Chemokine Modulation Therapy and Standard Chemotherapy Before Surgery for the Treatment of Early Stage Triple Negative Breast Cancer
Condition: Anatomic Stage 0 Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Early-Stage Breast Carcinoma; Estrogen Receptor Negative; HER2/Neu Negative; Progesterone Receptor Negative; Prognostic Stage 0 Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Triple-Negative Breast Carcinoma
MeSH terms: Carcinoma; Breast Neoplasms; Triple Negative Breast Neoplasms; Breast Carcinoma In Situ
Intervention: Celecoxib; Cyclophosphamide; Doxorubicin; Doxorubicin Hydrochloride; Paclitaxel; Recombinant Interferon Alfa-2b; Rintatolimod
Intervention description: Given PO; Given IV; Given IV; Given IV; Given IV; Given IV; Given IV
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; poly(I).poly(c12,U); Celecoxib; Paclitaxel; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Albumin-Bound Paclitaxel; Daunorubicin; Benzenesulfonamide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase I trial studies how well chemokine modulation therapy and standard chemotherapy
      given before surgery work in treating patients with early stage triple negative breast
      cancer. Chemokine modulation therapy, including celecoxib, recombinant interferon alfa-2b,
      and rintatolimod, may stimulate the immune system and stop tumor cells from growing. Drugs
      used in standard chemotherapy, such as paclitaxel, doxorubicin, and cyclophosphamide, work in
      different ways to stop the growth of tumor cells, either by killing the cells, by stopping
      them from dividing, or by stopping them from spreading. Giving chemokine modulation therapy
      together with standard chemotherapy may work better than giving either therapy alone in
      treating patients with triple negative breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have pathologically confirmed diagnosis of resectable triple negative breast cancer
             (ASCO/CAP guidelines will be used to define triple negative breast cancer)

          -  Must have measurable disease. Multi-centric disease is allowed. If patient has another
             lesion which is biopsied with ER/PR positive it will be Physician discretion for this
             eligibility criteria.

          -  Prior therapy: No prior cytotoxic regimens are allowed for this malignancy.
             Participants may not have had prior chemotherapy, other targeted anticancer therapies,
             or prior radiation therapy to the ipsilateral breast for this malignancy. Prior
             bis-phosphonate therapy is allowed

          -  Patient eligible for surgery as determined by patient's surgeon

          -  Patient must have a lesion that amendable to biopsy, unless inaccessible and with PI
             approval

          -  Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

          -  Participants of child-bearing potential must agree to use adequate contraceptive
             methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study
             entry. Should a woman become pregnant or suspect she is pregnant while she or her
             partner is participating in this study, she should inform her treating physician
             immediately

          -  Ability to swallow and retain oral medication

          -  Ability to undergo magnetic resonance imaging (MRI)

          -  Platelets >= 100,000/uL

          -  Hemoglobin >= 9 g/dL

          -  Absolute neutrophil count (ANC) >= 1500/uL

          -  Total bilirubin =< institutional upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and
             ALT (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 X institutional upper limit
             of normal (ULN)

          -  Creatinine < ULN OR creatinine clearance >= 50 mL/min per Cockcroft-Gault equation for
             patients with creatinine levels greater than ULN

          -  Left ventricular ejection fraction (LVEF) >= 55%; if LVEF is < 55% and patient is
             otherwise study-eligible, the principal investigator (PI) will discuss with
             cardiologist if patient is eligible to receive doxorubicin and participate in study

          -  Participant or legal representative must understand the investigational nature of this
             study and sign an Independent Ethics Committee/Institutional Review Board approved
             written informed consent form prior to receiving any study related procedure

          -  Participants on this study will be counseled on and are willing to use adequate
             contraceptive methods

        Exclusion Criteria:

          -  Patients currently treated with systemic immunosuppressive agents, including steroids,
             are ineligible until 3 weeks after removal from immunosuppressive treatment

          -  Patients with active autoimmune disease, requiring ongoing immunosuppressive therapy
             or history of transplantation

          -  Diagnosis of invasive carcinoma within the last 3 years

          -  Inflammatory breast cancer will be excluded from the study

          -  Participants who have metallic surgical implants that are not compatible with an MRI
             machine are not eligible

          -  Pregnant or nursing female participants

          -  Unwilling or unable to follow protocol requirements

          -  Patients with known serious mood disorders. (Major depression is an exclusion. Other
             stable mood disorders on stable therapy for > 6 months may be allowed after
             consultation with PI)

          -  Cardiac risk factors including:

               -  Patients experiencing cardiac event(s) (acute coronary syndrome, myocardial
                  infarction, or ischemia) within 3 months of signing consent

               -  Patients with a New York Heart Association classification of III or IV

          -  History of upper gastrointestinal ulceration, upper gastrointestinal bleeding, or
             upper gastrointestinal perforation within the past 3 years

          -  Prior allergic reaction or hypersensitivity to nonsteroidal anti-inflammatory drugs
             (NSAIDs) or any drugs administered on protocol

          -  Any history of allergy to sulfonamides

          -  Any history of autoimmune hepatitis

          -  Grade 1 or higher neuropathy

          -  Any condition which in the investigator's opinion deems the participant an unsuitable
             candidate to receive study drug