EXEMESTANE for Breast cancer | Endocrine-responsive early breast cancer

Inclusion criteria

• {"criterion_text":"- Women with histological diagnosis of invasive breast cancer completely removed by surgery, any T, any N."}
• {"criterion_text":"- Postmenopausal status defined by at least one of the following conditions: 1. Aged = 60 2. Aged 45-59 and satisfying one or more of the following criteria • amenorrhea for =12 months and intact uterus; • amenorrhea for <12 months and FSH within the postmenopausal range, including: > pts with hysterectomy > pts who have received HRT > pts with chemotherapy-induced amenorrhea 3. bilateral oophorectomy at any age >18 years."}
• {"criterion_text":"- Primary tumor positive for ER and/or PgR (=1% tumor cells positive by immunohistochemistry or = 10 fmol/mg cytosol protein by ligand binding assay)."}
• {"criterion_text":"- Patients who are prescribed 5 years of endocrine therapy with an AI"}
• {"criterion_text":"- Indication for adjuvant chemotherapy- Patients with HER-2 positive tumors are eligible provided that they are prescribed trastuzumab according to registered schedule."}
• {"criterion_text":"- Signed informed consent."}

Exclusion criteria

• {"criterion_text":"- HRT currently assumed or during the month before randomization"}
• {"criterion_text":"- Recurrent or metastatic disease"}
• {"criterion_text":"- HER-2 positive tumors if treatment with trastuzumab is considered not appropriate/feasible"}
• {"criterion_text":"- Concurrent illness that contraindicate adjuvant endocrine treatment and/or chemotherapy"}
• {"criterion_text":"- Patients who have received TAM as part of any breast cancer prevention trial"}
• {"criterion_text":"- Previous history of invasive breast cancer or other invasive malignancy within the previous 10 years, other than squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied"}
• {"criterion_text":"- Concomitant severe disease which would place the patient at unusual risk"}
• {"criterion_text":"- Concurrent treatment with experimental drugs"}
• {"criterion_text":"- Patients treated with systemic investigational drugs within the past 30 days"}

Primary endpoints

• {"endpoint_text":"- According to the STEEP system (Hudis et al. J Clin Oncol 2007; 25:2127-2132) the primary endpoint will be the so called DFS, defined as time elapsing between the date of randomization and the date of one of the following events, whichever occurs first - Local Recurrence of disease - Regional recurrence of disease - Distant recurrence of disease - Contralateral invasive or intraductal breast cancer - Second primary malignancy other than breast - Death for any cause","definition_or_measurement_approach":"DFS defined according to the STEEP system as time from randomization to first of: local recurrence, regional recurrence, distant recurrence, contralateral invasive or intraductal breast cancer, second primary malignancy other than breast, or death from any cause."}

Secondary endpoints

• {"endpoint_text":"- the OS defined as time elapsing between the date of randomization and the date of death for any cause","definition_or_measurement_approach":"Overall survival (OS) defined as time from randomization to death for any cause."}
• {"endpoint_text":"- all the other outcomes defined within the STEEP system","definition_or_measurement_approach":""}
• {"endpoint_text":"- safety: clinical and laboratory toxicities will be graded according to NCI criteria CTCAE","definition_or_measurement_approach":"Safety assessed by clinical and laboratory toxicities graded according to NCI CTCAE criteria."}

Italy

Earliest CTIS Part Ii Submission Date

03-12-2024

Latest Decision Or Authorization Date

03-02-2025

Processing Time Days

62

Number Of Participants

1014

Primary sponsor

Full Name

IRCCS Ospedale Policlinico San Martino

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy