English Summary - SOFT
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A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women with Endocrine Responsive Breast Cancer
Patient Population
Premenopausal women (estradiol (E2) levels in the premenopausal range) with histologically proven, resected breast cancer with ER and/or PgR positive tumors who have received either no chemotherapy or remain premenopausal following completion of adjuvant and/or neoadjuvant chemotherapy.
Entry
Patients who do not receive chemotherapy should be randomized within 12 weeks after surgery; such patients must have estradiol (E2) levels in the premenopausal range following surgery. Patients who have received adjuvant and/or neoadjuvant chemotherapy should be randomized within 8 months of the final dose of chemotherapy as soon as premenopausal status is confirmed; such patients must have estradiol (E2) levels in the premenopausal range between 2 weeks and 8 months after the final dose of chemotherapy.Stratification Factors:
- Institution
- Prior adjuvant/neoadjuvant chemotherapy (no; yes)
- Number of positive axillary and/or internal mammary lymph nodes (0 - including pN0(sn), pN0(i+)(sn) and pNx; 1 or more - including pN1mi)
- Intended initial method of ovarian function suppression (triptorelin for 5 years; surgical oophorectomy; ovarian irradiation)
Sample Size:
3000 patients (600 per year for 5 years with 1.9 years of additional follow-up)Treatment Schedules
Radiotherapy: Radiation therapy to the conserved breast is required. Radiation therapy to the chest wall following mastectomy is optional (if given, it may also include nodal fields). Radiation therapy may be given either after all chemotherapy or integrated into chemotherapy (if regimen is considered safe by the investigator). Radiation therapy may be concurrent with trial hormonal therapy.
Chemotherapy:
Patients in the chemotherapy stratum must have completed adjuvant (and/or neoadjuvant) chemotherapy prior to randomization. A planned duration of ? 2 months if an anthracycline was included (e.g. 4 cycles of EC or AC) or ? 4 months if no anthracycline was given (e.g. 6 cycles of CMF) is recommended. If an anthracycline was used, an epirubicin-containing regimen is recommended. The final dose of chemotherapy must be less than 8 months prior to randomization.
Adjuvant Endocrine Therapy:
Tamoxifen:
Tamoxifen 20 mg orally daily until 5 years from date of randomization, unless relapse or intolerance should occur earlier.
Exemestane:
Exemestane (Aromasin®) 25 mg orally daily, preferably after food, until 5 years from date of randomization, unless relapse or intolerance should occur earlier. Exemestane should begin after initiating ovarian function suppression.
Triptorelin:
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. Triptorelin (Decapeptyl Depot® intramuscular or Trelstar Depot® intramuscular) will be supplied by the study for use as GnRH analogue.
Surgical oophorectomy:
Bilateral surgical oophorectomy via laparotomy or laparoscopy.
Ovarian irradiation:
Bilateral ovarian irradiation. Biochemical verification of ovarian function cessation is required after two months (see Section 5.1.3).