A Study, Comparing a Dose-Titration Regimen of Fulvestrant With the Approved Dosing Regimen in Postmenopausal Patients With Hormone-Responsive Advanced Breast Cancer (ABC)

Inclusion Criteria

• •Written informed consent
• •Histological or cytological diagnosis of hormone-responsive metastatic breast cancer
• •Documented positive hormone receptor status (ER+ve and/or PgR+ve) of primary or metastatic tumor issue, according to the local laboratory parameters
• •Postmenopausal women, defined as a woman fulfilling any 1 of the following criteria:
• •Age ≥ 60 years
• •Age ≥ 45 years with amenorrhoea ≥ 12 months with an intact uterus
• •Having undergone a bilateral oophorectomy
• •FSH and oestradiol levels in postmenopausal range (utilizing ranges from the local laboratory facility)\*
• •\*In patients who have previously been treated with a monthly LH-RH analogue, the last depot must have been administered more than 13 months (or 15 months in case of 3-monthly LH-RH analogue) prior to randomization, and menses must not have restarted
• •Prior hormonal treatment in adjuvant setting is allowed
• •No more than one prior hormonal treatment for metastatic disease
• •Patients with HER2 positive disease in treatment with specific anti-HER2 therapy (trastuzumab, lapatinib) are allowed
• •ECOG performance status 0-2
• •Patients fulfilling one of the following criteria:
• •Patients with measurable disease as per RECIST criteria. This is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan
• •Patients must have normal organ function as defined below:
• •total bilirubin within normal institutional limits
• •AST (SGOT)/ALT(SGPT) 2.5 X institutional upper limit of normal
• •creatinine within normal institutional limits or creatinine clearance 0.60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal