Trial · NCT02971748
Pembrolizumab in Treating Patients With Hormone Receptor Positive, Localized Inflammatory Breast Cancer Who Are Receiving Hormone Therapy and Did Not Achieve a Pathological Complete Response to Chemotherapy
NCT02971748, Phase 2, Active not recruiting, M.D. Anderson Cancer Center; results first posted 2026-01-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pembrolizumab in Treating Patients With Hormone Receptor Positive, Localized Inflammatory Breast Cancer Who Are Receiving Hormone Therapy and Did Not Achieve a Pathological Complete Response to Chemotherapy. Trials, record NCT02971748. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02971748
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Pembrolizumab in Treating Patients With Hormone Receptor Positive, Localized Inflammatory Breast Cancer Who Are Receiving Hormone Therapy and Did Not Achieve a Pathological Complete Response to Chemotherapy
- NCT number
- NCT02971748
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Breast Inflammatory Carcinoma, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8
- Interventions
- Pembrolizumab
- First posted
- 2016-11-23
- Last updated
- 2026-06-11
- Results first posted
- 2026-01-22
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Free Survival (DFS) | From treatment initiation through last available follow-up (up to approximately 9 years) | Disease-free survival (DFS) is defined as the time from treatment initiation to recurrence of disease or death from any cause. Patients without an event were censored at their last disease assessment. |
| Primary | Participants With Treatment-Related Adverse Events | From first dose through 30 days after last dose (up to approximately 25 months) | Number of participants experiencing treatment-related adverse events, graded according to CTCAE v4.0. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease Free Survival (DFS) | From treatment initiation through last available follow-up (up to approximately 9 years) | All treated patients were included in the DFS analysis. | years | MEDIAN |
| PRIMARY | Participants With Treatment-Related Adverse Events | From first dose through 30 days after last dose (up to approximately 25 months) | All treated patients were included in the safety analysis. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease Free Survival (DFS) | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | 4.22 | 95% Confidence Interval 2.17 to NA | years | |
| Participants With Treatment-Related Adverse Events | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | Abdominal pain | 1 | Participants | |
| Participants With Treatment-Related Adverse Events | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | Alanine aminotransferase increased | 1 | Participants | |
| Participants With Treatment-Related Adverse Events | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | Anorexia | 1 | Participants | |
| Participants With Treatment-Related Adverse Events | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | Arthralgia | 7 | Participants | |
| Participants With Treatment-Related Adverse Events | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | Aspartate aminotransferase increased | 1 | Participants | |
| Participants With Treatment-Related Adverse Events | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | Colitis | 4 | Participants | |
| Participants With Treatment-Related Adverse Events | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | Cough | 2 | Participants | |
| Participants With Treatment-Related Adverse Events | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | Diarrhea | 3 | Participants | |
| Participants With Treatment-Related Adverse Events | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | Dry mouth | 1 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | 31 | |
| Overall Study | COMPLETED | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | 8 | |
| Overall Study | NOT COMPLETED | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | 23 |
Source ClinicalTrials.gov
Adverse events82
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 | Hypothyroidism | Endocrine disorders | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | 9 | 31 | |
| other | Eye pain | Eye disorders | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | 1 | 31 | |
| other | Retinal vascular disorder | Eye disorders | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | 1 | 31 | |
| other | Abdominal pain | Gastrointestinal disorders | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | 2 | 31 | |
| other | Bloating | Gastrointestinal disorders | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | 1 | 31 | |
| other | Colitis | Gastrointestinal disorders | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | 2 | 31 | |
| other | Diarrhea | Gastrointestinal disorders | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | 3 | 31 | |
| other | Dry mouth | Gastrointestinal disorders | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | 1 | 31 | |
| other | Esophagitis | Gastrointestinal disorders | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | 1 | 31 | |
| other | Flatulence | Gastrointestinal disorders | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | 1 | 31 |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | 9 | 31 |
| Total, other adverse events | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | 28 | 31 |
| Total, serious adverse events | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | 6 | 31 |
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/NCT02971748
GET https://conductscience.org/api/trials/v1/NCT02971748/results?page=2