Condition category
Cancer
Date applied
29/08/2003
Date assigned
28/10/2003
Last edited
16/12/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Vernon Harvey

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CTNZ 01-03; ACTRN12605000377639

Study information

Scientific title

Acronym

CycloX II

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Phase II

Drug names

Capecitabine, cyclophosphamide

Primary outcome measures

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 trial start date

01/01/2004

Overall trial end date

02/03/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

82 (as of 02/03/2007)

Participant 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

Recruitment start date

01/01/2004

Recruitment end date

02/03/2007

Locations

Countries of recruitment

New Zealand

Trial participating centre

Department of Oncology
Auckland
1003
New Zealand

Sponsor information

Organisation

Cancer Trials New Zealand (CTNZ) (New Zealand)

Sponsor details

Faculty of Medical & Health Sciences
University of Auckland
Private Bag 92019
Auckland
1003
New Zealand
+64 (0)9 373 7599 ext. 83585
cancertrialsnz@auckland.ac.nz

Sponsor type

Research organisation

Website

http://www.ctnz.auckland.ac.nz/

Funders

Funder type

Industry

Funder name

Roche Products Ltd (New Zealand)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes