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

StatusRecruiting
PhasePhase 3
Started2023-06-14
View on ClinicalTrials.gov ↗

Amendment history

2026-08-04
Study Status, Contacts/Locations v24
Trial sites expanded: 842 → 846 locations
2026-07-01
Study Status, Contacts/Locations v23
Trial sites expanded: 838 → 842 locations
2026-06-04
Study Status, Study Description, Conditions, Arms and Interventions, Eligibility, Contacts/Locations v22
Eligibility criteria+580 characters
[...] -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 [...] . Isolated tumor cells are considered node-negative Estrogen receptor (ER) and progesterone receptor (PR) =< 10%; HER2-negative by American Society of Clinical [...] izumab for a minimum of 6 cycles. All systemic chemotherapy and ICI therapy shouldmust have been completed preoperatively An interval of no more t [...] ndomization * Note: Adjuvant radiation can be g [...]
Study description+248 characters
[...] olated LRR as first events and LRR events simultaneous with distant metastases [DM]); Ie. RFS, LRR, OS, adverse events, and QOL by age (=< 45, [...] LIZUMAB): Patients receive pembrolizumab intravenously (IV) onover study25-40 minutes once every 3 weeks (Q3W) or once every 6 weeks (Q6W) for 27 weeks. Patients also undergo tumor biopsy on study, and collection of blood onthroughout the study. Patients andalso undergo mammography, breast ultrasound or magnetic resonance imaging (MRI) during follow-up. ARM II (OBSERVATION): Patients undergo observation onfor study27 weeks. Patients also undergo tumor b [...] [...]
Study sitesdetails revised at 1 of 838 sites
2026-06-01
Study Status, Contacts/Locations v21
Study sites836→838
2026-05-07
Study Status, Contacts/Locations v20
Study sites836 entries, revised
Cedars-Sinai Medical Center Northwest Cancer Center - MainCrown CampusPoint OptumCareMedStar CancerSouthern CareMaryland atHospital Seven HillsCenter
2026-04-06
Study Status, Contacts/Locations v19
Trial sites expanded: 829 → 836 locations
2026-03-02
Study Status, Contacts/Locations v18
Study sites826→829
2026-02-03
Study Status, Contacts/Locations v17
Study sites822→826
2026-01-06
Study Status, Contacts/Locations v16
Study sites812→822
2025-12-02
Study Status, Contacts/Locations v15
Study sites809→812
2025-11-04
Study Status, Contacts/Locations v14
Study sites794→809
2025-10-07
Study Status, Contacts/Locations v13
Study sites765→794
2025-08-28
Study Status, Contacts/Locations v12
Study sites743→765
2025-06-24
Study Status, Contacts/Locations v11
Study sites712→743
2025-03-28
Study Status, Contacts/Locations v10
Study sites668→712
2024-12-24
Study Status, Contacts/Locations v9
Study sites628→668
2024-10-24
Study Status, Contacts/Locations v8
Study sites616→628
2024-09-27
Study Status, Contacts/Locations v7
Start date2023-05-10→2023-06-14
Study sites590→616
2024-08-01
Study Status, Contacts/Locations v6
Study sites484→590
2024-04-08
Study Status, Contacts/Locations v5
Study sites438→484
2024-02-19
Study Status, Contacts/Locations v4
Study sites327→438
2023-10-30
Study Status, Contacts/Locations v3
Study sites154→327
2023-08-02
Study Identification, Study Status, Contacts/Locations v2
Study sites1→154
2023-05-31
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sites0→1
2023-04-12
Original filing
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.
Trial Details
NCT Number NCT05812807
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Conditions 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
Enrollment 1,295 participants
Start Date 2023-06-14
Primary Completion 2033-05-31 (estimated)
Study Completion 2033-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-05