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Clinical Trials/ISRCTN38983527
ISRCTN38983527
Completed
N/A

Phase I/II single-arm interventional pilot study of capecitabine with or without vinorelbine after sequential dose-dense epirubicin and paclitaxel in high-risk early breast cancer

AGO Breast Study Group (Arbeitsgeinschaft für Gynäkolgische Onkologie) (Germany)0 sites50 target enrollmentSeptember 1, 2009
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ConditionsBreast cancerCancerMalignant neoplasm of the breast

Overview

Phase
N/A
Intervention
Not specified
Conditions
Breast cancer
Sponsor
AGO Breast Study Group (Arbeitsgeinschaft für Gynäkolgische Onkologie) (Germany)
Enrollment
50
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 1, 2009
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
AGO Breast Study Group (Arbeitsgeinschaft für Gynäkolgische Onkologie) (Germany)

Eligibility Criteria

Inclusion Criteria

  • •1\. Aged 18 to 65 years, female
  • •2\. Histologically confirmed stage II/IIIA breast cancer with four or more positive axillary lymph nodes
  • •3\. Had undergone surgery (complete surgical resection \[R0] of breast tumour and axilla) before inclusion in the study
  • •4\. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • •5\. Left ventricular ejection fraction within the normal institutional range
  • •6\. Adequate haematological, renal and hepatic function
  • •7\. Provided written informed consent

Exclusion Criteria

  • •1\. Inflammatory breast cancer
  • •2\. Received neoadjuvant endocrine therapy, chemotherapy or radiotherapy
  • •3\. Known dihydropyrimidine dehydrogenase deficiency
  • •4\. Creatinine clearance less than 30 mL/min
  • •5\. Impaired organ function
  • •6\. Metastatic disease

Outcomes

Primary Outcomes

Not specified

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