locally advanced breast cancer MedDRA version: 9.1 Level: LLT Classification code 10057654 Term: Breast cancer female
Conditions
Interventions
Trade Name: FEMARA*30CPR RIV 2,5MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Letrozole
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Trade Name: NAVE
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Pre- or post-menopausal women with histologically proven locally advanced primary breast cancer (cT2-T3-T4 a-c, N0-3c, M0) or local recurrence after breast conserving surgery (rT1-T4a-c, N0-3c, M0) or local recurrence after mastectomy (M1 on the chest wall) or regional recurrence (axillary, supraclavicular and internal mammary chain lymph nodes) -Patients must be suitable for local treatment (surgery and/or radiotherapy) in a multidisciplinary program - ER or PgR 0-49% of the cells and HER2 neg -Measurable and/or evaluable lesions -Age 18 years -ECOG performance status 2 (Karnofsky 60%) -Normal organ and marrow function. -No evidence of distance metastases -Geographically accessible for follow up. -Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation. -Ability to understand and the willingness to sign a written informed consent document. 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: Presence of distant metastases -Presence of HER2/neu overexpression or amplification of HER2/neu gene -Previous or concomitant other malignancy, including, except prior ipsilateral or contralateral invasive breast cancer or synchronous bilateral breast cancer with the same immunohistochemical features, basal or squamous cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix. -Clinical grade greater than or equal to 2 peripheral neuropathy. -Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. -Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects of agents included in this trial. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding must be discontinued.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the activity of 8 courses of primary chemotherapy versus 4 courses of primary chemotherapy in combination with endocrine therapy in terms of Ki-67 expression;Secondary Objective: To describe the efficacy and tolerability of the regimen;Primary end point(s): To assess the activity of 8 courses of primary chemotherapy versus 4 courses of primary chemotherapy in combination with endocrine therapy in terms of Ki-67 expression. | — |
Countries
Italy
Outcome results
None listed