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

ISRCTN	ISRCTN68662102
DOI	https://doi.org/10.1186/ISRCTN68662102
Secondary identifying numbers	CTNZ 01-03; ACTRN12605000377639

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Vernon Harvey
Scientific

Department of Oncology
Auckland Hospital
Private Bag 92024
Auckland
1003
New Zealand

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	CycloX II
Study objectives	A phase II study comparing two chemotherapy treatments for advanced breast cancer - capecitabine and capecitabine with cyclophosphamide. Both drugs being used are taken by mouth, and are both already used to treat breast cancer, but they are not usually used together.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Advanced breast cancer
Intervention	100 mg/m^2/day cyclophosphamide days 1 - 14 plus capecitabine 1331 mg/m^2/day days 1 - 28, every 28 days versus capecitabine 1331 mg/m^2/day days 1-28, every 28 days alone.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	Capecitabine, cyclophosphamide
Primary outcome measure	Added as of 16/12/2008: 1. Toxicity assessed thoughout treatment, assessed 8-weekly during the treatment period 2. Best tumour response, assessed 8-weekly during the treatment period
Secondary outcome measures	Added as of 16/12/2008: 1. Survival measures, assessed at completion of the study 2. Symptom response, assessed throughout treatment
Overall study start date	01/01/2004
Completion date	02/03/2007

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	82 (as of 02/03/2007)
Key inclusion criteria	1. Women with advanced breast cancer (distant metastasis, or T4, N2 or N3, or local recurrence following mastectomy) 2. Measurable disease (Response Evaluation Criteria in Solid Tumors [RECIST]) 3. Treatment with palliative intent 4. At least one prior course of chemotherapy for advanced disease
Key exclusion criteria	Added as of 16/12/2008: 1. Male 2. Less thank six months since last dose of adjuvant chemotherapy 3. More than one prior regimen for advanced disease 4. Pregnant or breast feeding 5. Concurrent anti-cancer therapy 6. Other malignancy within 5 years except adequately treated basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix
Date of first enrolment	01/01/2004
Date of final enrolment	02/03/2007

Department of Oncology

Auckland
1003
New Zealand

Cancer Trials New Zealand (CTNZ) (New Zealand)
Research organisation

Faculty of Medical & Health Sciences
University of Auckland
Private Bag 92019
Auckland
1003
New Zealand

Phone	+64 (0)9 373 7599 ext. 83585
Email	cancertrialsnz@auckland.ac.nz
Website	http://www.ctnz.auckland.ac.nz/

Industry

Roche Products Ltd (New Zealand)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan