Breast Cancer
Conditions
Interventions
investigational material(s)
Generic name etc : ZD9393
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material :
Sponsors
AstraZeneca
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: - Female 20 years or older and pre-menopausal. Pre-menopausal defined as 1) last menses within 1 year of randomisation, and 2) E2 10 pg/mL or more, and FSH 30 mIU/mL or less within 4 weeks of randomisation. For patients who have had a hysterectomy, it is acceptable to meet only 2) - Hormone sensitivity (ER positive) of primary or secondary tumour tissue. - Histological/cytological confirmation of breast cancer and are candidates to receive hormonal therapy as therapy for advanced breast cancer.
Exclusion criteria
Exclusion criteria: - Patients who have received tamoxifen or other hormonal therapies as adjuvant therapy for breast cancer within 24 weeks before randomisation and/or who have received prior treatment with hormonal therapies for advanced breast cancer - Patients who have received LHRHa as adjuvant therapy for breast cancer within 48 weeks before randomisation - Patients who have relapsed during adjuvant hormonal therapy or within 48 weeks after completion of adjuvant hormonal therapy and/or patients who have relapsed during adjuvant chemotherapy or within 24 weeks after completion of adjuvant chemotherapy.
Outcome results
None listed