NCTN: 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 (EA1131)

Study ID: EA1131

NCT Number: NCT02445391

ECOG-ACRIN Cancer Research Group

Submitted in collaboration with the NCTN/NCORP Data Archive

Trial Title: NCTN: 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 (EA1131)

Trial Description: This 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.

Clinical data presented in the following publication(s):

• PMID 34092112

Disease type(s): Breast Neoplasm - Breast Cancer - Invasive

Clinical dataset(s) included:

• NCT02445391-D1 (PMID 34092112): There are three datasets for PMID 34092112. This dataset, NCT02445391-D1, contains baseline characteristics, stratification factors, treatment, second primary cancer, cause of death and efficacy data. The data reflect the study database as of April 7, 2021. All patients who were randomized to one of the three arms were included in the database (NCT02445391-D1). Accrual was open to arm A (observation) and arm B (platinum) prior to Amendment #3, and accrual to arm A was permanently closed and accrual to arm C (capecitabine) was opened in Amendment #3.
• NCT02445391-D2 (PMID 34092112): There are three datasets for PMID 34092112. This dataset, NCT02445391-D2 contains data on dose modification. The data reflect the study database as of April 7, 2021.
• NCT02445391-D3 (PMID 34092112): There are three datasets for PMID 34092112. This dataset, NCT02445391-D3, contains toxicity data. The data reflect the study database as of April 7, 2021. All treatment-related AEs were included in the database, and only the worst degree was reported in the paper.

You are encouraged to view the PDF data dictionaries found in the “Documents” tab of the dbGaP study page, which may contain additional information regarding the data or the associated publication(s).

• Type: Interventional
• Archive: The database of Genotypes and Phenotypes (dbGaP)