MedTrace Logo

Efficacy and Safety Study of Neoadjuvant Chemotherapy for Local Advanced Triple Negative Breast Cancer Patients

NCT01216124 · Status: AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2010-10-07

No results posted yet for this study

Summary

The 10%-15% of breast carcinomas known to be 'triple negative (TN)' (not expressing HRs and not exhibiting overexpression Her2) constitutes 85% of all basal-like tumors, because it is based on three standard immunohistochemical biomarkers.

In clinical routine, Docetaxel was widely indicated as first-line therapy for breast cancer patients in adjuvant or neoadjuvant settings. Oxaliplatin, trans-1-diaminocyclohexane-platinum, may offer advantages over other platinum agents. Oxaliplatin promotes formation of DNA adducts, preventing DNA replication and transcription and ultimately causing apoptosis. Oxaliplatin was more potent than cisplatin and the Oxaliplatin-based regimen was active for the patients of lung cancer, colorectal cancer and ect. TNBC patients were more sensitive to platinum-based chemotherapy regimens according to the results of some retrospective studies. There was no report about Oxaliplatin in the chemotherapy setting for breast cancer patients.

The investigators hypothesized that using Oxaliplatin adding to docetaxel would be feasible and active in patients with TNLABC because in vitro findings suggest synergism between the agents. This study was designed to investigate the efficacy and toxicity of oxaliplatin-based regimen as a neoadjuvant chemotherapy setting in triple negative local advanced breast cancer patients

Conditions

  • Triple Negative Local Advanced Breast Cancer

Interventions

DRUG

docetaxel oxaliplatin

docetaxel 75mg/m2 D1 oxaliplatin 130mg/m2 D2 1 cycle=21 days DO\*6

Sponsors & Collaborators

  • Chinese Anti-Cancer Association

    collaborator OTHER

  • Fudan University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01216124 on ClinicalTrials.gov