None listed
Conditions
Brief summary
A phase III study to compare the effect of 'Zoladex' with 'Zoladex plus Nolvadex' in pre- and peri-menopausal patients with advanced breast cancer.
Interventions
Arm B: Zoladex plus Nolvadex
Nolvadex (in Arm B and only after on-treatment progression in Arm A) is administered orally, in tablet form, at a dose of 40 mg (ie two tablets) once daily.
Patients will receive study therapy until one of the following treatment endpoints is reached:
a) Severe adverse reaction,
b) Patient unwilling/unable to continue therapy,
c) Objective progression of breast cancer,
d) Death,
e) Study inclusion/exclusion criteria are violated at any time,
f) Patient receives syste
Arm B: Zoladex plus Nolvadex Nolvadex (in Arm B and only after on-treatment progression in Arm A) is administered orally, in tablet form, at a dose of 40 mg (ie two tablets) once daily. Patients will receive study therapy until one of the following treatment endpoints is reached: a) Severe adverse reaction, b) Patient unwilling/unable to continue therapy, c) Objective progression of breast cancer, d) Death, e) Study inclusion/exclusion criteria are violated at any time, f) Patient receives systemic treatment for breast cancer or receives non-protocol treatment, known to effect hormonal status. All patients will be followed up until the last patient has been followed up for at least 1 year, or has withdrawn from the study (whichever occurs first).
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
a) Histologically or cytologically proven diagnosis of invasive primary breast cancer.b) Locally recurrent or locally advanced breast cancer (a locally advanced breast cancer which is 5cm diameter or greater on clinical measurement or fixed to the chest wall - T1b, T2b, T3b or T4) or distant metastases in bone, lung or soft tissue.c) One measurable or evaluable lesion.d) Pre or peri-menopausal women e) Informed consent to participate in the trial.
Exclusion criteria
a) Adjuvant hormone or adjuvant anti-hormone therapy within the last 6 months.b) Adjuvant cytotoxic therapy within the last six months. Patients who are amenorrhoeic more than six months after adjuvant cytotoxic therapy should have menopausal status confirmed by serum levels of FSH.c) Prior therapy for advanced disease at any time.d) Concurrent invasive malignancy within the last five years.e) Pregnancyf) Pre-existing sex endocrine disorders.
Outcome results
None listed