A Phase 2 interventional study of Laboratory Biomarker Analysis and Pembrolizumab in Edema, Erythema and Estrogen Receptor Negative, sponsored by M.D. Anderson Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
This phase II trial studies how well pembrolizumab works in treating patients with stage IV inflammatory breast cancer or triple-negative breast cancer that has spread to other places in the body (metastatic) or has come back (recurrent), and who have achieved clinical response or stable disease to prior chemotherapy. 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.
PRIMARY OBJECTIVES:
Primary Objective: To assess the efficacy of MK-3475 as a single agent in patients with metastatic IBC or non-IBC TNBC
EXPLORATORY OBJECTIVES:
OUTLINE:
Patients receive pembrolizumab 200mg IV over approximately 30 minutes on day 1. Cycles repeat every 21 days for 8 cycles and then pembrolizumab 400mg IV every 42 days for total up to 24 months in the absence of disease progression or unacceptable toxicity
After completion of study treatment, patients are followed up at approximately 1 and 3 months.
Per RECIST criteria 1.1, Clinical response for measurable disease is defined as complete response (CR) or partial response (PR); for non-measurable disease only (i.e. bone metastasis, ascites, pleural effusion, and pathological lymph nodes >/= 10 to \<15 mm short axis) is defined as persistence of one or more non-target lesion(s) and no increase in overall tumor burden.
ANC >/= 1000 /mcL, Platelets >/=100,000 /mcL, Hgb >/= 9 g/dL, creatinine levels \< 1.5 x ULN, Total bilirubin \</= 1.5 x ULN, ALT and AST \</= 2.5 x ULN or \</=5 x ULN for participants with liver metastases.
Exclusion Criteria:
Patients receive pembrolizumab 200mg IV over approximately 30 minutes on day 1. Cycles repeat every 21 days for 8 cycles and then pembrolizumab 400mg IV every 42 days for total up to 24 months in the absence of disease progression or unacceptable toxicity
Other: Laboratory Biomarker Analysis · Biological: Pembrolizumab
Correlative studies
Given IV
Also known as: Keytruda, Lambrolizumab, MK-3475, SCH 900475
To Assess the Efficacy of Pembrolizumab as a Single Agent in Patients With Metastatic IBC or Non-IBC TNBC
The disease control rate (DCR) was assessed. The DCR was defined as the proportion of all treated patients with a lack of progression within 4 months as determined by radiologic imaging or clinical assessment.
Time frame: 4 months from the start of therapy
Correlation Between PD-L1 IHC Status and Overall Survival in Patients Treated With Pembrolizumab
PD-L1 satus in tumor tissue was determined by IHC analysis: positive CPS≥ 10, negative CPS \<10. Median OS and 95% confidence interval are estimated by the PD-L1 status in tumor tissue (positive vs. negative).
Time frame: From the first dose of pembrolizumab up to 5 years
Correlation Between PD-L1 IHC Status and Progression-Free Survival in Patients Treated With Pembrolizumab
PD-L1 expression in tumor tissue was assessed by immunohistochemistry (IHC), with CPS ≥10 defined as PD-L1 positive and CPS \<10 as PD-L1 negative.Median PFS and 95% confidence interval are estimated by the PD-L1 status in tumor tissue (positive vs. negative).
Time frame: From the first dose of pembrolizumab up to 3 years
To Investigate the Association Between Biomarkers and Efficacy by RNA-sequencing of Exosomes in Blood and Tumor for IBC or Non-IBC TNBC Patients Treated With Pembrolizumab.
RNA-sequencing will be performed with RNA extracted from plasma at baseline.
Time frame: Baseline
Overall Survival for IBC or Non-IBC TNBC Patients Treated With Pembrolizumab
Overall survival time from the registration date was estimated using Kaplan-Meier method.
Time frame: From registration date to up to 5 years
| Milestone | Treatment (Pembrolizumab) |
|---|---|
| Started | 45 |
| Completed | 8 |
| Not completed | 37 |
| Withdrew: Adverse event | 4 |
| Withdrew: Clinical progression | 33 |
The disease control rate (DCR) was assessed. The DCR was defined as the proportion of all treated patients with a lack of progression within 4 months as determined by radiologic imaging or clinical assessment.
| percentage of participants | Treatment (Pembrolizumab) |
|---|---|
| To Assess the Efficacy of Pembrolizumab as a Single Agent in Patients With Metastatic IBC or Non-IBC TNBC | 58.1 |
PD-L1 satus in tumor tissue was determined by IHC analysis: positive CPS≥ 10, negative CPS \<10. Median OS and 95% confidence interval are estimated by the PD-L1 status in tumor tissue (positive vs. negative).
| months | PD-L1 Negative | PD-L1 Positive |
|---|---|---|
| Correlation Between PD-L1 IHC Status and Overall Survival in Patients Treated With Pembrolizumab | 26.0 (13.3 to 55.9) | 31.9 (9.2 to NA) |
PD-L1 expression in tumor tissue was assessed by immunohistochemistry (IHC), with CPS ≥10 defined as PD-L1 positive and CPS \<10 as PD-L1 negative.Median PFS and 95% confidence interval are estimated by the PD-L1 status in tumor tissue (positive vs. negative).
| months | PD-L1 Negative | PD-L1 Positive |
|---|---|---|
| Correlation Between PD-L1 IHC Status and Progression-Free Survival in Patients Treated With Pembrolizumab | 3.9 (2.5 to 6.5) | 5.7 (3.4 to NA) |
RNA-sequencing will be performed with RNA extracted from plasma at baseline.
No measurements were reported for this outcome.
Overall survival time from the registration date was estimated using Kaplan-Meier method.
| years | Treatment (Pembrolizumab) |
|---|---|
| Overall Survival for IBC or Non-IBC TNBC Patients Treated With Pembrolizumab | 2.17 (1.11 to 3.19) |
Collected over All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Pembrolizumab) | 34/45 (75.6%) | 13/45 (28.9%) | 40/45 (88.9%) |
| Event | Treatment (Pembrolizumab) |
|---|---|
| Disease progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/45 |
| Adrenal insufficiencyEndocrine disorders | 2/45 |
| HeadacheNervous system disorders | 2/45 |
| HypothyroidismEndocrine disorders | 2/45 |
| InfectionInfections and infestations | 2/45 |
| Abdominal painGastrointestinal disorders | 1/45 |
| ColitisGastrointestinal disorders | 1/45 |
| ConstipationGastrointestinal disorders | 1/45 |
| DehydrationMetabolism and nutrition disorders | 1/45 |
| DiarrheaGastrointestinal disorders | 1/45 |
| Event | Treatment (Pembrolizumab) |
|---|---|
| NauseaGastrointestinal disorders | 20/45 |
| HeadacheNervous system disorders | 19/45 |
| FatigueGeneral disorders | 18/45 |
| MyalgiaMusculoskeletal and connective tissue disorders | 16/45 |
| CoughRespiratory, thoracic and mediastinal disorders | 15/45 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 15/45 |
| VomitingGastrointestinal disorders | 15/45 |
| DiarrheaGastrointestinal disorders | 13/45 |
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 12/45 |
| ConstipationGastrointestinal disorders | 11/45 |
| Age, Continuous(years) | Treatment (Pembrolizumab) |
|---|---|
| Median | 54 (34 to 77) |
| Sex: Female, Male(Participants) | Treatment (Pembrolizumab) |
|---|---|
| Female | 45 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Treatment (Pembrolizumab) |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 38 |
| Unknown or Not Reported | 3 |
| Race (NIH/OMB)(Participants) | Treatment (Pembrolizumab) |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 38 |
| More than one race | 4 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Treatment (Pembrolizumab) |
|---|---|
| United States | 45 |
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M.D. Anderson Cancer Center