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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.


Phase 3
N/A
N/A
Open (Enrolling)
Female
Hormone Receptor Positive Breast Cancer

Thank you

Trial Information

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.


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.


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).

Type of Study:

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

Outcome Measure:

Compare the progression free survival (PFS) in patients treated with Fulvestrant with those treated with Anastrozole.

Outcome 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.

Safety Issue:

No

Principal Investigator

Yuri E Rukazenkov, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Argentina: Human Research Bioethics Committee

Study ID:

D699BC00001

NCT ID:

NCT01602380

Start Date:

October 2012

Completion Date:

September 2017

Related Keywords:

  • Hormone Receptor Positive Breast Cancer
  • hormone receptor positive breast cancer
  • endocrine
  • no hormone therapy
  • hormone
  • breast
  • cancer
  • neoplasm
  • metastatic
  • tumour
  • Breast Neoplasms

Name

Location

Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteBoca Raton, Florida  
Research SiteArlington Heights, Illinois  
Research SiteBangor, Maine  
Research SiteBaltimore, Maryland  
Research SiteBeverly, Massachusetts  
Research SiteBattle Kreek, Michigan  
Research SiteBranson, Missouri  
Research SiteGrand Island, Nebraska  
Research SiteBelleville, New Jersey  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteAkron, Ohio  
Research SiteAbilene, Texas  
Research SiteAbington, Virginia  
Research SiteClarksburg, West Virginia