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

NCT00927511 | Unknown Phase 2

• 1 other identifier: FIDeS
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Keywords

metastatic hormone-responsive breast cancer menopausal women

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Study Arms (2)

A - Dose Tritation

EXPERIMENTAL

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

Drug: Fulvestrant

B- Control

ACTIVE COMPARATOR

Fulvestrant 250 mg every 28 days until progression or unacceptable toxicity

Drug: Fulvestrant

Interventions

Fulvestrant DRUG

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 vs Fulvestrant 250 mg every 28 days until progression or unacceptable toxicity

Also known as: Faslodex

A - Dose Tritation; B- Control

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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

You may not qualify 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

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead
• AstraZeneca: collaborator

Study Sites (1)

Regina Elena Cancer Institute

Rome, RM, 00144, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Paola Papaldo, MD

  Regina Elena Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Papaldo Paola, MD

CONTACT

06-52666230; p.papaldo@mclink.it

Giannarelli Diana, MS

CONTACT

giannarelli@ifo.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 24, 2009
• First Posted: June 25, 2009
• Study Start: October 1, 2008
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: July 22, 2011

Record last verified: 2009-06

Locations

IT (1)