The purpose of this study is to determine whether platinum-based chemotherapy (either cisplatin or carboplatin), when given with radiation therapy prior to surgery, is effective in improving response to treatment in triple negative breast cancer patients. This treatment is being studied in this type of breast cancer because it does not respond well to commonly used treatments such as tamoxifen or herceptin.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Washington University School of Medicine
St Louis, Missouri, United States
Response Rate as Measured by Number of Participants Who Achieved Complete Response (CR) or Partial Response (PR)
* Complete response (CR) = disappearance of all target lesions, disappearance of all non-target lesions and normalization of tumor marker level. * Partial response (PR) = at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD
Time frame: Prior to surgery (approximately 12-16 weeks from registration)
Relationship Between Tumor Response and Deficiencies in DNA Repair Mechanisms
Time frame: Prior to surgery (approximately 12-16 weeks from registration)
Time to Disease Progression
Progression = at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, unequivocal progression of existing non-target lesions.
Time frame: Up to 5 years from registration
Number of Participants With Surgical Complications
Time frame: 30 days post surgery (approximately 16-20 weeks from registration)
Determine the Effect of Neoadjuvant Chemoradiation Therapy in Disseminated Cancer Cells in the Bone Marrow
Time frame: Up to 15 months from registration
Overall Survival Rate
Time frame: Median follow-up was 59.9 months
Medical Toxicities as Measured by Number of Grade 3 or Higher Adverse Events
Time frame: 30 days post surgery (approximately 16-20 weeks after start of registration)
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Successful Development of Animal Models of Triple Negative Breast Cancers as Measured by the Ability to Grow the Tumors in Mice.
Time frame: At the time of IVAD placement and at the time of surgery
Successful Development of Animal Models for Triple Negative Breast Cancers as Measured by the Ability to Passage the Tumors in Mice
Time frame: At the time of IVAD placement and at the time of surgery
Successful Development of Animal Models in Triple Negative Breast Cancers as Measured by the Ability of the Tumors to Metastasize to Other Organs
Time frame: At the time of IVAD placement and at the time of surgery
Successful Development of Animal Models of Triple Negative Breast Cancer as Measured by the Genetic Similarity Between the Primary Tumor and the Tumor in Animals
Time frame: At the time of IVAD placement and at the time of surgery
Determine the Effect of Neoadjuvant Chemoradiation Therapy in Disseminated Cancer Cells in the Bone Marrow and the Correlation to Tumor Response
Time frame: Up to 15 months from time of registration