Neoadjuvant Treatment of Triple Negative Breast Cancer Patients With Docetaxel and Carboplatin to Assess Anti-tumor Activity
Condition: Triple Negative Breast Neoplasms
MeSH terms: Triple Negative Breast Neoplasms; Breast Neoplasms
Intervention: Docetaxel; Carboplatin; FDG-PET/MR
Intervention description: Prior to initialization of Cycle 1 and completion of cycle 1 (preferably on cycle 2 day 1)
This is not optional for final 30 participants enrolled on the study
Intervention MeSH terms: Carboplatin; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 148.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a single arm open label phase II study in women with clinical stage 2 or 3 triple
      negative breast cancer to assess the anti-tumor activity (in terms of pathologic complete
      response rate) of neoadjuvant docetaxel in combination with carboplatin. Patient derived
      xenografts will also be developed simultaneously for the purposes of genoproteomic analysis.

      Please note that Baylor College of Medicine (BCM) has a parallel study the same as this
      study. Baylor is expected to enroll approximately 19 participants that have complied with the
      inclusion and exclusion criteria for this study (excluded participants from BCM will include
      male participants or participants with inflammatory breast cancer). The investigators will
      pool participants and data from the BCM study and the study at Washington University School
      of Medicine. Pooling the data will potentially improve statistical power.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed AJCC7 clinical stage II or III breast cancer with complete surgical
             excision of the breast cancer after neoadjuvant chemotherapy as the treatment goal.

          -  Patients with PR+ tumors are allowed.

          -  HER2 negative by FISH or IHC staining 0 or 1+.

          -  ER less than Allred score of 3 or less than 1% positive staining cells in the invasive
             component of the tumor

          -  Tumor size at least 2cm in one dimension by clinical or radiographic exam (WHO
             criteria). Patients with palpable lymph nodes may be enrolled regardless of tumor
             size.

          -  At least 18 years of age.

          -  ECOG performance status ≤ 2

          -  Normal bone marrow and organ function as defined below:

               -  Leukocytes ≥ 3,000/mcL

               -  Absolute neutrophil count ≥ 1,500/mcl

               -  Platelets ≥ 100,000/mcl

               -  Serum bilirubin within (or under ) normal limits (OR total bilirubin ≤ 3.0 x IULN
                  with direct bilirubin within normal range in patients with well documented
                  Gilbert Syndrome)

               -  AST(SGOT)/ALT(SGPT) within (or under ) normal limits

               -  Creatinine clearance ≥ 60 mL/min/1.73 m2

          -  Patients may be pre- or post-menopausal. Women of childbearing potential must agree to
             use adequate contraception (hormonal or barrier method of birth control, abstinence)
             prior to study entry and for the duration of study participation. Should a woman
             become pregnant or suspect she is pregnant while participating in this study, she must
             inform her treating physician immediately.

          -  Ability to understand and willingness to sign an IRB approved written informed consent
             document (or that of legally authorized representative, if applicable).

          -  Able to tolerate PET/MRI with intravenous contrast administration and must complete
             the applicable MRI screening evaluation form

        Exclusion Criteria:

          -  Prior systemic therapy for the indexed breast cancer.

          -  A history of other malignancy ≤ 5 years previous with the exception of basal cell or
             squamous cell carcinoma of the skin which were treated with local resection only or
             carcinoma in situ of the cervix.

          -  Patients with bilateral or inflammatory breast cancer.

          -  Currently receiving any other investigational agents.

          -  A history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to docetaxel or carboplatin.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.

          -  Pregnant and/or breastfeeding. Patient must have a negative serum pregnancy test
             within 7 days of study entry if premenopausal.

          -  Known HIV-positivity.

          -  Sentinel lymph node biopsy

          -  Renal insufficiency (glomerular filtration rate (GFR) < 30 mL/min/1.73 m2) measured
             within the past 60 days which precludes safe administration of the contrast agent

          -  On dialysis

          -  Prior allergic reaction to gadolinium-based MR contrast agents