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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000377639

Acronym

Cyclox II

Enrollment

Registered

2005-09-13

Start date

2004-03-30

Completion date

Unknown

Last updated

2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Capecitabine days 1-28 of 28 day cycle vs capecitabine days 1-28 plus oral cyclophosphamide days 1-14 of 28 day cycle.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

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.

Outcome results