A global study to compare the effects of Fulvestrant and arimidex in a subset of patients with breast cancer. - FALCON

Study identifier:D699BC00001

ClinicalTrials.gov identifier:NCT01602380

EudraCT identifier:2011-006326-24

CTIS identifier:N/A

Recruitment Complete

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.

Medical condition

hormone receptor positive breast cancer

Phase

Phase 3

Healthy volunteers

Study drug

faslodex 500mg, arimidex 1mg, faslodex dummy, arimidex dummy

Sex

Female

Actual Enrollment

462

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 17 Oct 2012

Primary Completion Date: 11 Apr 2016

Estimated Study Completion Date: 31 Dec 2024

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2024 by AstraZeneca

Collaborators

Inclusion and exclusion 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).

No locations available

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

Documents available

CSP redacted
Download
SAP redacted
Download
CSR Synopsis redacted
Download
FALCON_Clinical_Study_Protocol
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Contact Backup

In US and Canada - Cancer Study Locator Service (web link - www.emergingmed.com/networks/AstraZeneca)

1-877-400-4656

[email protected]

Investigators

Principal Investigator

Shankar S

AstraZeneca