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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Regina Elena Cancer Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Regina Elena Cancer Institute
ClinicalTrials.gov Identifier:
NCT00927511
First received: June 24, 2009
Last updated: July 21, 2011
Last verified: June 2009
  Purpose

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


Condition Intervention Phase
Breast Cancer
Drug: Fulvestrant
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Regina Elena Cancer Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 104
Study Start Date: October 2008
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: Fulvestrant
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
Other Name: Faslodex
Active Comparator: B- Control
Fulvestrant 250 mg every 28 days until progression or unacceptable toxicity
Drug: Fulvestrant
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
Other Name: Faslodex

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

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  • 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 with bone lesions, lytic or mixed (lytic + sclerotic), in the absence of measurable disease as defined by RECIST criteria. Bone lesions must be evaluable by plain X-ray, CT or MRI. Patients with lesions identified only on radionucleotide bone scan are not eligible
  • Patients with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical carcinoma in situ, melanoma in situ, and basal cell or squamous cell carcinoma of the skin
  • 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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927511

Contacts
Contact: Papaldo Paola, MD 06-52666230 p.papaldo@mclink.it
Contact: Giannarelli Diana, MS giannarelli@ifo.it

Locations
Italy
Regina Elena Cancer Institute Recruiting
Rome, RM, Italy, 00144
Contact: Papaldo Paola, MD    06-52666230    p.papaldo@mclink.it   
Principal Investigator: Papaldo Paola, MD         
Sponsors and Collaborators
Regina Elena Cancer Institute
AstraZeneca
Investigators
Principal Investigator: Paola Papaldo, MD Regina Elena Cancer Institute
  More Information

No publications provided

Responsible Party: Paola Papaldo, Regina Elena Cancer Institute
ClinicalTrials.gov Identifier: NCT00927511     History of Changes
Other Study ID Numbers: FIDeS
Study First Received: June 24, 2009
Last Updated: July 21, 2011
Health Authority: Italy: AIFA

Keywords provided by Regina Elena Cancer Institute:
metastatic hormone-responsive breast cancer menopausal women

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Estradiol
Fulvestrant
Hormones
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Estrogen Antagonists
Estrogen Receptor Modulators
Estrogens
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014