

Phase 31 295 participants recherchés846 sites3 pays

Catégories

Oncologie93%Immunologie et rhumatologie7%

Enregistré dans 1 registre

ClinicalTrials.govNCT05812807Ouvrir cette fiche sur ClinicalTrials.govSynchronisé il y a 2 mois

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2023-04-14; recorded start 2023-06-14
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Not stated: The record mentions a possible cost to participantsParsed from the study record (summary, description or eligibility text)
To compare patient out-of-pocket costs at approximately 27 weeks between patients randomized to adjuvant pembrolizumab versus observation.
Present: Sponsor has 95 other studies in this databaseCounted from the lead sponsor named in the record (Alliance for Clinical Trials in Oncology)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 4 conditions.
Lead sponsor type recorded as: other.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding0/20
Open-label
Control arm15/15
Active-comparator control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type10/10
Mortality / MACE endpoint (hard clinical outcome)
Multi-centre8/8
Multi-centre: 842 sites
Data monitoring committee0/7
No data monitoring committee stated
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 1,295 participants (target), run at 846 sites, across 3 countries.

How this score is built

Enrolment31/40
1,295 participants (target)
Site count25/25
842 sites
Country count7/15
3 countries
Planned duration10/10
Planned over about 121 months
Sponsor scale7/10
Alliance for Clinical Trials in Oncology has led 96 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Résumé

This phase III trial compares the effect of continuation of treatment with pembrolizumab (usual approach) to observation only at preventing cancer from coming back in patients with early-stage triple-negative breast cancer (TNBC) who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. The usual approach for patients with early-stage TNBC who receive preoperative chemotherapy plus pembrolizumab is to continue to receive pembrolizumab for up to 27 weeks after surgery. 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 is as good as receiving pembrolizumab for 27 weeks after surgery in triple-negative breast cancer patients who achieved a pathologic complete response after preoperative treatment with chemotherapy and pembrolizumab.

PRIMARY OBJECTIVES: I. To evaluate whether observation results in a non-inferior recurrence-free survival (RFS) compared to adjuvant pembrolizumab in early-stage triple-negative breast cancer (TNBC) patients who achieve a pathologic complete response (pCR) after neoadjuvant chemotherapy with pembrolizumab. II. To compare quality of life (QOL) at approximately 27 weeks as assessed by the Functional Assessment of Cancer Therapy-Breast (FACT-B) Trial Outcome Index between patients randomized to adjuvant pembrolizumab versus observation. (Quality of Life) III. To assess the social value of de-escalation of adjuvant breast cancer immunotherapy at approximately 27 weeks and, by modeling, over a lifetime. (Value of Care) SECONDARY OBJECTIVES: I. To evaluate whether observation compared to adjuvant pembrolizumab impacts the following: Ia. RFS by stage at presentation and by receipt of prior anthracycline therapy; Ib. Adverse event rate: difference in Grade 3 or higher adverse event rates overall and Grade 3 or higher immune-related adverse events (irAEs) rates; Ic. Overall Survival (OS); Id. Locoregional recurrence (LRR both isolated LRR as first events and LRR events simultaneous with distant metastases \[DM\]); Ie. RFS, LRR, OS, adverse events, and QOL by age (=\< 45, 46-65, and \> 65), race, and ethnicity; If. Adverse events related to receipt of radiotherapy. II. To assess the value of de-escalation of breast cancer immunotherapy from the payer perspective at approximately 27 weeks and, by modelling, over a lifetime. (Value of Care) III. To compare patient out-of-pocket costs at approximately 27 weeks between patients randomized to adjuvant pembrolizumab versus observation. (Value of Care) IV. To compare financial toxicity at approximately 27 weeks between patients randomized to adjuvant pembrolizumab versus observation. (Value of Care) V. To compare work/productivity impairment at approximately 27 weeks between patients randomized to adjuvant pembrolizumab versus observation. (Value of Care) EXPLORATORY OBJECTIVES: I. To describe trajectories of QOL over time among patients randomized to adjuvant pembrolizumab versus (vs.) observation. (Quality of Life) II. To compare various QOL domains after approximately 27 weeks as assessed by the 5 subscales of the FACT-B Index between patients randomized to adjuvant pembrolizumab versus observation. (Quality of Life) III. To compare self-reported symptomatic adverse events at approximately 27 weeks assessed by the patient reported outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) between patients randomized to adjuvant pembrolizumab versus observation. (Quality of Life) IV. To describe trajectories of financial toxicity and work/productivity impairment over time from baseline to approximately 27 weeks among patients randomized to adjuvant pembrolizumab versus observation. (Value of Care) V. To develop and assess a measure of value from the patient perspective at approximately 27 weeks. (Value of Care) OUTLINE: Patients are randomized to 1 of 2 arms after completing neoadjuvant chemotherapy in combination with pembrolizumab, followed by definitive breast surgery. ARM I (PEMBROLIZUMAB): Patients receive pembrolizumab intravenously (IV) over 25-40 minutes once every 3 weeks (Q3W) or once every 6 weeks (Q6W) for 27 weeks. Patients also undergo tumor biopsy and collection of blood throughout the study. Patients also undergo mammography, breast ultrasound or magnetic resonance imaging (MRI) during follow-up. ARM II (OBSERVATION): Patients undergo observation for 27 weeks. Patients also undergo tumor biopsy and collection of blood throughout the study. Patients also undergo mammography, breast ultrasound or MRI during follow-up.

Affections

Anatomic Stage II Breast Cancer AJCC v8
Early Stage Triple-Negative Breast Carcinoma
Anatomic Stage IIIA Breast Cancer AJCC v8
Anatomic Stage IIIB Breast Cancer AJCC v8

Éligibilité

Éligibilité
Sexe	Tous
Âges	18 Years – Aucun maximum
Volontaires sains	Non

Éligibilité telle qu'elle figure dans le registre

Inclusion Criteria: * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 * Triple Negative Breast Cancer: * Patients with a history of clinical stage T1cN1-2 or T2-4N0-2 (clinical stage II or III prior to preoperative therapy) breast cancer at time of diagnosis according to the primary tumor-regional lymph node anatomic staging criteria of the American Joint Committee on Cancer (AJCC), 8th edition as determined by the investigator in radiologic assessment, clinical assessment or both * Patients must have no residual invasive disease in the breast or lymph nodes after the completion of neoadjuvant therapy. Residual ductal carcinoma in situ (DCIS) is allowed. Isolated tumor cells are considered node-negative * Estrogen receptor (ER) and progesterone receptor (PR) =\< 10%; HER2-negative by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines (immunohistochemistry \[IHC\] and fluorescence in situ hybridization \[FISH\]) * If invasive disease was present in both breasts, participation in the study is permitted as long as the eligibility criteria are met for both tumors/breasts * Patients must have received neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles. All systemic chemotherapy must have been completed preoperatively * An interval of no more than 12 weeks between the completion date of the final surgery and the date of randomization \* Note: Adjuvant radiation can be given on study, however, it is recommended to complete adjuvant radiation prior to registration. If radiation is given on study, it is encouraged to be given concurrently with pembrolizumab if the patient is on the pembrolizumab arm, per investigator discretion. Treatment with adjuvant pembrolizumab is strongly discouraged prior to participation in this trial, but if administered (e.g., if patients are awaiting pathology results), pembrolizumab may be administered for up to 6 weeks (i.e., up to 2 q3week doses or up to one q6week dose) post-surgery and must be completed prior to registration post-surgery and must be completed prior to registration * Use of investigational anti-cancer agents must be discontinued at time of registration * Adequate excision: Surgical removal of all clinically evident disease in the breast and lymph nodes as follows: * Breast surgery: Total mastectomy or breast-conserving surgery with histologically negative margins, including no ink on tumor for DCIS, at the time of excision \*\* For patients who undergo breast-conserving surgery, the margins of the resected specimen must be histologically free of ductal carcinoma in-situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates DCIS at the line of resection, additional operative procedures may be performed to obtain clear margins. If DCIS is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. Patients with margins positive for classic lobular carcinoma in situ (LCIS) are eligible without additional resection * Lymph node surgery: * For a patient with clinically N0 disease, a sentinel lymph node biopsy should have been performed at time of surgical evaluation, and if pathologically node positive, the patient is no longer eligible. Isolated tumor cells are considered node-negative * For a patient with clinically N1 disease at diagnosis (with positive results from a fine-needle aspiration, core biopsy, or sentinel node biopsy performed prior to preoperative therapy) additional surgical evaluation of the axilla following preoperative therapy is required \*\*\* If they become cN0 (no palpable adenopathy), then a sentinel lymph node biopsy could have been performed at time of surgery (axillary dissection would also be permitted); if the sentinel lymph node biopsy is positive, the patient is no longer eligible * If sentinel node biopsy performed before preoperative therapy was negative, no additional surgical evaluation of the axilla is required after preoperative therapy. If sentinel node biopsy performed before preoperative therapy was positive, an ALND is required after preoperative therapy * If the only sentinel node identified by isotope scan is in the internal mammary chain, surgical evaluation of the axilla is still required * If sentinel node evaluation after preoperative therapy is negative, no further additional surgical evaluation of the axilla is required * Axillary dissection without sentinel node evaluation is permitted as the initial or sole axillary evaluation after preoperative therapy * If breast-conserving surgery was performed but patient will not be receiving breast radiation, the patient is not eligible * Not pregnant and not nursing, because this study involves an agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test done =\< 7 days prior to randomization is required * Absolute neutrophil count (ANC) \>= 1,000/mm\^3 * Platelet Count \>= 100,000/mm\^3 * Estimated glomerular filtration rate (eGFR) \>= 15 mL/min/1.73m\^2 * Total Bilirubin =\<1.5 x upper limit of normal (ULN) \* Patients with Gilbert's disease with a total bilirubin =\< 2.5 x ULN and direct bilirubin within normal limits are permitted * Aspartate aminotransferase (AST) serum aspartate aminotransferase \[SGOT\] / alanine aminotransferase (ALT) serum glutamic pyruvic transaminase \[SGPT\] =\< 3 x institutional ULN * Patients must be willing to provide tumor tissue from the diagnostic core biopsy. If inadequate tumor tissue is available, patients are still eligible to participate in the trial * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better * Patients with known HIV infection who are on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial Exclusion Criteria: * No stage IV (metastatic) breast cancer * No history of any prior (ipsi- or contralateral) invasive breast cancer. Prior DCIS is allowed * No evidence of recurrent disease following preoperative therapy and surgery * No known active liver disease, e.g. due to hepatitis B virus (HBV), hepatitis C virus (HCV), autoimmune hepatic disorders, or sclerosing cholangitis * No history of intolerance, including Grade 3 or 4 infusion reaction or hypersensitivity to pembrolizumab or murine proteins or any components of the product \* Note: Prior immune-related adverse events (irAEs) are allowed if they resolved to ≤ grade 1 and the patient tolerated subsequent therapy without requiring chronic steroids for the irAE. The following are exceptions to this criterion: Grade 2 or lower immune mediated endocrinopathies due to neoadjuvant checkpoint inhibition but patients are stable on endocrine therapy and were able to continue checkpoint inhibition. * No medical conditions that require chronic systemic steroids (\>10 mg prednisone daily or equivalent) or any other form of immunosuppressive medications and has required such therapy in the last two years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic therapy * Patients who are unable or unwilling to comply with the requirements of the protocol per investigator assessment are not eligible

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Conception de l'étude
Type d'étude	Interventionnelle
Phase	Phase 3
Répartition	Randomisée
Modèle d'intervention	PARALLEL
Objectif principal	TREATMENT
Insu	NONE (0)
Recrutement	1 295 participants recherchés

Promoteur et collaborateurs

Alliance for Clinical Trials in Oncology Promoteur
National Cancer Institute (NCI) Collaborateurs

Groupes et interventions

Arm I (pembrolizumab)ACTIVE_COMPARATOR
Patients receive pembrolizumab IV over 25-40 minutes Q3W or Q6W for 27 weeks. Patients also undergo tumor biopsy and collection of blood throughout the study. Patients also undergo mammography, breast ultrasound or MRI and during follow-up.
Arm II (observation)EXPERIMENTAL
Patients undergo observation for 27 weeks. Patients also undergo tumor biopsy and collection of blood throughout the study. Patients also undergo mammography, breast ultrasound or MRI during follow-up.

Interventions

Intervention Biopsy
Undergo biopsy
Intervention Biospecimen Collection
Undergo collection of blood
Autre Patient Observation
Undergo observation
Produit biologique Pembrolizumab
Given IV
Autre Quality-of-Life Assessment
Ancillary studies
Autre Questionnaire Administration
Ancillary studies

Critères de jugement

Critère de jugement principal
Recurrence-free survival (RFS)
Defined as the time from randomization to first invasive local, regional, or distant recurrence or death due to any cause. RFS will be compared between treatment arms using the hazard ratio (with 90% confidence interval and stratified log-rank test) from a stratified Cox model.
Délai Up to 10 years.
Critère de jugement secondaire
Incidence of adverse events (AEs)
Adverse events will be determined using the latest version of the Common Terminology Criteria for Adverse Events (CTCAE). The proportions of patients with a grade 3 or higher AE will be compared between the arms using a chi-square test. A similar analysis will be done to compare the grade 3 or higher irAE rates
Délai Up to 27 weeks after registration
Critère de jugement secondaire
Overall survival
Defined as the time from randomization to death due to any cause. OS will be compared between treatment arms using the hazard ratio (and stratified log-rank test) from a stratified Cox model
Délai Up to 10 years.
Critère de jugement secondaire
Locoregional recurrence incidence
Defined as the time from randomization to first invasive local or regional recurrence. The cumulative incidence of LRR will be compared between treatment arms using a log-rank test (and estimated using Kaplan-Meier curves).
Délai Up to 10 years.
Critère de jugement secondaire
Radiation adverse events
Radiation adverse events include pneumonitis, hypothyroidism and dermatitis. Radiation AE event rates will be determined for patients who received radiation. The numerator is the number of patients with the radiation AE and the denominator is the number of patients who received radiation. The analysis of the radiation related adverse event rates will only include patients who received radiation treatment. The radiation AE rates will be compared between the two arms using a chi-square test.
Délai Up to 27 weeks after registration

Dates

Dates
Date de début	14 juin 2023 (réelle)
Achèvement principal	31 mai 2033 (estimée)
Achèvement	31 mai 2033 (estimée)
Première publication	14 avril 2023 (réelle)
Dernière mise à jour	5 août 2026
Résultats publiés	Non précisé dans la fiche du registre
Statut vérifié pour la dernière fois	août 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

797 sites sont en recrutement

Canada

Canada
Établissement	Ville	État ou région	Statut
Cambridge Memorial Hospital	Cambridge	Ontario	En recrutement
BCCA-Cancer Centre for the Southern Interior	Kelowna	British Columbia	En recrutement
Kingston Health Sciences Centre	Kingston	Ontario	En recrutement
London Regional Cancer Program	London	Ontario	En recrutement
Jewish General Hospital	Montreal	Quebec	En recrutement
Ottawa Hospital and Cancer Center-General Campus	Ottawa	Ontario	En recrutement
CHU de Quebec-Hopital du Saint-Sacrement (HSS)	Québec	Quebec	En recrutement
Allan Blair Cancer Centre	Regina	Saskatchewan	En recrutement
Atlantic Health Sciences Corporation-Saint John Regional Hospital	Saint John	New Brunswick	En recrutement
Saskatoon Cancer Centre	Saskatoon	Saskatchewan	En recrutement
Odette Cancer Centre- Sunnybrook Health Sciences Centre	Toronto	Ontario	En recrutement
University Health Network-Princess Margaret Hospital	Toronto	Ontario	En recrutement
Centre Hospitalier Regional de Trois-Rivieres	Trois-Rivières	Quebec	En recrutement
BCCA-Vancouver Cancer Centre	Vancouver	British Columbia	En recrutement

Puerto Rico

Puerto Rico
Établissement	Ville	Statut
Doctors Cancer Center	Manati	En recrutement
PROncology	San Juan	En recrutement
Centro Comprensivo de Cancer de UPR	San Juan	En recrutement
San Juan City Hospital	San Juan	En recrutement

United States

United States
Établissement	Ville	État ou région	Statut
Avera Cancer Institute-Aberdeen	Aberdeen	South Dakota	En recrutement
Summa Health System - Akron Campus	Akron	Ohio	En recrutement
Phoebe Putney Memorial Hospital	Albany	Georgia	Suspendu
Atrium Health Stanly/LCI-Albemarle	Albemarle	North Carolina	En recrutement
University of New Mexico Cancer Center	Albuquerque	New Mexico	En recrutement
Presbyterian Kaseman Hospital	Albuquerque	New Mexico	En recrutement
Lehigh Valley Hospital-Cedar Crest	Allentown	Pennsylvania	En recrutement
AdventHealth Altamonte	Altamonte Springs	Florida	Actif, sans recrutement
Community Hospital of Anaconda	Anaconda	Montana	En recrutement
Katmai Oncology Group	Anchorage	Alaska	En recrutement
UI Health Care Mission Cancer and Blood - Ankeny Clinic	Ankeny	Iowa	En recrutement
University of Michigan Rogel Cancer Center	Ann Arbor	Michigan	En recrutement
Trinity Health Saint Joseph Mercy Hospital Ann Arbor	Ann Arbor	Michigan	En recrutement
Luminis Health Anne Arundel Medical Center	Annapolis	Maryland	En recrutement
Aspirus Cancer Care-Antigo-Volm Cancer Center	Antigo	Wisconsin	En recrutement
ThedaCare Regional Cancer Center	Appleton	Wisconsin	En recrutement
Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton	Appleton	Wisconsin	En recrutement
PCR Oncology	Arroyo Grande	California	En recrutement
Mission Hope Medical Oncology - Arroyo Grande	Arroyo Grande	California	En recrutement
Cone Health MedCenter Asheboro	Asheboro	North Carolina	En recrutement
Cone Health Cancer Center at Asheboro	Asheboro	North Carolina	Suspendu
Duluth Clinic Ashland	Ashland	Wisconsin	En recrutement
OhioHealth O'Bleness Hospital	Athens	Ohio	En recrutement
University Cancer and Blood Center LLC	Athens	Georgia	Suspendu
Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia	En recrutement
Emory Saint Joseph's Hospital	Atlanta	Georgia	En recrutement
Emory University Hospital Midtown	Atlanta	Georgia	En recrutement
Northside Hospital	Atlanta	Georgia	En recrutement
Grady Health System	Atlanta	Georgia	En recrutement
Augusta Oncology Associates PC-Wheeler	Augusta	Georgia	Suspendu
Augusta Oncology Associates PC-D'Antignac	Augusta	Georgia	Suspendu
Rush-Copley Medical Center	Aurora	Illinois	En recrutement

796 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

5 août 2026
Site ajouté
4 sites added (846 total)
842846

Registre: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT05812807