Plain English Summary
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
C/15/00
Study information
Scientific title
A randomised trial of sequential aromatase inhibitors (AI) in postmenopausal women with locally advanced or metastatic breast cancer
Acronym
SAINT
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Breast cancer
Intervention
In the experimental arms of the study (A1 and A2) patients will initially receive a second generation AI (in the form of Formestane, 250 mg im 2-weekly) followed at disease progression by a third generation AI, which by randomisation will be either (A1) non steroidal (Anastrazole 1 mg po daily) or (A2) steroidal (Exemestane 25 mg po daily).
Patients in the control arms of the study (B1 and B2) will receive immediate Anastrazole 1 mg po daily (B1) or Exemestane 25 mg po daily (B2).
Intervention type
Drug
Phase
Not Applicable
Drug names
Formestane, anastrazole, exemestane
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2001
Overall trial end date
31/12/2004
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with positive estrogen receptor (ER) and/or progesterone receptor (PgR) status
2. Postmenopausal
3. Measurable or accessible locally advanced, unresectable or locoregionally recurrent or metastatic breast carcinoma with documented disease progression
4. At least one bidimensionally measurable lesion should be available for assessment
5. Patients would have failed to respond to previous first line treatment with anti-oestrogens
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2001
Recruitment end date
31/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Funders
Funder type
Research organisation
Funder name
International Collaborative Cancer Group (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary