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Active, not recruitingNCT02411656Updated Jul 15, 2026Results posted

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

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

Phase
Phase 2
Study type
Interventional
Enrollment
71
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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:

  1. To investigate the association between biomarkers in the peripheral blood and tumor tissue, such as PD-L1 expression, with safety and efficacy for IBC or non-IBC TNBC patients treated with MK-3475.
  2. To determine the disease control rate of metastatic IBC or non-IBC TNBC patients who have achieved clinical response or stable disease to the systemic therapy.
  3. 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 MK-3475.
  4. To investigate the 5-year OS for IBC or non-IBC TNBC patients treated with MK-3475

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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Is willing and able to provide written informed consent for the trial
  • Is a female or male and >/= 18 years of age
  • Has histological confirmation of HER2 normal breast carcinoma with a clinical diagnosis of IBC based on presence of inflammatory changes in the involved breast, including diffuse erythema and edema (peau d'orange), with or without an underlying palpable mass involving the majority of the skin of the breast; pathological evidence of dermal lymphatic invasion should be noted but is not required for diagnosis of inflammatory breast cancer regardless estrogen receptor (ER)/progesterone receptor (PR) status; OR has histological confirmation of triple negative breast carcinoma (HER2 normal, ER/PR \< 10%) without clinical diagnosis of IBC
  • Has stage IV or recurrent disease that has been treated
  • Has clinical response or stable disease for minimum of two months (three cycles of every three week chemotherapy or 8 weeks of weekly regimen, etc.) after receiving any prior chemotherapy for metastatic/recurrent disease; a minimum of two cycles (6-8 weeks) of chemotherapy is required to determine clinical response.

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.

  • Is HER2 normal, defined as HER2 0 or 1+ by IHC and negative by FISH if performed; or HER2 is 2+ by IHC and negative by FISH; or HER2 negative by FISH if IHC is not performed.
  • Has a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
  • Has adequate organ function as determined by the following laboratory values:

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.

  • Participants of childbearing potential should be willing to use effective methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through at least 4 months after the last dose of study drug. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. Effective methods of birth control include 1). Use of hormonal birth control methods: pills, shots/injections, implants (placed under the skin by a health care provider), or patches (placed on the skin); 2).Intrauterine devices (IUDs); 3).Using 2 barrier methods (each partner must use 1 barrier method) with a spermicide. Males must use the male condom (latex or other synthetic material) with spermicide. Females must choose either a Diaphragm with spermicide, or Cervical cap with spermicide, or a sponge (spermicide is already in the contraceptive sponge).
  • Has negative serum or urine pregnancy test for participants of childbearing potential

Exclusion criteria

Exclusion Criteria:

  • Is currently participating in a study of an investigational anti-cancer agent
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy
  • Has not recovered from adverse events due to prior therapies, i.e. monoclonal antibody, chemotherapy, targeted small molecule therapy, radiation therapy, or surgery. (Note: Participants with ≤ grade 2 neuropathy, alopecia and general disorders and administration site conditions [per Common Terminology Criteria for Adverse Events (CTCAE version 4.0) are an exception to this criterion and may qualify for the study)
  • Has a known malignancy (other than breast cancer) except basal cell carcinoma or squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis; participants with previously treated brain metastases may participate if they are stable, and have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment
  • Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; participants with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Participants that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Participants with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study.
  • Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
  • Has an active infection requiring systemic therapy
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
  • Has a known history of human immunodeficiency virus (HIV)
  • Has a known active hepatitis B or hepatitis C
  • Have received a live vaccine within 30 days prior to the first dose of trial treatment
  • Is receiving concurrent anti-cancer therapy for metastatic disease
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
71 participants (actual)

Study arms

  • Experimental
    Treatment (pembrolizumab)

    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

Interventions

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • BiologicalPembrolizumab

    Given IV

    Also known as: Keytruda, Lambrolizumab, MK-3475, SCH 900475

05

What researchers measure

Primary outcomes

  1. 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

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

06

Results

Posted Jul 2, 2025

Participant flow

Participant flow — Overall Study
MilestoneTreatment (Pembrolizumab)
Started45
Completed8
Not completed37
Withdrew: Adverse event4
Withdrew: Clinical progression33

Outcome measures

PrimaryTo 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
Reported as:
Number · percentage of participants
To Assess the Efficacy of Pembrolizumab as a Single Agent in Patients With Metastatic IBC or Non-IBC TNBC
percentage of participantsTreatment (Pembrolizumab)
To Assess the Efficacy of Pembrolizumab as a Single Agent in Patients With Metastatic IBC or Non-IBC TNBC58.1
Other pre-specifiedCorrelation 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
Reported as:
Median · months
Correlation Between PD-L1 IHC Status and Overall Survival in Patients Treated With Pembrolizumab
monthsPD-L1 NegativePD-L1 Positive
Correlation Between PD-L1 IHC Status and Overall Survival in Patients Treated With Pembrolizumab26.0 (13.3 to 55.9)31.9 (9.2 to NA)
Other pre-specifiedCorrelation 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
Reported as:
Median · months
Correlation Between PD-L1 IHC Status and Progression-Free Survival in Patients Treated With Pembrolizumab
monthsPD-L1 NegativePD-L1 Positive
Correlation Between PD-L1 IHC Status and Progression-Free Survival in Patients Treated With Pembrolizumab3.9 (2.5 to 6.5)5.7 (3.4 to NA)
Other pre-specifiedTo 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

No measurements were reported for this outcome.

Other pre-specifiedOverall 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
Reported as:
Median · years
Overall Survival for IBC or Non-IBC TNBC Patients Treated With Pembrolizumab
yearsTreatment (Pembrolizumab)
Overall Survival for IBC or Non-IBC TNBC Patients Treated With Pembrolizumab2.17 (1.11 to 3.19)

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment (Pembrolizumab)34/45 (75.6%)13/45 (28.9%)40/45 (88.9%)
Most frequent serious events
Showing 10 of 19
Most frequent serious events
EventTreatment (Pembrolizumab)
Disease progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps)3/45
Adrenal insufficiencyEndocrine disorders2/45
HeadacheNervous system disorders2/45
HypothyroidismEndocrine disorders2/45
InfectionInfections and infestations2/45
Abdominal painGastrointestinal disorders1/45
ColitisGastrointestinal disorders1/45
ConstipationGastrointestinal disorders1/45
DehydrationMetabolism and nutrition disorders1/45
DiarrheaGastrointestinal disorders1/45
Most frequent other events
Showing 10 of 65
Most frequent other events
EventTreatment (Pembrolizumab)
NauseaGastrointestinal disorders20/45
HeadacheNervous system disorders19/45
FatigueGeneral disorders18/45
MyalgiaMusculoskeletal and connective tissue disorders16/45
CoughRespiratory, thoracic and mediastinal disorders15/45
Rash maculo-papularSkin and subcutaneous tissue disorders15/45
VomitingGastrointestinal disorders15/45
DiarrheaGastrointestinal disorders13/45
Nasal congestionRespiratory, thoracic and mediastinal disorders12/45
ConstipationGastrointestinal disorders11/45

Baseline characteristics

Age, Continuous
Age, Continuous(years)Treatment (Pembrolizumab)
Median54 (34 to 77)
Sex: Female, Male
Sex: Female, Male(Participants)Treatment (Pembrolizumab)
Female45
Male0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Treatment (Pembrolizumab)
Hispanic or Latino4
Not Hispanic or Latino38
Unknown or Not Reported3
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment (Pembrolizumab)
American Indian or Alaska Native1
Asian2
Native Hawaiian or Other Pacific Islander0
Black or African American0
White38
More than one race4
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Treatment (Pembrolizumab)
United States45
07

Study locations

1 site
  • M D Anderson Cancer Center
    Houston, Texas 77030, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 10, 2023

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT02411656
Lead sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Apr 8, 2015
Start date
Jun 11, 2015
Primary completion
Jun 15, 2024
Completion
Dec 31, 2028 (estimated)
Results posted
Jul 2, 2025
Last update
Jul 15, 2026

Study contacts

Bora Lim, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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