drugset / Trial / NCT00066807
Premenopausal Endocrine Responsive Chemotherapy Trial
Phase 3
Terminated
29 enrolled
ETOP IBCSG Partners Foundation
Breast International Group · collabNational Cancer Institute (NCI) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The PERCHE trial evaluated the worth of adding adjuvant chemotherapy for premenopausal women with steroid hormone receptor positive early invasive breast cancer who receive ovarian function suppression plus either tamoxifen or exemestane for five years. The use of chemotherapy was determined by randomization. The method of ovarian function suppression (GnRH analogue for five years, surgical oophorectomy or ovarian irradiation) and the choice of tamoxifen or exemestane were determined by the investigator or by randomization in the IBCSG 25-02 TEXT trial \[recommended option\]. The trial was terminated early due to poor accrual.
Timeline
- Start
- 2003-08
- Primary completion
- 2006-12
- Completion
- 2006-12
Publications
- Background Francis P, Fleming G, Nasi ML, et al.: Tailored treatment investigations for premenopausal women with endocrine responsive (ER+ and/or PGR+) breast cancer: the SOFT, TEXT, and PERCHE trials. [Abstract] The Breast 12 (Suppl 1): A-P104, S44, 2003.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Epirubicin | Small molecule | — | — |
| Subject | Exemestane | Small molecule | 25 mg | Oral |
| Subject | Tamoxifen | Small molecule | 20 mg | Oral |
| Subject | Triptorelin | Other / unclassified | 3.75 mg | Intramuscular |