FALCO

Phase 3

Completed

• Conditions: Hormone Receptor Positive Breast Cancer

• Registration Number: JPRN-jRCT1080221957
• Lead Sponsor: AstraZeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: Female
• Target Recruitment: Not specified

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.
- Eithere 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
- 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 of life-threatening metastatic disease
- 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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified