Orange, California 92868


Purpose:

The purpose of this phase II is to study the efficacy and toxicity of carboplatin and paclitaxel with pertuzumab and trastuzumab in HER2 positive and carboplatin and paclitaxel with bevacizumab in HER2 negative in the neoadjuvant setting for the treatment of breast cancer.


Study summary:

OBJECTIVES There are two study components, 1) to evaluate the treatment response and toxicity of the protocol, and 2) to investigate the role of Magnetic Resonance Imaging (MRI) to monitor and predict the final pathological response. Objectives for treatment study component: 1.1 To estimate 2-year progression-free survival in patients with breast cancer with tumor more than 1 cm and/or with clinically detected lymph node treated with neoadjuvant weekly Carboplatin and Paclitaxel combined with Trastuzumab + Pertuzumab in HER2-positive disease or with Bevacizumab in HER2-negative disease. 1.2 To measure the microscopic complete pathological response (pCR) rates defined as ypT0 or Ductal carcinoma in situ (DCis) tumors in patients treated with this regimen in the neoadjuvant setting. 1.3 To assess complete clinical response (cCR) rates after treatment by physical exam and imaging tests (ultrasonography, mammography, or magnetic resonance imaging) clinical objective response rate (by Response Evaluation Criteria In Solid Tumors (RECIST)) 1.4 To determine the toxicity of this regimen. 1.5 To determine treatment adherence and delivered dose intensity of this regimen. 1.6 To assess the correlation between pCR and cCR. 1.7 To determine the rate of breast conservation following neoadjuvant therapy. 1.8 Determine treatment efficacy according to subgroups defined according to stage and receptor status. Objectives for MRI response monitoring study component: 1.9 Develop quantitative analysis methods to obtain pre-treatment tumor characteristics in breast cancer (including morphological and enhancement kinetic parameters) and select an optimal set of features using the logistic regression analysis and the Artificial Neural Network (ANN) to predict pathologic complete remission (pCR) in HER2-positive and negative arms. 1.10 Investigate whether the early response patterns in tumor (changes in percent tumor size or other tumor characteristic parameters) can be used to predict pathologic complete remission (pCR) in HER2 positive and negative arms. 1.11 Investigate whether combining the pre-treatment characteristic parameters and the early response patterns can achieve a higher AUC (area under the Receiver Operating Characteristic (ROC) curve) in prediction of pCR than those based on pre-treatment MRI characteristics or tumor response patterns alone.


Criteria:

Inclusion Criteria: - Histologically proven unilateral or bilateral primary breast carcinoma. (In case of bilateral cancer, the investigator has to decide prospectively which side will be evaluated for the primary endpoint.) - Tumor size is clinically at least 1 cm in greatest diameter (palpable or by imaging) and/or with involved lymph node. In case of inflammatory disease, the extent of inflammation may be the measurable lesion. - Documentation of inflammatory breast cancer Inflammatory breast cancer? - Woman age > or = 18 - Performance status of 0-2 by Eastern Cooperative Oncology Group (ECOG) criteria - Known HER2 status - Normal cardiac function must be documented within 90 days prior to registration. Result of ejection fraction must be above the normal limit of the institution. - Date of Echo or multigated acquisition (MUGA) (within 90 days) - Staging work-up prior to registration - Date of physical examination (within 90 days) - Date of bilateral mammogram (within 90 days) - Date of breast ultrasound (within 30 days) - Date of MRI breast (within 30 days) - Chest X-ray (within 90 days) - Other tests as clinically indicated - Laboratory requirements: - Hematology: - Absolute Neutrophil Count (ANC) ≥ 1,500/μl - Platelets ≥ 100,000/μl - Hepatic Function - Total Bilirubin <1x upper limit of normal (ULN) - aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2x ULN - Renal Function - Creatinine <1.5x ULN - Proteinuria - Urine dipstick for proteinuria <2+. Patients discovered to have ≥2+ proteinuria on dipstick should undergo a 24-hour urine collection and demonstrate ≤ 1g of protein in 24 hours. - Negative pregnancy test for women of childbearing potential within 14 days prior to registration. - All patients must be informed of the investigational nature of this study and must sign and\give written informed consent in accordance with institutional and federal guidelines. Exclusion Criteria: - Evidence of distant metastasis - Known or suspected congestive heart failure, angina pectoris requiring antianginal medication, or other clinically significant cardiac condition. - Pregnant or nursing women may not participate due to the possibility of harm to fetus or nursing infants from this treatment regimen. Women of childbearing potential may not participate unless they have agreed to use an adequate contraceptive method throughout study treatment and for one month after completion of treatment. - Male patients - Pre-existing peripheral neuropathy of severity grade ≥ 2 (limiting instrumental activities of daily living). - Incomplete wound healing. - Active and significant bleeding - Known allergy, hypersensitivity or prior infusion reaction to one or more of the therapies incorporated into this treatment protocol. - Bone marrow depression or hematologic parameters in the range that would increase the risk for severe bleeding. Exclusion criteria for participating in MRI monitoring sub-study: Subjects will not be eligible to participate in the MRI response monitoring sub-study, if they have: - Implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical clips (hemostatic clips) or other metallic implants. - Engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or have imbedded metal fragments from military activities. - Received orthodontic work involving ferromagnetic materials. - Claustrophobia (a fear of enclosed spaces). - Previously had an allergic response to MR contrast agents (gadolinium). - Known history of severe renal insufficiency, asthma, allergic conditions, sickle cell anemia, chronic hemolytic anemia, and gastrointestinal disorders.


NCT ID:

NCT02436993


Primary Contact:

Principal Investigator
Rita Mehta, MD
University of California, Irvine

UC Irvine Health Chao Family Comprehensive Cancer Center
Phone: 1-877-UC-STUDY
Email: UCstudy@uci.edu


Backup Contact:

N/A


Location Contact:

Orange, California 92868
United States

Chao Family Comprehensive Cancer Center University of California, Irvine Medical Center
Phone: 877-827-8839
Email: UCstudy@uci.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.