Prediction of Response to Neoadjuvant Chemotherapy in Women With Operable Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT01007890
- Lead Sponsor
- Precision Therapeutics
- Brief Summary
The objective of this study is to develop a biomarker to predict pathological complete response in women treated with neoadjuvant chemotherapy for breast cancer. Such a biomarker would assist physicians in selecting the most effective chemotherapy for the individual patient.
- Detailed Description
The objective of this study is to develop a biomarker to predict pathological complete response in women treated with neoadjuvant chemotherapy for breast cancer. Such a biomarker would assist physicians in selecting the most effective chemotherapy for the individual patient. The anticipated biomarker will take into account clinical factors (such as tumor stage, tumor size, and age), phenotypic characteristics of the tumor (determined by pathological immunohistochemistry and ex vivo ChemoResponse assay), and genotypic characteristics of the tumor and patient (determined by genomic profiling via gene expression analysis of tumor RNA). It is expected that collective consideration of all of these factors will be more predictive of patient response to therapy than any of them alone.
Approximately 224 evaluable subjects will be recruited from approximately 30 US sites. Women with measurable operable invasive breast cancer diagnosed by core needle biopsy will be eligible for this study. Additional tumor specimens will be obtained prior to the start of chemotherapy via core needle biopsies to be used for the ex vivo ChemoResponse Assay and tumor genomic analysis (gene expression), respectively.
All subjects will receive neoadjuvant chemotherapy with one of two standard of care regimens that must consist of the following agents: doxorubicin (A), cyclophosphamide (C), and a taxane (T) such as docetaxel, paclitaxel, or Abraxane (nanoparticle albumin-bound paclitaxel \[nab-paclitaxel\]); or, docetaxel (T) and cyclophosphamide (C). These must be administered per NCCN guidelines by the treating physician.
Upon completion of chemotherapy treatment, women will undergo lumpectomy, modified radical mastectomy or other surgical procedure determined appropriate by the investigator and at that time will be evaluated for pathological response. At the time of lumpectomy, modified radical mastectomy, or other surgical procedure, additional tumor excess will be sent to Precision Therapeutics, Inc. (Precision) for exploratory analysis if there is no pathologic complete response (pCR), if there are sufficient tumor cells to send, and if the patient agrees to have her excess tumor cells sent to Precision for this purpose.
During the patient's course of participation on the study, the treating physician will remain blinded to the results of the ChemoResponse Assay and genomic analysis. If it is determined there is no pCR at the time of lumpectomy, modified radical mastectomy or other surgical procedure, Precision will make available a subsequent report to the physician containing additional information about chemotherapy drugs other than ACT that could benefit the further treatment decisions for the patient.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 134
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary clinical endpoint pCR will be a dichotomous outcome variable with two levels: complete response and no complete response. 24 months
- Secondary Outcome Measures
Name Time Method Secondary clinical endpoint cOR will be an ordinal outcome variable with complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) four levels. 24 months
Trial Locations
- Locations (28)
Advanced Medical Specialties
🇺🇸Miami, Florida, United States
Breastlink Medical Group, Inc
🇺🇸Long Beach, California, United States
Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
Texas Oncology - Tyler
🇺🇸Tyler, Texas, United States
Southlake Oncology
🇺🇸Southlake, Texas, United States
Missouri Cancer Associates
🇺🇸Columbia, Missouri, United States
OU Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Breast Care
🇺🇸Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Henderson, Nevada, United States
Breast Care Specialists, P.C.
🇺🇸Allentown, Pennsylvania, United States
Beth Israel Medical Center
🇺🇸New York, New York, United States
Willamette Valley Cancer Institute and Research Center
🇺🇸Springfield, Oregon, United States
Advantage Clinical Research
🇺🇸Nashville, Tennessee, United States
Tennessee Breast Specialists
🇺🇸Nashville, Tennessee, United States
Texas Oncology - Bedford
🇺🇸Bedford, Texas, United States
Texas Oncology - Memorial City
🇺🇸Houston, Texas, United States
Cancer Care Centers of South Texas
🇺🇸San Antonio, Texas, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Aurora Sinai Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Advanced Breast Care
🇺🇸Marietta, Georgia, United States
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Texas Oncology - Dallas Presbyterian Hospital
🇺🇸Dallas, Texas, United States
Leading Edge Research, PA
🇺🇸Dallas, Texas, United States
Magee Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Dallas Surgical Group
🇺🇸Dallas, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Breast Clinic of Memphis
🇺🇸Germantown, Tennessee, United States
Women & Infants Hospital
🇺🇸Providence, Rhode Island, United States