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Clinical Trials/ISRCTN00407556
ISRCTN00407556
Completed
Phase 2

A phase II, single-centre, randomised study of the effectiveness of the addition of Capecitabine to a standard regimen containing Adriamycin®, Cyclophosphamide and Docetaxel as neoadjuvant treatment in large or locally advanced breast cancers

nited Lincolnshire Hospitals NHS Trust (UK)0 sites130 target enrollmentMay 20, 2011
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Conditionsarge or locally advanced breast cancerCancerMalignant neoplasm of breast

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
arge or locally advanced breast cancer
Sponsor
nited Lincolnshire Hospitals NHS Trust (UK)
Enrollment
130
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29390966

Registry
who.int
Start Date
May 20, 2011
End Date
December 30, 2011
Last Updated
8 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
nited Lincolnshire Hospitals NHS Trust (UK)

Eligibility Criteria

Inclusion Criteria

  • •1\. Women with histologically confirmed carcinoma of the breast, with measurable or evaluable large (greater than or equal to 3 cm) or locally advanced (T3, T4, TxN2\) disease
  • •2\. Women who are over 18 and under 75 years and able to sign the informed consent

Exclusion Criteria

  • •1\. World Health Organisation (WHO) performance status 2, 3 and 4
  • •2\. Prior chemotherapy or radiotherapy unless for basal cell carcinoma
  • •3\. Unstable angina and/or evidence of significant cardiac dysfunction
  • •4\. Patients who have diabetes requiring insulin
  • •5\. Pregnancy or lactation
  • •6\. Inadequate organ function, as evidenced by any of the following laboratory values:
  • •6\.1\. Absolute neutrophil count \< 1500/uL
  • •6\.2\. Platelet count \< 100,000/uL
  • •6\.3\. Total bilirubin \> 1\.5 mg/dL
  • •6\.4\. Alkaline phosphatase, AST, and/or ALT \> 2x upper limit of normal

Outcomes

Primary Outcomes

Not specified

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