Trial · NCT02411656
Pembrolizumab in Treating Patients With Stage IV Metastatic or Recurrent Inflammatory Breast Cancer or Triple-Negative Breast Cancer Who Have Achieved Clinical Response or Stable Disease to Prior Chemotherapy
NCT02411656, Phase 2, Active not recruiting, M.D. Anderson Cancer Center; results first posted 2025-07-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pembrolizumab in Treating Patients With Stage IV Metastatic or Recurrent Inflammatory Breast Cancer or Triple-Negative Breast Cancer Who Have Achieved Clinical Response or Stable Disease to Prior Chemotherapy. Trials, record NCT02411656. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02411656
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Pembrolizumab in Treating Patients With Stage IV Metastatic or Recurrent Inflammatory Breast Cancer or Triple-Negative Breast Cancer Who Have Achieved Clinical Response or Stable Disease to Prior Chemotherapy
- NCT number
- NCT02411656
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 71 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
Edema, Erythema, Estrogen Receptor Negative, HER2/Neu Negative, Peau d'Orange, Progesterone Receptor Negative, Recurrent Inflammatory Breast Carcinoma, Stage IV Inflammatory Breast Carcinoma, Triple-Negative Breast Carcinoma
- Interventions
- Laboratory Biomarker Analysis, Pembrolizumab
- First posted
- 2015-04-08
- Last updated
- 2026-07-15
- Results first posted
- 2025-07-02
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To Assess the Efficacy of Pembrolizumab as a Single Agent in Patients With Metastatic IBC or Non-IBC TNBC | 4 months from the start of therapy | 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. |
| Other | Correlation Between PD-L1 IHC Status and Overall Survival in Patients Treated With Pembrolizumab | From the first dose of pembrolizumab up to 5 years | 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). |
| Other | Correlation Between PD-L1 IHC Status and Progression-Free Survival in Patients Treated With Pembrolizumab | From the first dose of pembrolizumab up to 3 years | 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). |
| Other | 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. | Baseline | RNA-sequencing will be performed with RNA extracted from plasma at baseline. |
| Other | Overall Survival for IBC or Non-IBC TNBC Patients Treated With Pembrolizumab | From registration date to up to 5 years | Overall survival time from the registration date was estimated using Kaplan-Meier method. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | To Assess the Efficacy of Pembrolizumab as a Single Agent in Patients With Metastatic IBC or Non-IBC TNBC | 4 months from the start of therapy | Patients who received a total of at least 2 cycles of pembrolizumab were analyzed. Two patients were excluded because they discontinued the study treatment due to toxicity after one dose. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Correlation Between PD-L1 IHC Status and Overall Survival in Patients Treated With Pembrolizumab | From the first dose of pembrolizumab up to 5 years | The patients with tumor samples available | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Correlation Between PD-L1 IHC Status and Progression-Free Survival in Patients Treated With Pembrolizumab | From the first dose of pembrolizumab up to 3 years | The patients with tumor samples available | months | MEDIAN |
| OTHER_PRE_SPECIFIED | 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. | Baseline | No data is available. As a result, no participants were included in this outcome measure analysis. | ||
| OTHER_PRE_SPECIFIED | Overall Survival for IBC or Non-IBC TNBC Patients Treated With Pembrolizumab | From registration date to up to 5 years | Patients who received a total of at least 2 cycles of pembrolizumab were analyzed. | years | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| To Assess the Efficacy of Pembrolizumab as a Single Agent in Patients With Metastatic IBC or Non-IBC TNBC | Treatment (Pembrolizumab) | 58.1 | percentage of participants | ||
| Correlation Between PD-L1 IHC Status and Overall Survival in Patients Treated With Pembrolizumab | PD-L1 Negative | 26.0 | 95% Confidence Interval 13.3 to 55.9 | months | |
| Correlation Between PD-L1 IHC Status and Overall Survival in Patients Treated With Pembrolizumab | PD-L1 Positive | 31.9 | 95% Confidence Interval 9.2 to NA | months | |
| Correlation Between PD-L1 IHC Status and Progression-Free Survival in Patients Treated With Pembrolizumab | PD-L1 Negative | 3.9 | 95% Confidence Interval 2.5 to 6.5 | months | |
| Correlation Between PD-L1 IHC Status and Progression-Free Survival in Patients Treated With Pembrolizumab | PD-L1 Positive | 5.7 | 95% Confidence Interval 3.4 to NA | months | |
| Overall Survival for IBC or Non-IBC TNBC Patients Treated With Pembrolizumab | Treatment (Pembrolizumab) | 2.17 | 95% Confidence Interval 1.11 to 3.19 | years |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Pembrolizumab) | 45 | |
| Overall Study | COMPLETED | Treatment (Pembrolizumab) | 8 | |
| Overall Study | NOT COMPLETED | Treatment (Pembrolizumab) | 37 |
Source ClinicalTrials.gov
Adverse events84
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Treatment (Pembrolizumab) | 6 | 45 | |
| other | Alanine aminotransferase increased | Investigations | Treatment (Pembrolizumab) | 5 | 45 | |
| other | Alkaline phosphatase increased | Investigations | Treatment (Pembrolizumab) | 6 | 45 | |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Treatment (Pembrolizumab) | 4 | 45 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Treatment (Pembrolizumab) | 4 | 45 | |
| other | Anemia | Blood and lymphatic system disorders | Treatment (Pembrolizumab) | 3 | 45 | |
| other | Anorexia | Metabolism and nutrition disorders | Treatment (Pembrolizumab) | 4 | 45 | |
| other | Anxiety | Psychiatric disorders | Treatment (Pembrolizumab) | 3 | 45 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Treatment (Pembrolizumab) | 10 | 45 | |
| other | Aspartate aminotransferase increased | Investigations | Treatment (Pembrolizumab) | 3 | 45 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Pembrolizumab) | 34 | 45 |
| Total, other adverse events | Treatment (Pembrolizumab) | 40 | 45 |
| Total, serious adverse events | Treatment (Pembrolizumab) | 13 | 45 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02411656
GET https://conductscience.org/api/trials/v1/NCT02411656/events?page=2