A randomised trial of sequential aromatase inhibitors (AI) in postmenopausal women with locally advanced or metastatic breast cancer

ISRCTN	ISRCTN99515843
DOI	https://doi.org/10.1186/ISRCTN99515843
Protocol serial number	C/15/00
Sponsor	International Collaborative Cancer Group (ICGG) (UK)
Funder	International Collaborative Cancer Group (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised trial of sequential aromatase inhibitors (AI) in postmenopausal women with locally advanced or metastatic breast cancer
Study acronym	SAINT
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Formestane, anastrazole, exemestane
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2001
Date of final enrolment	31/12/2004

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

18/01/2016: no publications found on PubMed.