Neoadjuvant Study of Two Platinum Regimens in Triple Negative Breast Cancer
Condition: Triple-negative Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Intervention: Paclitaxel; Carboplatin; Doxorubicin; Cyclophosphamide; Docetaxel
Intervention MeSH terms: Paclitaxel; Docetaxel; Cyclophosphamide; Carboplatin; Doxorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: TNBC, breast cancer, neoadjuvant, carboplatin, docetaxel, paclitaxel, doxorubicin, cyclophosphamide

Summary:

      Evaluate if the two carboplatin containing chemotherapy regimens will reduce the growth of
      breast cancer cells in women with Stage I, II, or III triple negative breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with newly diagnosed stage I (T>1cm), II or III triple negative breast cancer
             who have not had definitive breast surgery or received systemic chemotherapy

          -  The invasive tumor must be hormone receptor-poor, defined as both estrogen receptor
             and progesterone receptor staining present in ≤ 10% of invasive cancer cells by
             Immunohistochemistry.

          -  HER- 2 negativity will be based on the current ASCO-CAP guidelines for HER testing

          -  No prior chemotherapy, endocrine therapy or radiation therapy with therapeutic intent
             for this cancer

          -  Female subjects age 18 - 70 years

          -  ECOG Performance Status of 0-1

          -  Adequate organ and marrow function as defined below:

               -  Leukocytes ≥ 3,000/uL

               -  Absolute neutrophil count ≥ 1500/uL

               -  Platelets ≥ 100,000/uL

               -  Total bilirubin ≤ 1.5mg/dL

               -  AST(SGOT)/ALT(SPGT) ≤ 2 x institutional upper limit of normal

               -  Creatinine ≤ 1.5mg/dl and/or Creatinine Clearance ≥ 60mL/min

               -  Serum albumin ≥ 3.0 g/dL

          -  Women of child-bearing potential must agree to use adequate contraception

          -  Pretreatment lab values must be performed within 14 days of treatment initiation, and
             other baseline studies performed within 30 days prior to registration

          -  Subjects should have LVEF ≥ 50% by echocardiogram or MUGA scan performed within 4
             weeks prior to treatment initiation

          -  Subjects should have breast and axillary imaging with breast MRI or breast and
             axillary ultrasound within 4 weeks prior to treatment initiation

          -  Subjects with clinically/radiologically abnormal axillary lymph nodes should have
             pathological confirmation of disease with image guided biopsy/fine needle aspiration.

          -  Subjects must be already enrolled in P.R.O.G.E.C.T observational registry

          -  Staging to rule out metastatic disease is recommended for subjects with clinical stage
             III disease

          -  Subjects with bilateral disease are eligible if they meet other eligibility criteria.

          -  Neuropathy: No baseline neuropathy grade > 2

        Exclusion Criteria:

          -  Current or anticipated use of other investigational agents

          -  Subject has received chemotherapy, radiotherapy or surgery for the treatment of breast
             cancer

          -  Subject with metastatic disease

          -  History of allergic reactions to compounds of similar chemical or biologic composition
             to carboplatin, docetaxel, doxorubicin, cyclophosphamide, paclitaxel, or other agents
             used in the study

          -  Subjects with inflammatory breast cancer

          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active
             infection or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Subject is pregnant or nursing

          -  Subjects with concomitant or previous malignancies within the last 5 years. Exceptions
             include: adequately treated basal or squamous cell carcinoma of the skin, carcinoma in
             situ of the cervix, and ductal carcinoma in situ (DCIS).

          -  Ejection Fraction <50% on ECHO or MUGA

          -  Cardiac function: Subjects with congestive heart failure, myocardial infarction,
             unstable angina pectoris, an arterial thrombotic event, stroke or transient ischemia
             attack within the past 12 months, uncontrolled hypertension (Systolic BP>160 or
             Diastolic BP>90), uncontrolled or symptomatic arrhythmia, or grade ≥ 2 peripheral
             vascular disease