A Phase II Study, Comparing a Dose-Titration Regimen of Fulvestrant With the Approved Dosing Regimen in Postmenopausal Patients With Hormone-Responsive Advanced Breast Cancer (ABC) (Fulvestrant Intensity Density Study - Studio FIDeS)
Overview
- Phase
- Phase 2
- Intervention
- Fulvestrant
- Conditions
- Breast Cancer
- Sponsor
- Regina Elena Cancer Institute
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Time to progression (sec. RECIST) or death from any cause; where there is no evidence of progression, TTP will be right-censored at last patients contact where status was recorded
- Last Updated
- 14 years ago
Overview
Brief Summary
In post-menopausal metastatic hormone-responsive breast cancer women.
This study is a two arm randomized trial to evaluate the effectiveness of dose-titration regimen of fulvestrant compared with the approved dosing regimen. Patients will be randomized to one of the following treatment arms:
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
Detailed Description
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
Investigators
Eligibility Criteria
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
Exclusion Criteria
- •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
Arms & Interventions
A - Dose Tritation
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
Intervention: Fulvestrant
B- Control
Fulvestrant 250 mg every 28 days until progression or unacceptable toxicity
Intervention: Fulvestrant
Outcomes
Primary Outcomes
Time to progression (sec. RECIST) or death from any cause; where there is no evidence of progression, TTP will be right-censored at last patients contact where status was recorded
Time Frame: 12 months