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A Phase III Trial Evaluating the Role of Exemestane Plus GnRH analogue as Adjuvant Therapy for Premenopausal Women with endocrine Responsive Breast Cancer

Patient Population

Premenopausal women with histologically proven, resected breast cancer with
ER and/or PgR positive tumors.

Entry

Patients should bei radomized within 12 weeks after surgery prior to commencing any adjuvant systemictherapy.

Stratification Factors:

• Institution
• Adjuvant 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) 

 

1845 patients (410 per year for 4.5 years with 2.4 years of additional follow-up)

Treatment Schedules

Radiationtherapy 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:

Chemotherapy

Patients in the chemotherapy stratum should commence chemotherapy after
randomization at the same time as GnRH analogue. A planned duration of ≥ 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. If an
anthracycline is used, an epirubicin-containing regimen is recommended.

Adjuvant Endocrine Therapy:

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.

Tamoxifen:

Tamoxifen 20 mg orally daily until 5 years from date of randomization, unless
relapse or intolerance should occur earlier. Tamoxifen should start after adjuvant
chemotherapy has been completed or approximately six weeks to eight weeks
after the initiation of GnRH analogue, whichever is later.

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 start after adjuvant chemotherapy has been completed or
approximately six to eight weeks after the initiation of GnRH analogue,
whichever is later.Triptorelin:

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