Houston, Texas 77030


Purpose:

This phase II trial studies how well pembrolizumab works in treating patients with hormone receptor positive inflammatory breast cancer that has not spread to other parts of the body, who are receiving hormone therapy and did not achieve a pathological complete response to 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.


Study summary:

PRIMARY OBJECTIVES: I. To determine the disease free survival (DFS) at 2 years of patients with maintenance therapy using pembrolizumab in combination with standard adjuvant hormonal therapy. II. To determine the safety and toxicity profile of primary inflammatory breast cancer (IBC) patients who received combination of pembrolizumab and hormone receptor blockade. EXPLORATORY OBJECTIVES: I. To investigate the association between immune related biomarkers in the peripheral blood and tumor tissue, such as PD-L1 expression, with safety and efficacy for IBC patients treated with pembrolizumab. OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Cycles 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 1 and 24 months.


Criteria:

Inclusion Criteria: - Is willing and able to provide written informed consent for the trial. - Has histological confirmation of breast carcinoma. - Has confirmed inflammatory breast cancer by using international consensus criteria: - Onset: Rapid onset of breast erythema, edema and/or peau d'orange, and/or warm breast, with/without an underlying breast mass. - Duration: History of such findings no more than 6 months. - Extent: Erythema occupying at least 1/3 of whole breast. - Pathology: Pathologic confirmation of invasive carcinoma. - Did not achieve pathological complete response (pCR) to any chemotherapy that was given with the intention to induce best response prior surgery. pCR is defined as the current American Joint Committee on Cancer (AJCC) breast cancer staging. - 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 positive estrogen receptor (ER) or progesterone receptor (PR) status. ER or PR >= 10%. - 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. - Subjects of reproductive potential must agree to avoid becoming pregnant or impregnating a partner, respectively, while receiving study drug and for 120 days after the last dose of study drug by complying with one of the following: (1) practice abstinence from heterosexual activity; OR (2) use (or have their partner use) acceptable contraception during heterosexual activity. - Has negative serum or urine pregnancy test for subjects of childbearing potential within 10 days before first dose. - Have completed radiation (if candidate for post-mastectomy radiation) or plans to begin radiation and endocrine therapy within 28 days. - If patient has already started hormonal blockade therapy after radiation as adjuvant therapy, the patient is eligible as long as the hormonal therapy was initiated no more than 6 months by the time of screening and can start the study drug within 4 weeks since the completion of screening. Exclusion Criteria: - Is currently participating in a study of an investigational anti-cancer agent. - Has a diagnosis of immunodeficiency 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 history of prior malignancy with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cervical cancer, and has undergone potentially curative therapy and has no evidence of recurrence over the last 1 year since completion of curative therapy. - Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, 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, inhaled steroid or local steroid injections to the skin 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 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. - Gastrointestinal tract disease or defect or previous history of colitis. - Has proven or suspected distant metastasis that involves occurrence of breast cancer outside of locoregional breast and lymph nodes area. - Subjects requiring daily corticosteroids either via oral route of administration (po) or infusion. - Myocardial infarction within 6 months before starting therapy, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or unstable cardiac arrhythmia requiring medication.


NCT ID:

NCT02971748


Primary Contact:

Principal Investigator
Bora Lim
M.D. Anderson Cancer Center

Bora Lim, MD
Phone: 713-792-2817
Email: blim@mdanderson.org


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

Bora Lim
Phone: 713-792-2817

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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