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

Phase 2

Completed

• Conditions: arge or locally advanced breast cancer; Cancer; Malignant neoplasm of breast

• Registration Number: ISRCTN00407556
• Lead Sponsor: nited Lincolnshire Hospitals NHS Trust (UK)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-20
• Study Completion: 2011-12-30
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 130

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
6.5. Serum creatinine > 2.0 mg/dL
6.6. Urine protein/creatinine ratio > 1.0 at screening
7. Inability to complete Quality of Life questionnaires
8. Contraindications for modified radical mastectomy (MRM), including contrast media safety, are as for standard magnetic resonance imaging (MRI)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathological response in the breast and axilla, as assessed by the pathologist, following completion of chemotherapy and surgery, using established criteria. The chemotherapy is given over 24 weeks, the surgery is carried out 4 weeks later, and the pathology is available 2 weeks after surgery