A Study, Comparing a Dose-Titration Regimen of Fulvestrant With the Approved Dosing Regimen in Postmenopausal Patients With Hormone-Responsive Advanced Breast Cancer (ABC)
Arm A: Fulvestrant 500 mg days 0, 14, 28, then 250 mg every 2 weeks for 5 administrations, then 250 mg every 28 days, until progression or unacceptable toxicity Arm B: Fulvestrant 250 mg every 28 days until progression or unacceptable toxicity
Age
45–85
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
Receive concurrent treatment with an investigational agent or participate in another clinical trial
Have a concurrent disease or condition that would make the patient inappropriate for study participation, or any serious medical disorder that would interfere with the patient safety
Patients with responsive or stable disease after chemotherapy (fulvestrant administration in not allowed as maintenance therapy)
More than 1 line of chemotherapy in metastatic setting; more than 1 maintenance hormonal therapy
Life expectancy \< 6 months
Have an active or uncontrolled infection
Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
History of bleeding diathesis, or long term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin)
History of hypersensitivity to active or inactive excipients of Fulvestrant
Clareo Health | A Study, Comparing a Dose-Titration Regimen of Fulvestrant With the Approved Dosing Regimen in Postmenopausal Patients With Hormone-Responsive Advanced Breast Cancer (ABC)
