NCT01818063
Version 15 to 16 · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Patch inspector
Manual review pending.
None recorded.
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] e3b369ea735788fc9ca968e448e3569bef419b298509d5a9edf84dc9a3a61cfd/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. At the time of surgery
36 months following surgery
/protocolSection/statusModule/statusVerifiedDate 2017-12
2018-01
/protocolSection/statusModule/lastUpdateSubmitDate 2017-12-14
2018-01-16
/protocolSection/statusModule/lastUpdatePostDateStruct/date 2018-01-16
2018-02-13
/protocolSection/descriptionModule/detailedDescription <p>PRIMARY OBJECTIVE:</p><p>1) To compare the pathologic complete response (path CR) in patients with stage IIB or stage III triple negative breast cancer treated with neoadjuvant paclitaxel and carboplatin to the path CR of patients treated with paclitaxel, carboplatin, and veliparib.</p><p>SECONDARY OBJECTIVES:</p><ol><li>Relapse free survival (follow-up period of 36 months).</li><li>Overall clinical response to neoadjuvant therapy.</li><li>To determine whether expression of 5 biomarkers (cytokeratin [CK]5, endothelial growth factor receptor [EGFR], excision repair cross complementing 1 [ERCC1], Ki67, poly[adenosine diphosphate (ADP)-ribosyl]transferase [Parp1]) correlate with a higher pCR in response to a particular treatment combination. 4) To determine whether tumors with biomarker signatures that are most like breast cancer (BRCA)-mutated tumors (high expression of CK5 and high expression of EGFR), will correlate with a higher likelihood of pCR with treatment with a PARP inhibitor in combination with chemotherapy.</li></ol><p>5) To determine whether tumors with high expression of the markers ERCC1, Ki67, and Parp1 will correlate with a higher rate of pCR with platinum agents in combination with paclitaxel or a PARP inhibitor.</p><p>6) To correlate response of tumor on imaging (magnetic resonance imaging [MRI], ultrasound [US], and positron emission tomography [PET]/computed tomography [CT]) with path CR.</p><p>7) To correlate levels of circulating tumor cells (CTCs) with pathologic CR.</p><p>TERTIARY OBJECTIVES:</p><ol><li>To evaluate additional exploratory biomarkers based on evidence of possible prognostic or predictive value: BRCA1/BRCA2 complete mutational and rearrangement test. CK14, CK17, cyclin B1, cluster of differentiation (CD)44, CD24, cyclin D1, vimentin, thymidine phosphorylase, inhibitor of differentiation (ID)4, p53, p63, p73, differentiated embryo-chondrocyte expressed gene (Dec)1, phospho-HistoneH3, thymidylate synthase, p16, gammaH2AX, geminin, RAD51.</li><li>To determine which arms are best tolerated by patients with co-morbid conditions, such as hypertension and diabetes.</li></ol><p>OUTLINE: Patients are randomized to 1 of 2 treatment arms.</p><p>ARM I: Patients receive paclitaxel intravenously (IV) and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>ARM II: Patients receive veliparib orally (PO) twice daily (BID) on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>After completion of study treatment, patients are followed up every 3 months for 36 months.</p>
<p>PRIMARY OBJECTIVE:</p><p>1) To compare the pathologic complete response (path CR) in patients with stage IIB or stage III triple negative breast cancer treated with neoadjuvant paclitaxel and carboplatin to the path CR of patients treated with paclitaxel, carboplatin, and veliparib.</p><p>SECONDARY OBJECTIVES:</p><ol><li>Relapse free survival (follow-up period of 36 months).</li><li>Overall clinical response to neoadjuvant therapy.</li></ol><p>OUTLINE: Patients are randomized to 1 of 2 treatment arms.</p><p>ARM I: Patients receive paclitaxel intravenously (IV) and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>ARM II: Patients receive veliparib orally (PO) twice daily (BID) on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>After completion of study treatment, patients are followed up every 3 months for 36 months.</p>
/resultsSection/baselineCharacteristicsModule/measures/4/paramType NUMBER
COUNT_OF_PARTICIPANTS
/resultsSection/baselineCharacteristicsModule/measures/4/unitOfMeasure participants
Participants
/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame At the time of surgery
36 months following surgery
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"value": "<p>PRIMARY OBJECTIVE:</p><p>1) To compare the pathologic complete response (path CR) in patients with stage IIB or stage III triple negative breast cancer treated with neoadjuvant paclitaxel and carboplatin to the path CR of patients treated with paclitaxel, carboplatin, and veliparib.</p><p>SECONDARY OBJECTIVES:</p><ol><li>Relapse free survival (follow-up period of 36 months).</li><li>Overall clinical response to neoadjuvant therapy.</li></ol><p>OUTLINE: Patients are randomized to 1 of 2 treatment arms.</p><p>ARM I: Patients receive paclitaxel intravenously (IV) and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>ARM II: Patients receive veliparib orally (PO) twice daily (BID) on days 1-5.\nPatients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>After completion of study treatment, patients are followed up every 3 months for 36 months.</p>"
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