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A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer. (FALCON)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01602380
First received: May 11, 2012
Last updated: April 7, 2017
Last verified: April 2017
  Purpose
The purpose of the study is to compare how treatment with Fulvestrant (FASLODEX) or Anastrozole (ARIMIDEX) effects disease progression for women with locally advanced or metastatic breast cancer who have not had prior hormonal treatment.

Condition Intervention Phase
Hormone Receptor Positive Breast Cancer Drug: faslodex 500mg Drug: arimidex 1mg Drug: faslodex dummy Drug: arimidex dummy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg With Anastrozole (ARIMIDEX) 1 mg as Hormonal Treatment for Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal Therapy.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Comparison of Progression Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole [ Time Frame: Baseline RECIST 1.1 assessments and then every 12 weeks until the earliest of disease progression evident, patient dies or has surgery/radiotherapy for their disease. ]
    PFS was defined as the time from randomisation until objective disease progression according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1), surgery or radiotherapy to manage worsening of disease or death by any cause (in the absence of progression). Outcome measure is reported as median time from randomisation to PFS, calculated using the Kaplan-Meier technique.


Secondary Outcome Measures:
  • Comparison of Overall Survival (OS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole; Percentage of Patients With Events [ Time Frame: Baseline up to data cut-off for PFS analysis. Following disease progression, patients were to be contacted at 12 weekly intervals to to determine survival status. ]
    OS was defined as the time from randomisation until death by any cause. Two timepoints were planned for OS analysis: an interim OS analysis at the time of the data cut-off for PFS analysis and a final OS analysis when 50% of the deaths have occurred. The current OS data correspond to that of the interim analysis only and the outcome measure is reported as percentage of patients with events.

  • Objective Response Rate (ORR) for Fulvestrant Treatment Versus Anastrozole Treatment [ Time Frame: Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation. ]
    ORR was defined as the percentage patients with an objective response (i.e. those recording a partial response [PR] or complete response [CR]) at some point during the study, prior to disease progression. ORR was assessed in patients with measurable disease at baseline only. The determination of measurable disease at baseline was done using baseline RECIST data.

  • Duration of Response (DoR) for Fulvestrant Treatment Versus Anastrozole Treatment [ Time Frame: Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation. ]
    DoR was defined only for patients who had an objective response, as the time in days from date of first documentation of response (CR/PR) until date of disease progression.

  • Expected Duration of Response (EDoR) for Fulvestrant Treatment Versus Anastrozole Treatment [ Time Frame: Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation. ]
    EDoR was estimated using the formula EDoR = p Efp(x), where x = DoR, p = proportion of responders, and Efp(x) = mean duration of response for responders. The estimation was completed by using the maximum likelihood estimates of p and Efp(x), as described by Ellis (Ellis S et al. Analysis of duration of response in oncology trials, Contemp Clin Trials 2008; 29:456-65).

  • Clinical Benefit Rate (CBR) for Fulvestrant Treatment Versus Anastrozole Treatment [ Time Frame: Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation. ]
    CBR was defined as the percentage of patients who had a clinical benefit (i.e. best objective response of CR, PR or stable disease), that was maintained for at least 24 weeks, prior to any evidence of progression. Note that a minimum duration of 22 weeks for CBR was applicable in the analysis (rather than 24 weeks) to allow for the protocolled window of +/-2 weeks.

  • Duration of Clinical Benefit (DoCB) for Fulvestrant Treatment Versus Anastrozole Treatment [ Time Frame: Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation. ]
    DoCB was defined only for patients who had clinical benefit, as the time in days from date of randomisation until the date of disease progression.

  • Expected Duration of Clinical Benefit (EDoCB) for Fulvestrant Treatment Versus Anastrozole Treatment [ Time Frame: Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation. ]
    EDoCB was estimated using the formula EDoCB = p Efp(x), where x = EDoCB, p = proportion of responders, and Efp(x) = mean duration of response for responders. The estimation was completed by using the maximum likelihood estimates of p and Efp(x), as described by Ellis (Ellis S et al. Analysis of duration of response in oncology trials, Contemp Clin Trials 2008; 29:456-65).

  • Comparison of the Effect of Fulvestrant Treatment Versus Anastrozole Treatment on Time to Deterioration of Health Related Quality of Life (HRQoL) [ Time Frame: Quality of life questionnaires completed at baseline and then every 12 weeks until disease progression or treatment discontinuation. ]
    The Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire was the instrument selected to assess HRQoL and comprises the following subscales: physical well-being (PWB), functional well-being (FWB), social well-being, emotional well-being, and breast cancer subscale (BCS). The main outcome measure from the FACT-B questionnaire was the Trial Outcome Index (TOI), which was a summary of the following subscales: PWB, FWB, and BCS. Outcome measure is reported as median time to deterioration, defined as the interval from the date of randomisation to the first assessment of worsened without an improvement in the next 12 weeks in FACT-B TOI, or the date of death (by any cause in the absence of symptom deterioration). Time to deterioration as measured by FACT-B total score was derived similarly and is also reported.


Enrollment: 524
Actual Study Start Date: October 17, 2012
Estimated Study Completion Date: February 12, 2018
Primary Completion Date: April 11, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: faslodex+placebo
Blinded: Fulvestrant 500mg intramuscular injection (2x250mg) plus dummy Anastrozole tablets
Drug: faslodex 500mg
2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter
Drug: arimidex dummy
oral tablet 1 daily
Active Comparator: arimidex +placebo
Blinded: Anastrozole 1mg tablets plus dummy Fulvestrant intramuscular injection (2x0mg)
Drug: arimidex 1mg
oral tablet 1 daily
Drug: faslodex dummy
2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter

Detailed Description:
A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg with Anastrozole (ARIMIDEX) 1 mg as Hormonal Treatment for Postmenopausal Women with Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal Therapy.
  Eligibility

Ages Eligible for Study:   18 Years to 130 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological confirmation of breast cancer in post menopausal women (age >=60). Positive hormone receptor status (ER +ve and/or PgR +ve) of primary or metastatic tumour tissue based on local laboratory assessment.
  • EITHER locally advanced disease (1 line of chemotherapy allowed only if remain unsuitable for therapy of curative intent) OR Metastatic disease. (1 line of chemotherapy for breast cancer allowed only if subsequent evidence of further progressive disease)
  • At least 1 lesion (measurable and/or non-measurable) that can be accurately assessed at baseline and is suitable for repeated assessment.
  • Postmenopausal women, fulfilling 1 of:

    • Prior bilateral oophorectomy
    • Age >60 years
    • Age < 60 years and amenorrheic for 12+months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and FSH and oestradiol in the postmenopausal range

Exclusion Criteria:

  • Presence of life-threatening metastatic disease
  • Any of:

    • Extensive hepatic involvement
    • involving brain or meninges
    • symptomatic pulmonary lymph spread
  • Discrete lung metastases are acceptable if respiratory function is not significantly compromised
  • Prior systemic therapy for breast cancer other than one line of cytotoxic chemotherapy (the last dose of chemotherapy must have been received more than 28 days prior to randomisation)
  • Radiation therapy if not completed within 28 days prior to randomisation (with the exception of radiotherapy given for control of bone pain, started prior to randomisation). Prior hormonal treatment for breast cancer.
  • Current or prior malignancy within previous 3 years (other than breast cancer or adequately treated basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix).
  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: NCT01602380

  Show 100 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Mehdi Fazal, MD AstraZeneca
Principal Investigator: John Robertson, MD Graduate Medicine and Health School, University of Nottingham, UK
Principal Investigator: Matthew Ellis, DM Washington University School of Medicine, USA
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01602380     History of Changes
Other Study ID Numbers: D699BC00001
Study First Received: May 11, 2012
Results First Received: March 23, 2017
Last Updated: April 7, 2017

Keywords provided by AstraZeneca:
hormone receptor positive breast cancer
endocrine
no hormone therapy
hormone
breast
cancer
neoplasm
metastatic
tumour

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Estradiol
Fulvestrant
Anastrozole
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Estrogens
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 23, 2017