Clinical trial NCT02413320 (phase 2, status: completed)
Conditions: triple-negative breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: paclitaxel, carboplatin, doxorubicin, cyclophosphamide, docetaxel
SMILES: [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC, N[C@@H](CCCNC(N)=N)C(O)=O, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O, ClCCN(CCCl)P1(=O)NCCCO1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
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