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Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
April 2021
NCT02445391Uploaded 09-23-2022
Access via NCI by Request
PDS UID: nci-data-495
A Randomized Phase III Post-operative Trial of Platinum Based Chemotherapy vs. Capecitabine in Patients With Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy
Provider Information
Provider Data DescriptionThere are three submissions for PMID 34092112. This dataset, NCT02445391-D1, contains baseline, treatment, and efficacy data. Dataset NCT02445391-D2 contains data on dose modification. Dataset NCT02445391-D3 contains toxicity data.
SponsorECOG-ACRIN Cancer Research Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies how well cisplatin or carboplatin (platinum based chemotherapy) works compared to capecitabine in treating patients with remaining (residual) basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant). Drugs used in chemotherapy, such as cisplatin, carboplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether cisplatin or carboplatin is more effective than capecitabine in treating patients with residual triple negative basal-like breast cancer.
ConditionsEstrogen Receptor Negative
HER2/Neu Negative
Invasive Breast Carcinoma
Progesterone Receptor Negative
Stage II Breast Cancer
Stage IIA Breast Cancer
Stage IIB Breast Cancer
Stage III Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Triple-Negative Breast Carcinoma
Intervention TypeDrug: Capecitabine
Drug: Carboplatin
Drug: Cisplatin
Drug(s)Drug: Carboplatin
Drug: Cisplatin
Drug: Capecitabine
Total Enrolled415
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm A (observation) (closed to accrual 05/16/2016) - No Intervention
Arm B (cisplatin or carboplatin) - Experimental
Arm C (capecitabine) - Active Comparator
Secondary IDNCI-2014-01820
PubMed (PMID)34092112
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
South Africa
Age Range18 Years and older (Adult, Older Adult)
Files: NCT02445391-D1
Data DictionaryNCT02445391-D1-Data-Dictionary_0.pdf
DATANCT02445391-D1-Dataset_0.csv
OTHERREADME.pdf
Files: NCT02445391-D2
Data DictionaryNCT02445391-D2-Data-Dictionary_0.pdf
DATANCT02445391-D2-Dataset_0.csv
OTHERREADME.pdf
Files: NCT02445391-D3
Data DictionaryNCT02445391-D3-Data-Dictionary_1.pdf
DATANCT02445391-D3-Dataset.csv
OTHERREADME.pdf
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