None listed
Conditions
Brief summary
The proposal in this protocol is to determine (in patients with advanced breast cancer) whether it is better, at disease progression, to continue the policy of substituting the original therapy with a replacement; or alternatively to continue the original treatment and add the new therapy to it, since the existing therapy may be controlling some previously active disease sites.
Interventions
ANZ 8613 is a phase III study evaluating the subsitution versus addition of endocrine therapy at the point of disease progression in patients with advanced breast cancer.
Eligible patients are randomised to one of two treatment arms:
Arm A: Continue tamoxifen + MPA (medroxyprogesterone acetate)
Arm B: Stop tamoxifen + begin MPA (medroxyprogesterone acetate)
In Arm A, tamoxifen is administered in oral tablet form, at the same dose and schedule the patient is receiving at baseline (ie at the tim
ANZ 8613 is a phase III study evaluating the subsitution versus addition of endocrine therapy at the point of disease progression in patients with advanced breast cancer. Eligible patients are randomised to one of two treatment arms: Arm A: Continue tamoxifen + MPA (medroxyprogesterone acetate) Arm B: Stop tamoxifen + begin MPA (medroxyprogesterone acetate) In Arm A, tamoxifen is administered in oral tablet form, at the same dose and schedule the patient is receiving at baseline (ie at the time of progressive disease). In both Arm A and Arm B, MPA is administered orally in a daily dose of 500 mg, commencing on the day of randomisation. Patients randomised to Arm B should stop (non-protocol) tamoxifen prior to commencing protocol therapy with MPA. For both Arms, patients should remain on only the randomised treatment for a minimum of four (4) weeks before any progressive disease is confirmed or new treatment introduced. All therapies used in this study are standard - the uniqueness of this protocol is in the way these therapies are used.
Sponsors
Australian New Zealand Breast Cancer Trials Group (ANZ BCTG)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Established advanced breast cancer who have been receiving tamoxifen therapy for more than 6 months and have had documented progression of disease while on treatment and at least 6 months after beginning treatment. Key Inclusion criteria: - Histologically confirmed primary breast cancer. - Progressive disease while on tamoxifen after at least 6 months of treatment with tamoxifen. - Objective evidence of evaluable or measurable recurrent, locally advanced and/or metastatic disease. - Post menopausal patients are eligible- Performance status of 3 or better (0-3), and survival expectation is at least three months. - Geographically accessible for follow-up- Informed consent obtained according to the standards required by the eithics and/or research committees of the participating institutions.
Exclusion criteria
Past or current malignancy arising from sites other than the breast, except for adequately treated squamous or basal cell carcinoma of the skin, or in situ carcinoma of the cervix- Patients whose only demonstrable disease is intracranial- Prior treatment with MPA- Patients who only evidence of disease is asymptomatic abnormality on bone scan (ie plain x-ray does not demonstrate malignancy)Special consideration for eligibility may include:- Patients with established unequivocal oestrogen receptor (ER) negative status of metastatic and/or recurrent disease may be included- Patients with documented ER negative status of their original primary tumours are also eligible for this study- Patients who have relapsed on adjuvant tamoxifen or who have had prior tamoxifen adjuvant therapy are eligible for this trial provided they have been on tamoxifen for 6 months and are still receiving it at the time of entry to the study.
Outcome results
None listed