Clinical trial NCT00066807
Conditions: Breast Cancer
Keywords: stage IIIA breast cancer stage I breast cancer stage II breast cancer
Sponsor: ETOP IBCSG Partners Foundation
Start date: 2003-08-01; Completion date: 2006-12-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:
OBJECTIVES:

* Compare ovarian function suppression and tamoxifen or exemestane with vs without adjuvant chemotherapy in premenopausal women with endocrine-responsive resected breast cancer.
* Compare the disease-free and overall survival of patients treated with these regimens.
* Compare sites of first treatment failure in patients treated with these regimens.
* Compare the incidence of second nonbreast malignancies in patients treated with these regimens.
* Compare the quality of life, including late side effects of early menopause, of patients treated with these regimens.

PLANNED OUTLINE:

This is a randomized, multicenter study. Patients are stratified according to participating center, number of positive axillary and/or internal mammary lymph nodes (0 vs 1 or more), method of ovarian function suppression (triptorelin vs oophorectomy vs ovarian irradiation), chemotherapy if randomized to arm II (not containing vs containing an anthracycline or taxane), and endocrine agent (tamoxifen vs exemestane vs selected by subsequent randomization in the TEXT trial). Treatment duration is five years.

Quality of life is assessed at baseline, every 6 months for 2 years, and then annually for 4 years. Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter.

NOTE: Trial was terminated early due to poor accrual.

Arms: arm 1: Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years. arm 2: Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
Interventions: intervention 1: chemotherapy intervention 2: exemestane intervention 3: tamoxifen intervention 4: triptorelin intervention 5: oophorectomy intervention 6: ovarian irradiation
Intervention descriptions: intervention 1: Planned duration of chemotherapy: 2 months if an anthracycline is included (e.g., 4 cycles of EC or AC) or 4 months if no anthracycline is given (e.g., 6 cycles of CMF) is recommended. Unless medically contraindicated, an anthracycline-containing regimen using epirubicin should be given. intervention 2: Exemestane 25 mg orally daily for until 5 years from date of randomization, unless relapse or intolerance should occur earlier. intervention 3: Tamoxifen 20 mg orally daily until 5 years from date of randomization, unless relapse or intolerance should occur earlier. intervention 4: Triptorelin (GnRH analogue) 3.75 mg by intramuscular injection every 28 days for 5 years from randomization, unless relapse or intolerance should occur earlier or surgical oophorectomy or ovarian irradiation is subsequently performed. intervention 5: Bilateral surgical oophorectomy via laparotomy or laparoscopy. intervention 6: Bilateral ovarian irradiation.

Protocol documents: