NCT00620100: Docetaxel and anthracyclines for breast cancer

NCT00620100 was Sanofi's phase II docetaxel/anthracycline breast-cancer study, protocol XRP6976A_2504. It planned treatment for 100 patients with HER2-negative locally advanced or metastatic disease after relapse following earlier docetaxel treatment. Only two patients entered, and Sanofi's clinical-study-report synopsis explicitly states that poor recruitment caused early termination. 1 2

The planned sequence was four cycles of docetaxel plus doxorubicin or epirubicin, followed by four cycles of docetaxel alone. One patient received one cycle, experienced serious grade 3 febrile leucopenia, discontinued and was not evaluable for tumor response. 2

The second received six cycles, had stable disease after cycle three, and died from pulmonary embolism during cycle six. The report does not permit a reliable efficacy analysis. Its observed adverse events and death must not be omitted behind a generic “terminated” label, but neither can a two-patient experience establish a comparative drug-caused risk. 2

The original sponsor synopsis is the relevant results resource, rather than outcomes from a larger taxane regimen with a similar name. 2

Sources

1. ClinicalTrials.gov — ClinicalTrials.gov — NCT00620100. Original registration; establishes the exact study identity and registered methods.Original study registration · Original record checked against the registry API. Checked 2026-10-10. Registration and current registry fields do not by themselves establish efficacy. Historical details in the article retain their stated date. Supplied note: ClinicalTrials.gov — NCT00620100. Original registration; establishes the exact study identity and registered methods.