Trial 1B-10-3

Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2.

Type: Cancer Therapy
Phase: Phase II/III
Status: Open to Accrual
Treatments: Chemotherapy: Systemic
Randomized: Yes
Defintions of terms and FAQ about clinical trials.

Trial Leaders/Researchers: Debasish Tripathy, M.D.
Other Trial Staff: Kristy Watkins, R.N., Nancy Perez, R.N., Yvonne Flores, D.M., Margarita Carranza, D.M.

Staff may log in to see study documents.

You may participate in this study if:

	Requirement
1	Histologically confirmed invasive cancer of the breast
2	Clinically or radiologically measureable disease in the breast after diagnostic biopsy, defined as longest diameter greater than or equal to 25 mm (2.5cm)
3	No prior cytotoxic regimens are allowed for this malignancy. Patients may not have had prior chemotherapy or prior radiation therapy to the ipsilateral breast for this malignancy. Prior bis-phosphonate therapy is allowed
4	Age greater than or equal to18 years
5	ECOG performance status 0-1
6	Willing to undergo core biopsy of the primary breast lesion to assess baseline biomarkers
7	Non-pregnant and non-lactating
8	No ferromagnetic prostheses. Patients who have metallic surgical implants that are not compatible with an MRI machine are not eligible.
9	Ability to understand and willingness to sign a written informed consent (I-SPY TRIAL Screening Consent)
10	Eligible tumors must meet one of the following criteria: Stage II or III, or T4, any N, M0, including clinical or pathologic inflammatory cancer or Regional Stage IV, where supraclavicular lymph nodes are the only sites metastasis
11	Any tumor ER/PgR status, any HER-2/neu status as measured by local hospital pathology laboratory and meets any tumor assay profile described in protocol section 4.1.2F
12	Normal organ and marrow function: Leukocytes greater than or equal to 3000/µL, Absolute neutrophil count greater than or equal to 1500/µL, Platelets greater than or equal to 100,000/µL, Total bilirubin within normal institutional limits, unless patient has Gilbert's disease, for which bilirubin must be less than or equal to 2.0 x ULN, AST(SGOT)/ALT (SGPT) less than or equal to 1.5 x institutional ULN, creatinine less than 1.5 x institutional ULN
13	No uncontrolled or severe cardiac disease [history of diagnosis of unstable angina, myocardial infarction, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia (including atrial flutter/fibrillation), requirement for inotropic support or use of devices for cardiac conditions (pacemakers/defibrillators)]. Baseline ejection fraction (by nuclear imaging or echocardiography) must be greater than or equal to 50%
14	No clinical or imaging evidence of distant metastases by PA and Lateral CXR, Radionuclide Bone scan, and LFTs including total bilirubin, ALT, AST, and alkaline phosphatase
15	Tumor assay profile must include on of the following: MammaPrint High, any ER status, any HER2 status, or MammaPrint Low, ER negative (<5%), any HER2 status, or MammaPrint Low, ER positive, HER2/neu positive by any one of the three methods used (IHC, FISH, TargetPrint™)
16	Ability to understand and willingness to sign a written informed consent document (I-SPY 2 TRIAL Consent #2)

You may not participate in this study if:

1	Use of any other investigational agents within 30 days of starting study treatment
2	History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent or accompanying supportive medications.
3	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
4	Sentinel lymph node dissection on the nodes draining from the study index tumor site is not allowable prior to the start of chemotherapy. Any patient who has undergone sentinel lymph node dissection on the side of the study index tumor prior to start of chemotherapy is not eligible.

For further information on a study, please contact the Clinical Investigation Support Office at (323) 865-0451, or clinical.trials@med.usc.edu.

To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.