Phase 3 N=1,491 Randomized Treatment

Docetaxel in Node Positive Adjuvant Breast Cancer

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00688740 ↗

Enrolled (actual)

1,491

Serious AEs

22.6%

Results posted

Feb 2011

Primary outcome: Primary: Number of Participants With Disease-Free Survival Events — 287; 333 Participants — p=0.0043

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Docetaxel (Drug); 5-fluorouracil (Drug); Doxorubicin (Drug); Cyclophosphamide (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Sanofi
Primary completion: Jan 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Disease-Free Survival Events	287; 333	0.0043 sig
SECONDARY Number of Participants With Overall Survival Events	188; 241	0.0020 sig
SECONDARY Number of Participants With Second Primary Malignancies (Toxicity)	67; 66	—

Summary

The purpose of this study was to compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to 5-fluorouracil in combination with doxorubicin and cyclophosphamide in operable breast cancer patients with positive axillary lymph nodes.

Eligibility Criteria

Inclusion Criteria

Histologically proven breast cancer (invasive adenocarcinoma with at least one axillary lymph node showing evidence of tumor among a minimum of six resected lymph nodes).
Definitive surgical treatment must be either mastectomy, or breast conserving surgery with axillary lymph node dissection for operable breast cancer. Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma.

Exclusion criteria

Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy).
Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy.

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Data sourced from ClinicalTrials.gov (NCT00688740). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.