Statement: Patients with HER2 negative tumours are eligible for the primary trial but not for the secondary trial
Primary_evidence: Inclusion Criteria:   Inoperable estrogen receptor positive and HER2 negative breast cancer.   Postmenopausal status.   Tumor tissue (archived acceptable) available for biomarker studies. For Phase 2 Part 2 - CCND1 amplification and/or loss of p16 as determined by the central laboratory.   Acceptable bone marrow, liver and kidney function. Exclusion Criteria:   Prior or concomitant treatment for advanced breast cancer.   Other major cancer in the past 3 years.   Important cardiovascular events in the past 6 months.
Secondary_evidence: 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