None listed
Conditions
Brief summary
This study aims to evaluate the efficacy of maintenance chemotherapy in women with hormone non-responsive breast cancer. Who is it for? You may be eligible join this study if you are a woman with receptor-negative primary breast cancer and are in adequate health to begin or continue with induction chemotherapy. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will undergo induction chemotherapy followed by maintenance chemotherapy. Maintenance chemotherapy involves taking one 50mg cyclophosphamide tablet daily for one year and two 2.5mg methotrexate tablets twice a day on days 1 and 2 of every week for one year. Participants in the other group will undergo induction chemotherapy only. This will be administered at the doctor's discretion. Participants will be regularly assessed over the duration of the trial to determine whether maintenance chemotherapy delays tumor recurrence and prolongs survival.
Interventions
IBCSG 22-00 is co-ordinated internationally by the International Breast Cancer Study Group (IBCSG). The trial is conducted in Australia and New Zealand by the Australian New Zealand Breast Cancer Trials Group.
This protocol is designed to determine if maintenance chemotherapy with low dose cyclophosphamide and methotrexate given for 12 months following 3 to 6 months of induction cytotoxic chemotherapy improves outcome compared with induction chemotherapy alone. The maintenance chemotherapy (CM)
IBCSG 22-00 is co-ordinated internationally by the International Breast Cancer Study Group (IBCSG). The trial is conducted in Australia and New Zealand by the Australian New Zealand Breast Cancer Trials Group. This protocol is designed to determine if maintenance chemotherapy with low dose cyclophosphamide and methotrexate given for 12 months following 3 to 6 months of induction cytotoxic chemotherapy improves outcome compared with induction chemotherapy alone. The maintenance chemotherapy (CM) regimen has demonstrated activity in metastatic breast cancer and an interference with angiogenic serum factors. It is hypothesized that this regimen will delay tumor recurrence. IBCSG 22-00 is an international, multicentre, clinical trial of 900 patients who have had histologically or cytologically confirmed, receptor-negative primary breast cancer. Women will be randomised in a 2-arm design to receive one of the following: a. Induction Chemotherapy b. Induction Chemotherapy followed by 12 months maintenance chemotherapy Patients randomised to the chemotherapy maintenance arm will receive oral low dose chemotherapy consisting of 50mg cyclophosphamide daily for one year and 2.5mg methotrexate twice a day, days 1 and 2 every week for one year.
Sponsors
Australia and New Zealand Breast Cancer Trials Group
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
No
Inclusion criteria
Premenopausal or postmenopausal patients with histologically proven, receptor-negative primary breast cancer who are in adequate health to begin or continue with induction chemotherapy, have completed baseline Quality of Life forms, are geographically accessible for follow-up and have signed written informed consent.
Exclusion criteria
Patients with bilateral disease, positive margins in the resected tumour specimen, previous or concomitant malignancy, patients who have received prior therapy for breast cancer, or who have non-malignant systemic diseases that would prevent them from undergoing any trial treatment options, or who are pregnant or lactating within 6 months of diagnosis.
Outcome results
None listed