Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
18/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

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

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

Sponsor information

Organisation

International Collaborative Cancer Group (ICGG) (UK)

Sponsor details

Medical Oncology
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Sponsor type

Research organisation

Website

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

Publication citations

Additional files

Editorial Notes

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