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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

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ClinicalTrials.gov Identifier: NCT02411656
Recruitment Status : Active, not recruiting
First Posted : April 8, 2015
Last Update Posted : January 25, 2023
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
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 Other: Laboratory Biomarker Analysis Biological: Pembrolizumab Phase 2

Detailed Description:


I. To assess the efficacy of pembrolizumab (MK-3475) as a single agent in patients with metastatic inflammatory breast cancer (IBC) and non-IBC triple-negative breast cancer (TNBC).


I. 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.

II. 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.

III. To investigate the association between biomarkers and efficacy by ribonucleic acid (RNA)-sequencing of exosomes in blood and tumor for IBC or non-IBC TNBC patients.


Patients receive pembrolizumab intravenously (IV) over approximately 30 minutes on day 1. Courses repeat every 21 days for 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Anti-PD-1 (MK-3475) Therapy in Patients With Metastatic Inflammatory Breast Cancer (IBC) or Non-IBC Triple Negative Breast Cancer (TNBC) Who Have Achieved Clinical Response or Stable Disease to Prior Chemotherapy
Actual Study Start Date : June 11, 2015
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Treatment (pembrolizumab)
Patients receive pembrolizumab IV over approximately 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Correlative studies

Biological: Pembrolizumab
Given IV
Other Names:
  • Keytruda
  • Lambrolizumab
  • MK-3475
  • SCH 900475

Primary Outcome Measures :
  1. Rate of disease control [ Time Frame: Up to 3 months post-treatment ]
    Defined as the percentage of patients either with measurable disease that maintain immune complete response (iCR), immune partial response, immune stable disease (iSD), or with non-measurable disease that achieve iCR or iSD, by 4 months or more in all evaluable patients. A disease control rate of 10% or lower will be considered treatment failure and the regimen will be rejected under this circumstance. A 95% exact binomial confidence interval on disease control rate will be computed. Will also perform secondary analysis on intent-to-treat patient population where those patients who drop out early will be considered as progression.

Secondary Outcome Measures :
  1. Biomarker analyses [ Time Frame: Baseline ]
    Correlation among biomarkers at baseline in each specimen and between different specimens will be assessed. The association among various continuous and discrete biomarkers or disease status groups will be assessed by the exploratory data analysis using scatter plot matrix, box plots, BLiP plot and trellis plot, etc, and may be tested by t-test/analysis of variance/Wilcoxon rank sun test/Kruskal-Wallis test, whichever is appropriate. Correlation between continuous biomarkers will be examined by Pearson or Spearman rank correlation coefficients.

  2. Disease control survival [ Time Frame: Up to 3 months post-treatment ]
    Estimated using Kaplan-Meier method.

  3. Overall survival time [ Time Frame: Up to 3 months post-treatment ]
    Estimated using Kaplan-Meier method.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Is willing and able to provide written informed consent for the trial
  • 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 Response Evaluation Criteria in Solid Tumors (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 immunohistochemistry (IHC) and negative by fluorescence in situ hybridization (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
  • Absolute neutrophil count (ANC) >= 1,500/mcL
  • Platelets >= 100,000 /mcL
  • Hemoglobin (Hgb) >= 9 g/dL
  • Creatinine levels < 1.5 x upper limit of normal (ULN)
  • Total bilirubin =< 1.5 x ULN
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN or =< 5 x ULN for subjects with liver metastases
  • Subjects 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; subjects 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:

    • 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)
    • Intrauterine devices (IUDs)
    • 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 subjects of childbearing potential

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: subjects 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; subjects 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; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects 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 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) within 3 months
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02411656

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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Bora Lim M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02411656    
Other Study ID Numbers: 2014-0533
NCI-2015-00671 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2014-0533 ( Other Identifier: M D Anderson Cancer Center )
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: January 25, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Inflammatory Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases
Skin Manifestations
Antineoplastic Agents, Immunological
Antineoplastic Agents