None listed
Conditions
Brief summary
Breast cancer sometimes recurs locally (comes back in the breast, chest or lymph nodes) despite the best initial treatment. Women with breast cancer that has recurred locally are usually treated with further surgery, radiation and/or hormone therapy. This international phase III trial will determine if adding chemotherapy to the standard treatment for a local recurrence can further improve cure rates for such women. Women who enter the trial will be randomly assigned to receive standard treatment or standard treatment plus chemotherapy. The type of chemotherapy will be chosen by the treating doctor.
Interventions
BCSG 27-02 is being conducted internationally by the International Breast Cancer Study Group (IBCSG). The study is coordinated in Australia and New Zealand by Breast Cancer Trials (formerly the Australia and New Zealand Breast Cancer Trials Group). This trial will evaluate the efficacy of adjuvant chemotherapy after radical treatment of a first loco-regional recurrence of breast cancer. IBCSG 27-02 is an international, multicentre, randomised phase III clinical trial of 977 patients with radical
BCSG 27-02 is being conducted internationally by the International Breast Cancer Study Group (IBCSG). The study is coordinated in Australia and New Zealand by Breast Cancer Trials (formerly the Australia and New Zealand Breast Cancer Trials Group). This trial will evaluate the efficacy of adjuvant chemotherapy after radical treatment of a first loco-regional recurrence of breast cancer. IBCSG 27-02 is an international, multicentre, randomised phase III clinical trial of 977 patients with radically treated isolated local and/or regional recurrence of invasive breast cancer after mastectomy or breast-conserving surgery. Women will be randomised in a 2-arm design to receive one of the following: a. Chemotherapy b. Observation Patients may receive radiation therapy and hormonal treatment if the tumour is hormone receptor positive. The adjuvant chemotherapy and hormonal therapy regimen selected is at the discretion of the treating clinician in accord with protocol guidelines. Hormonal therapy is mandatory for patients with ER and or PgR receptor positive tumours. The type and duration of the hormonal therapy is at the discretion of the treating clinician, and will be based on the patient's menopausal status and any previous hormonal therapy treatment. Standard doses and agents should be used. The adjuvant chemotherapy is preferred to consist of 2 or more drugs for a duration of between 3 and 8 cycles, to commence within 4 weeks of randomisation and within 10 weeks of loco-regional recurrence. Radiotherapy is mandatory for patients who have not received prior adjuvant radiotherapy.
Sponsors
Breast Cancer Trials
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
Histologically verified first local and/or regional recurrence of invasive breast cancer following mastectomy or breast conserving treatment; surgical resection with clear, or macroscopically involved margins; planned radiotherapy for patients who had no prior adjuvant radiation treatment or who have macroscopically involved margins; hormone receptor positive tumour; medically suitable for chemotherapy of 3 to 6 months duration, signed informed consent provided and geographically accessible for follow up.
Exclusion criteria
Patients with macroscopically incomplete surgery; evidence of distant metastasis; patients with microscopically involved margins and for whom local radiation therapy is impossible; bilateral invasive breast cancer; patients who have had a prior recurrence in any site (except the first loco-regional recurrence); patients, who, before randomization, have a skeletal pain of unknown cause, elevated alkaline phosphatase; patients with other primary malignant tumors except adequately treated carcinoma in situ of the uterine cervix and non-melanoma skin cancer; other non-malignant systemic diseases that would prevent undergoing any of the treatment options, or prolonged follow-up.
Outcome results
None listed