A randomised phase II study comparing capecitabine with capecitabine and oral cyclophosphamide in patients with advanced breast cancer

Recruiting

• Conditions: Advanced breast cancer; Cancer - Breast

• Registration Number: ACTRN12605000377639
• Lead Sponsor: Cancer Trials New Zealand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

Histological or cytological evidence of breast carcinoma with at least one of the following: distant metasteses, T4 or N2 or N3, or loacal recurrence following mastectomy;measurable disease; treatment with palliative intent; performace status 0-3 (WHO); aequate bone marrow, renal and liver fnction and creatinine clearance > 50ml/min.

Exclusion Criteria

Male; less thank six months since last dose of adjuvant chemotherapy; more than one prior regimen for advanced disease; pregnant or breast feeding; concurrent anticancer therapy; other malignancy within 5 years except adequately treated basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of teh cervix.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Toxicity assessed thoughout treatment[Assessed 8 weekly during the treatment period];Best tumour response[Assessed 8 weekly during the treatment period]

Secondary Outcome Measures

Name	Time	Method
Survival measures[Assessed at completion of the study.];Symptom response[Throughout treatment.]