A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer.
Condition: Hormone Receptor Positive Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: faslodex 500mg; arimidex 1mg; faslodex dummy; arimidex dummy
Intervention description: 2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter; oral tablet 1 daily; 2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter; oral tablet 1 daily
Intervention MeSH terms: Fulvestrant; Anastrozole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 462.0
Sex: Female
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: hormone receptor positive breast cancer; endocrine; no hormone therapy; hormone; breast; cancer; neoplasm; metastatic; tumour

Summary:

      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.
    

Eligibility 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).