FindTrial
Sign In

Phase II study of Exemestane dose intensification (150 mg daily) in postmenopausal patients with advanced breast cancer progressing under standard dose Exe (25 mg daily) given as adjuvant or palliative therapy - ND

Phase II study of Exemestane dose intensification (150 mg daily) in postmenopausal patients with advanced breast cancer progressing under standard dose Exe (25 mg daily) given as adjuvant or palliative therapy - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-004169-25-IT
Enrollment
Unknown
Registered
2009-01-09
Start date
2009-01-19
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastatic breast cancer MedDRA version: 9.1 Level: LLT Classification code 10055113 Term: Breast cancer metastatic

Interventions

Trade Name: AROMASIN*120CPR RIV 25MG Pharmaceutical Form: Tablet INN or Proposed INN: Exemestane Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25-

Sponsors

ISTITUTO EUROPEO DI ONCOLOGIA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Histological diagnosis of breast cancer. Postmenopausal status defined by one of the following: -Patients of any age who have had a bilateral oophorectomy (including radiation castration AND amenorrheic for > 3 months). -Patients 56 years old or older. If the patient has any evidence of ovarian function, biochemical evidence of definite postmenopausal status (defined as estradiol, LH, and FSH in the postmenopausal range) is required. -Patients 55 years old or younger must have biochemical evidence of definite postmenopausal status (defined as estradiol, LH, and FSH in the postmenopausal range. -Patients who have received prior LHRH analogue within the last year are eligible if they have definite evidence of postmenopausal status as defined above. Steroid hormone receptor positive tumours (ER and/or PgR), determined by immunohistochemistry (IHC). Progression on prior treatment with standard doses of E (25 mg/daily) given either as adjuvant or palliative treatment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients who have received an aromatase inhibitor, other than Exemestane 25 mg daily, in the adjuvant setting or for advanced disease Visceral involvement with risk for organ dysfunction.

Design outcomes

Primary

MeasureTime frame
Main Objective: The primary objective is to determine the efficacy of Exemestane dose intensification in postmenopausal women with endocrine responsive advanced breast cancer resistant to standard doses of Exemestane.;Secondary Objective: evaluate the treatment safety profile by recording the adverse drug reactions and a number of selective quality of life features;Primary end point(s): Clinical benefit rate (CBR) (CR + PR + SD ≥ 6 months)—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026