| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN99515843 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | C/15/00 |
| Public title | A Randomised Trial of Sequential Aromatase Inhibitors (AI) in Postmenopausal Women with Locally Advanced or Metastatic Breast Cancer. The SAINT Trial |
| Scientific title |
|
| Acronym | SAINT |
| Disease/condition/study domain | Breast |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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). |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | International Collaborative Cancer Group |
| Sponsor name | International Collaborative Cancer Group (ICGG), London, UK |
| Sponsor details | Medical Oncology
Charing Cross Hospital
Fulham Palace Road
London
United Kingdom
SW6 |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN99515843 |
| Date last extracted from ISRCTN register | 17/04/2008 |
