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Carboplatin with or without Pembrolizumab in Treating Patients with Advanced Breast Cancer with Locally Recurrent Chest Wall Disease That Cannot Be Removed by Surgery

This randomized phase II trial studies how well carboplatin with or without pembrolizumab work in treating patients with breast cancer that has spread to other places in the body (advanced) with chest wall disease that has come back (locally recurrent) and cannot be removed by surgery. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. 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.
Breast
Phase II
Adults
Chemotherapy - cytotoxic, Hormonal Therapy, Mol. targeted/Immunotherapy/Biologics
Carboplatin, MK-3475, Pembrolizumab (MK-3475), Trastuzumab (Herceptin)
Abramson, Vandana
National
Vanderbilt University
05-14-2018
Treatment
VICCBRE1808
NCT03095352

Eligibility

18 Years
BOTH
NO
Inclusion Criteria:

Advanced breast cancer with locally recurrent chest wall disease not amenable to surgical excision * Distant sites of disease are allowed * Prior radiation to the chest wall is not required

The following disease subtypes are eligible: * Triple negative disease (defined as estrogen receptor [ER] = 50% using electrocardiography (ECHO) or multigated acquisition scan (MUGA)

Any number of prior lines of therapy are allowed * Prior platinum based therapy is allowed in the following settings: ** Treatment in the neoadjuvant and/or adjuvant setting without clear progression of disease ** Treatment in the metastatic setting without clear progression of disease

At least two weeks from last systemic chemotherapy for breast cancer, with recovery of all treatment related toxicity to grade 1 or less; subjects with =
At least two weeks from last radiation therapy, with recovery of all treatment related toxicity to grade 1 or less (excluding alopecia)

Prior central nervous system (CNS) disease is allowed if stable for at least one month since whole brain radiation therapy, and 2 weeks since stereotactic radiotherapy, and not requiring steroids; patients whose CNS disease was surgically treated may be enrolled if stable for at least one month, and not requiring steroids

Able to provide tissue from a newly obtained core or excisional biopsy of a chest wall tumor lesion; newly-obtained is defined as a specimen any time after the last systemic or local therapy utilized to treat the disease; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the study chair

Willing and able to provide written informed consent

Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2

Absolute neutrophil count (ANC) >= 1,000 /mcL (within 10 days of treatment initiation)

Platelets >= 100,000/mcL (within 10 days of treatment initiation)

Hemoglobin >= 9 g/dL or >= 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment) (within 10 days of treatment initiation)

Serum creatinine == 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN (within 10 days of treatment initiation) * Creatinine clearance should be calculated per institutional standard

Serum total bilirubin = 1.5 ULN (within 10 days of treatment initiation)

Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =
Albumin >= 2.5 g/dL (within 10 days of treatment initiation)

International normalized ratio (INR) or prothrombin time (PT) =
Activated partial thromboplastin time (aPTT) =
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

Female subjects of childbearing potential should be willing to use an acceptable form 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; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year

Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy



Exclusion Criteria:

Treatment with an investigational agent within 4 weeks of the first dose of treatment

A diagnosis of immunodeficiency or is currently receiving systemic steroid therapy at any dose or is receiving any other form of immunosuppressive therapy; steroid therapy is not allowed within 7 days prior to the first dose of trial treatment; however, topical and intranasal corticosteroids are allowed, and not an exclusion for participation

Known active TB (Bacillus tuberculosis); patients with a distant history of tuberculosis that was appropriately treated and have no evidence of active infection are eligible to participate; patients with a history of latent tuberculosis that was appropriately treated are also eligible to participate

Hypersensitivity to pembrolizumab or any of its excipients

Hypersensitivity to carboplatin or cisplatin

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., =
Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer

Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis

Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment

Has active pneumonitis requiring treatment with steroids or active interstitial lung disease

Has an active infection requiring systemic therapy

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 known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, screening visit through 120 days after the last dose of trial treatment

Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent; has been on any prior Merck MK-3475 (pembrolizumab) studies

Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)

Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)

Has received a live vaccine within 30 days of planned start of study therapy; Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed

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