Premenopausal Endocrine Responsive Chemotherapy Trial
- Conditions
- Breast Cancer
- Interventions
- Drug: chemotherapyProcedure: oophorectomyProcedure: ovarian irradiation
- Registration Number
- NCT00066807
- Lead Sponsor
- ETOP IBCSG Partners Foundation
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 29
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OFS plus T or E tamoxifen Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years. Chemotherapy plus OFS plus T or E chemotherapy 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. OFS plus T or E ovarian irradiation Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years. OFS plus T or E triptorelin Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years. OFS plus T or E oophorectomy Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years. Chemotherapy plus OFS plus T or E triptorelin 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. Chemotherapy plus OFS plus T or E oophorectomy 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. Chemotherapy plus OFS plus T or E ovarian irradiation 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. OFS plus T or E exemestane Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years. Chemotherapy plus OFS plus T or E exemestane 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. Chemotherapy plus OFS plus T or E tamoxifen 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.
- Primary Outcome Measures
Name Time Method Disease-free Survival For first time at a median follow up approximately 5 years
- Secondary Outcome Measures
Name Time Method Systemic Disease-free Survival For first time at a median follow up approximately 5 years Overall Survival For first time at a median follow up approximately 5 years Sites of First Treatment Failure For first time at a median follow up approximately 5 years
Trial Locations
- Locations (6)
Centre Hospitalier Universitaire Vaudois
🇨🇭Lausanne, Switzerland
Kantonsspital - St. Gallen
🇨🇭St. Gallen, Switzerland
Centro di Riferimento Oncologico - Aviano
🇮🇹Aviano, Italy
National Institute of Oncology
🇭🇺Budapest, Hungary
Kantonsspital Graubuenden
🇨🇭Chur, Switzerland
European Institute of Oncology
🇮🇹Milan, Italy