Clinical Trials /

A Study of Pembrolizumab With Carboplatin and Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer

NCT02755272

Description:

The main purpose of this study is to see if Pembrolizumab in combination with chemotherapy (carboplatin and gemcitabine) is safe and effective in treating patients with metastatic triple negative breast cancer. Pembrolizumab is a drug which may help the immune system to target and destroy cancer cells. Pembrolizumab has been approved by the FDA for the treatment of advanced melanoma and metastatic non-small cell lung cancer. However, it has not been approved as a treatment for breast cancer.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

A Study of <span class="go-doc-concept go-doc-intervention">Pembrolizumab</span> With <span class="go-doc-concept go-doc-intervention">Carboplatin</span> and <span class="go-doc-concept go-doc-intervention">Gemcitabine</span> in Patients With Metastatic <span class="go-doc-concept go-doc-keyword">Triple Negative</span> Breast Cancer

Title

  • Brief Title: A Study of Pembrolizumab With Carboplatin and Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer
  • Official Title: A Randomized Phase II Clinical Trial Assessing the Efficacy and Safety of MK-3475 (Pembrolizumab) in Combination With Carboplatin and Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer
  • Clinical Trial IDs

    NCT ID: NCT02755272

    ORG ID: BR-076

    Trial Conditions

    Carcinoma Breast Stage IV

    Trial Interventions

    Drug Synonyms Arms
    Pembrolizumab MK-3475, Keytruda Pembrolizumab with Standard Chemotherapy
    Carboplatin Paraplatin Pembrolizumab with Standard Chemotherapy, Standard Chemotherapy Alone
    Gemcitabine Gemzar Pembrolizumab with Standard Chemotherapy, Standard Chemotherapy Alone

    Trial Purpose

    The main purpose of this study is to see if Pembrolizumab in combination with chemotherapy
    (carboplatin and gemcitabine) is safe and effective in treating patients with metastatic
    triple negative breast cancer.

    Pembrolizumab is a drug which may help the immune system to target and destroy cancer cells.
    Pembrolizumab has been approved by the FDA for the treatment of advanced melanoma and
    metastatic non-small cell lung cancer. However, it has not been approved as a treatment for
    breast cancer.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Pembrolizumab with Standard Chemotherapy Experimental Pembrolizumab plus standard chemotherapy using carboplatin and gemcitabine. Pembrolizumab, Carboplatin, Gemcitabine
    Standard Chemotherapy Alone Active Comparator Standard chemotherapy alone using carboplatin and gemcitabine. Carboplatin, Gemcitabine

    Eligibility Criteria

    Inclusion Criteria:

    - Women diagnosed with pathologically confirmed metastatic triple negative invasive
    breast cancer (centrally confirmed immunophenotype negative for all three receptors
    ER, PR and HER2).

    - Have either evaluable disease, or have measurable clinical disease: Measurable
    disease, defined as at least 1 unidimensionally measurable lesion on a CT scan as
    defined by RECIST (version v1.1).

    - Patients received up to 2 prior regimens for their disease in the metastatic setting.

    - Patients are candidates for chemotherapy with carboplatin and gemcitabine.

    - Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.

    - Patients must be willing and able to provide written informed consent for the trial

    - Demonstrate adequate organ function as defined below, all screening labs should be
    performed within 10 days of treatment initiation.

    - Absolute neutrophil count (ANC) Greater than or equal to 1,500 /mcL.

    - Platelets greater than or equal to 100,000 / mcL.

    - Hemoglobin greater than or equal to 9 g/dL or 5.6 mmol/L.

    - Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be
    used in place of creatinine or CrCl) less than or equal to 1.5 X upper limit of
    normal (ULN) OR greater than or equal to 60 mL/min for subject with creatinine
    levels greater than 1.5 X institutional ULN.

    - Serum total bilirubin less than 1.5 X ULN OR Direct bilirubin less than the ULN
    for subjects with total bilirubin levels greater than 1.5 ULN.

    - Aspartate aminotransferase (AST) (SGOT) and Alanine aminotransferase (ALT)
    (SGPT) less than or equal to 2.5 X ULN OR less than or equal to 5 X ULN for
    subjects with liver metastases.

    - International Normalized Ratio (INR) or Prothrombin Time (PT) less than or equal
    to 1.5 X ULN unless subject is receiving anticoagulant therapy.

    - Activated Partial Thromboplastin Time (aPTT) less than or equal to 1.5 X ULN
    unless subject is receiving anticoagulant therapy as long as PT or PTT is within
    therapeutic range of intended use of anticoagulants.

    - Patients of childbearing potential must be willing to use 2 methods of birth control
    or be surgically sterile, or abstain from heterosexual activity for the course of the
    study through 120 days after the last dose of study medication.

    Exclusion Criteria:

    - Patients participating in another trial of an investigational agent within 4 weeks of
    the first dose of the study.

    - Patients who received prior therapy using carboplatin/gemcitabine less than 12 months
    from the beginning of their enrollment or subjects whose tumor progressed while on
    treatment with carboplatin or cisplatin.

    - Patients with baseline grade 2 neuropathy.

    - Diagnosis of immunosuppression or receiving steroid therapy or other
    immunosuppressive therapy within 4 weeks of the study.

    - Active autoimmune disease or a documented history of autoimmune disease, or a
    syndrome that has required systemic treatment in the past 2 years

    - Has evidence of interstitial lung disease or active, non-infectious pneumonitis

    - Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has
    not recovered (i.e., Grade 1 or at baseline) from adverse events due to agents
    administered more than 4 weeks earlier.

    - Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy
    within 2 weeks prior to study Day 1 or who has not recovered (i.e., Grade 1 or at
    baseline) from adverse events due to a previously administered agent.

    - If subject received major surgery, they must have recovered adequately from the
    toxicity and/or complications from the intervention prior to starting therapy.

    - Known additional malignancy that progressed and/or required treatment in the last 5
    years. Except that for basal and squamous cell carcinoma of the skin or in situ
    cervical carcinoma that has completed potentially curative therapy.

    - Life expectancy of less than 3 months.

    - Prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death
    1 ligand (PDL-1), anti-PD-L2, anti-CD137 antibody, or anti-cytotoxic T-lymphocyte
    -associated antigen-4 (CTLA-4) antibody.

    - Pregnant, breastfeeding, or expecting to conceive children within the projected time
    of the trial, starting with the pre-screening or screening visit and through 120 days
    after the last dose of trial treatment.

    - Active infection requiring systemic therapy.

    - Has known active central nervous system (CNS) metastases and/or carcinomatous
    meningitis. Subjects with previously treated brain metastases may participate
    provided they are stable (without evidence of progression by imaging for at least
    four weeks prior to the first dose of trial treatment and any neurologic symptoms
    have returned to baseline), have no evidence of new or enlarging brain metastases,
    and are not using steroids for at least 7 days prior to trial treatment.

    - Has a history or current evidence of any condition, therapy, or laboratory
    abnormality that might confound the results of the trial, interfere with the
    subject's participation for the full duration of the trial, or is not in the best
    interest of the subject to participate, in the opinion of the treating investigator.

    - Has received a live vaccine within 30 days prior to the first dose of trial
    treatment.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Female

    Primary Outcome Measures

    Objective Response Rate

    Incidence of Treatment-Related Adverse Events

    Secondary Outcome Measures

    Clinical Benefit Rate

    Progression Free Survival

    Overall Survival

    Trial Keywords

    Triple Negative Breast Cancer