Prediction of Response to Neoadjuvant Chemotherapy in Women With Operable Breast Cancer
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.
Observational
Observational Model: Cohort, Time Perspective: Prospective
Primary clinical endpoint pCR will be a dichotomous outcome variable with two levels: complete response and no complete response.
24 months
No
Darrell Lis, RN, MSN
Study Director
Precision Therapeutics
Department of Defense, U.S. Army Medical Research and Materiel Command, US:
PT-304
NCT01007890
November 2009
October 2012
Name | Location |
---|---|
USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
Morristown Memorial Hospital | Morristown, New Jersey 07962-1956 |
Beth Israel Medical Center | New York, New York 10003 |
Virginia Oncology Associates | Newport News, Virginia 23606 |
Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada 89109 |
Missouri Cancer Associates | Columbia, Missouri 65201 |
Aurora Sinai Medical Center | Milwaukee, Wisconsin 53201-0342 |
OU Medical Center | Oklahoma City, Oklahoma 73104 |
Cancer Care Centers of South Texas | San Antonio, Texas 78229 |
Advanced Medical Specialties | Miami, Florida 33176 |
Women & Infants Hospital | Providence, Rhode Island 02905-2499 |
Dallas Surgical Group | Dallas, Texas 75235 |
Willamette Valley Cancer Institute and Research Center | Springfield, Oregon 97477 |
Texas Oncology - Tyler | Tyler, Texas 75702 |
Southlake Oncology | Southlake, Texas 76092 |
Breastlink Medical Group, Inc | Hawthorne, California 90250 |
Tennessee Breast Specialists | Nashville, Tennessee 37203 |
Advanced Breast Care | Marietta, Georgia 30060 |
Texas Oncology - Bedford | Bedford, Texas 76022 |
Breast Care | Las Vegas, Nevada 89106 |
Breast Care Specialists, P.C. | Allentown, Pennsylvania 18104 |
Magee Womens Hospital | Pittsburgh, Pennsylvania 15213 |
Breast Clinic of Memphis | Germantown, Tennessee 38138 |
Advantage Clinical Research | Nashville, Tennessee 37203 |
Leading Edge Research, PA | Dallas, Texas 75230 |
Texas Oncology - Dallas Presbyterian Hospital | Dallas, Texas 75231 |
Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas, Texas 75246 |
Texas Oncology - Memorial City | Houston, Texas 77024 |