Neoadjuvant Study of Two Platinum Regimens in Triple Negative Breast Cancer (NeoSTOP)
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|ClinicalTrials.gov Identifier: NCT02413320|
Recruitment Status : Completed
First Posted : April 9, 2015
Last Update Posted : March 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Triple-negative Breast Cancer||Drug: Paclitaxel Drug: Carboplatin Drug: Doxorubicin Drug: Cyclophosphamide Drug: Docetaxel||Phase 2|
Sporadic and germline BRCA mutation associated triple-negative breast cancer share several pathological and molecular similarities which have led to the exploration of DNA damaging agents like platinum compounds in patients with triple-negative breast cancer. Recent studies demonstrate that addition of neoadjuvant carboplatin to doxorubicin/cyclophosphamide/taxane-based chemotherapy improves pathological complete response in patients with stage I-III triple-negative breast cancer but also increase toxicity.
A recent study reported encouraging pathological complete response rates with a non-anthracycline carboplatin plus docetaxel neoadjuvant chemotherapy regimen in a cohort of 49 triple negative breast cancer patients. This chemotherapy regimen of carboplatin plus docetaxel yielded an overall pathological complete response rate of 65% in unselected triple-negative breast cancer with pathological complete response rates of 61% in sporadic and 77% in germline BRCA-associated triple-negative breast cancer. The chemotherapy regimen of carboplatin/docetaxel is well tolerated and should be studied further and compared with regimens that add carboplatin to the standard anthracycline/taxane containing regimens.
This is the basis for the proposed randomized neoadjuvant phase II study to further estimate and compare pathological complete response rates of carboplatin plus docetaxel x 6 cycles to carboplatin plus paclitaxel x 4 cycles followed by doxorubicin plus cyclophosphamide x 4 cycles in stage I-III triple negative-breast cancer.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Open Label Phase II Trial of Neoadjuvant Carboplatin Plus Docetaxel or Carboplatin Plus Paclitaxel Followed by Doxorubicin Plus Cyclophosphamide in Stage I-III Triple-negative Breast Cancer|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||February 1, 2019|
|Actual Study Completion Date :||February 1, 2020|
Active Comparator: Carboplatin + Paclitaxel then Doxorubicin + Cyclophosphamide
Paclitaxel (80mg/m2) given IV every week x12 weeks and Carboplatin (AUC 6) given IV every 21 days x 4 cycles, followed by Doxorubicin (60mg/m2) given IV and Cyclophosphamide (600mg/m2) given IV every 14 days X 4 cycles
Other Name: taxol
Other Name: paraplatin
Other Name: adriamycin
Other Name: cytoxin, procytox
Active Comparator: Carboplatin + Docetaxel
Carboplatin (AUC 6) given IV and Docetaxel (75mg/m2) given IV every 21 days x 6 cycles
Other Name: paraplatin
Other Name: taxotere
- Pathological complete response rates [ Time Frame: 20 weeks ]To evaluate the pathological complete response rates with neoadjuvant chemotherapy regimens of carboplatin plus paclitaxel x 4 cycles followed by doxorubicin plus cyclophosphamide X 4 cycles and carboplatin plus docetaxel X 6 cycles in subjects with stage I-III triple-negative breast cancer.
- Minimal residual disease rates [ Time Frame: 20 weeks ]To evaluate minimal residual disease rates with two neoadjuvant chemotherapy regimens in subjects with stage I-III triple-negative breast cancer.
- Pathological complete response and minimal residual disease rates in germline BRCA associated and BRCA wild type triple-negative breast cancer [ Time Frame: 20 weeks ]Compare pathological complete response and minimal residual disease rates in subjects with germline BRCA associated and BRCA wild type triple-negative breast cancer with the two neoadjuvant chemotherapy regimens.
- Difference in cost associated with two chemotherapy regimens to treat triple-negative breast cancer [ Time Frame: 20 weeks ]Assessment of cost associated with the delivery of the two chemotherapy regimens.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02413320
|United States, Kansas|
|University of Kansas Cancer Center - CRC|
|Fairway, Kansas, United States, 66205|
|Hays Medical Center|
|Hays, Kansas, United States, 67601|
|University of Kansas Cancer Center - Overland Park|
|Overland Park, Kansas, United States, 66210|
|Salina Regional Health Center|
|Salina, Kansas, United States, 67401|
|University of Kansas Cancer Center - Westwood|
|Westwood, Kansas, United States, 66205|
|United States, Missouri|
|Truman Medical Center|
|Kansas City, Missouri, United States, 64108|
|University of Kansas Cancer Center - South|
|Kansas City, Missouri, United States, 64131|
|University of Kansas Cancer Center - North|
|Kansas City, Missouri, United States, 64154|
|University of Kansas Cancer Center - Lee's Summit|
|Lee's Summit, Missouri, United States, 64064|
|Principal Investigator:||Priyanka Sharma, MD||University of Kansas Medical Center|