Trial record 1 of 1 for:    NCT01602380
Previous Study | Return to List | Next Study

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: August 7, 2014
Last verified: August 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:
  • Compare the 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare the Overall Survival (OS, death due to any cause) in patients treated with Fulvestrant with those treated with Anastrozole when 50% of patients are recorded as having died. [ Time Frame: Following disease progression, patients will be contacted at 12 weekly intervals to determine survival status ] [ Designated as safety issue: No ]
  • Measure objective response rate (ORR) for Fulvestrant treatment versus Anastrozole. (ORR =% of patients recording partial (PR) or complete response (CR). [ Time Frame: Baseline RECIST 1.1 assessments and then every 12 weeks ] [ Designated as safety issue: No ]
  • Measure the duration of response (DoR) for Fulvestrant versus Anastrozole treatment. (DoR = days from PR/CR response to objective disease progression). [ Time Frame: Baseline RECIST 1.1 assessments and then every 12 weeks ] [ Designated as safety issue: No ]
  • Measure expected duration of response (EDoR) for Fulvestrant treatment versus Anastrozole. (EDoR = p Efp(x), where x=DoR, p=proportion of responders, Efp(x) is mean duration of response). [ Time Frame: Baseline RECIST 1.1 assessments and then every 12 weeks ] [ Designated as safety issue: No ]
  • Measure clinical benefit rate (CBR) for Fulvestrant treatment versus Anastrozole. (CBR= proportion of patients recording RECIST assessments of CR/PR or stable disease (SD) over at least 154 days. [ Time Frame: Baseline RECIST 1.1 assessments and then every 12 weeks ] [ Designated as safety issue: No ]
  • Measure the duration of clinical benefit (DoCB) for Fulvestrant versus Anastrozole treatment. (DoCB = for patients recording clinical benefit responses only; days from randomization to date of disease progression). [ Time Frame: Baseline RECIST 1.1 assessments and then every 12 weeks ] [ Designated as safety issue: No ]
  • Measure expected duration of clinical benefit (EDoCB) for Fulvestrant treatment versus Anastrozole. (EDoCB = p Efp(x), where x=DoCB, p=proportion of responders, Efp(x) is mean duration of clinical benefit). [ Time Frame: Baseline RECIST 1.1 assessments and then every 12 weeks ] [ Designated as safety issue: No ]
  • Compare the effect of Fulvestrant treatment versus Anastrozole treatment on Health Related Quality of Life (HRQoL). [ Time Frame: Quality of life questionnaires completed at baseline, 12 weekly whilst on treatment, or 24 weekly for patients being followed for survival ] [ Designated as safety issue: No ]
  • Compare the safety of fulvestrant versus anastrozole treatment by assessing adverse events and vital sign measurements: weight, pulse and blood pressure. [ Time Frame: Up to the primary analysis: Adverse events will be collected from date of consent to 56 days after final injection. Vital signs will be collected at each on-treatment visit and until 35 days after last injection ] [ Designated as safety issue: Yes ]
  • Compare the safety of fulvestrant versus anastrozole treatment by assessing a panel of adverse events measures: electrocardiogram, haematology and clinical chemistry assessments. [ Time Frame: Up to the primary analysis: ECGs, clinical chemistry and haematology will be collected from randomization and every 12 weeks until 35 days after final injection. ] [ Designated as safety issue: Yes ]
  • Compare the safety of fulvestrant versus anastrozole treatment after the primary analysis by continued collection and evaluation of serious adverse events. [ Time Frame: Following the primary analysis, only serious adverse events are recorded up until 56 days after a patient's final injection. ] [ Designated as safety issue: Yes ]

Enrollment: 524
Study Start Date: October 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: January 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 and older
Genders 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 101 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Yuri E Rukazenkov, 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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01602380     History of Changes
Other Study ID Numbers: D699BC00001
Study First Received: May 11, 2012
Last Updated: August 7, 2014
Health Authority: Argentina: Human Research Bioethics Committee
Argentina: Ministry of Health
Brazil: Ministry of Health
Brazil: Ethics Committee
Canada: Ethics Review Committee
Canada: Health Canada
China: Food and Drug Administration
China: Ministry of Health
China: National Natural Science Foundation
Czech Republic: State Institute for Drug Control
Czech Republic: Ethics Committee
India: Drugs Controller General of India
India: Institutional Review Board
Italy: Ethics Committee
Italy: Ministry of Health
Japan: Pharmaceuticals and Medical Devices Agency
Mexico: Ethics Committee
Mexico: Ministry of Health
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Peru: Ministry of Health
Poland: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
ROMANIA: The National Board of Ethics for the Clinical Study of Medicines
Romania: National Agency for Medicines and Medical Devices
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ministry of Health of the Russian Federation
Russia: Ethics Committee
Russia: Pharmacological Committee, Ministry of Health
Slovakia: State Institute for Drug Control
Slovenia: Ethics Committee
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Taiwan: Institutional Review Board
Taiwan: Department of Health
Turkey: Ethics Committee
Turkey: Ministry of Health
Ukraine: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
United States: Food and Drug Administration

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
Anastrozole
Fulvestrant
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists

ClinicalTrials.gov processed this record on September 16, 2014