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Spots Global Cancer Trial Database for Prediction of Response to Neoadjuvant Chemotherapy in Women With Operable Breast Cancer

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Trial Identification

Brief Title: Prediction of Response to Neoadjuvant Chemotherapy in Women With Operable Breast Cancer

Official Title: Prediction of Response to Neoadjuvant Chemotherapy in Women With Operable Breast Cancer

Study ID: NCT01007890

Conditions

Breast Cancer

Interventions

ChemoFX Assay

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Breastlink Medical Group, Inc, Long Beach, California, United States

USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States

Advanced Medical Specialties, Miami, Florida, United States

Advanced Breast Care, Marietta, Georgia, United States

Missouri Cancer Associates, Columbia, Missouri, United States

Comprehensive Cancer Centers of Nevada, Henderson, Nevada, United States

Breast Care, Las Vegas, Nevada, United States

Morristown Memorial Hospital, Morristown, New Jersey, United States

Beth Israel Medical Center, New York, New York, United States

OU Medical Center, Oklahoma City, Oklahoma, United States

Willamette Valley Cancer Institute and Research Center, Springfield, Oregon, United States

Breast Care Specialists, P.C., Allentown, Pennsylvania, United States

Magee Womens Hospital, Pittsburgh, Pennsylvania, United States

Women & Infants Hospital, Providence, Rhode Island, United States

Breast Clinic of Memphis, Germantown, Tennessee, United States

Advantage Clinical Research, Nashville, Tennessee, United States

Tennessee Breast Specialists, Nashville, Tennessee, United States

Texas Oncology - Bedford, Bedford, Texas, United States

Dallas Surgical Group, Dallas, Texas, United States

Leading Edge Research, PA, Dallas, Texas, United States

Texas Oncology - Dallas Presbyterian Hospital, Dallas, Texas, United States

Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States

Texas Oncology - Memorial City, Houston, Texas, United States

Cancer Care Centers of South Texas, San Antonio, Texas, United States

Southlake Oncology, Southlake, Texas, United States

Texas Oncology - Tyler, Tyler, Texas, United States

Virginia Oncology Associates, Norfolk, Virginia, United States

Aurora Sinai Medical Center, Milwaukee, Wisconsin, United States

Contact Details

Name: Darrell Lis, RN, MSN

Affiliation: Precision Therapeutics

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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