Breast Cancer
Conditions
Interventions
Product Name: Anastrozole
Pharmaceutical Form: Tablet
Product Name: Letrozole
Pharmaceutical Form: Tablet
Product Name: Exemestane
Pharmaceutical Form: Tablet
Sponsors
ACOSOG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient will be eligible for inclusion in this study only if all the following criteria apply: 1. The patients must have an EOC/Zubrod performance status of = one year or no menses for =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A patient will not be eligible for inclusion in this study only if all the following criteria apply: 1. Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumour or peau d’orange without erythema) 2. Prior treatment for breast cancer, including radiation, endocrine therapy, chemotherapy or investigational agent. 3. Patient has received hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration. 4. Patient has distant metastases (M1) excluding isolated ipsilateral supraclavicular node involvement 5. Patient does not agree to undergo mastectomy or lumpectomy after neoadjuvant aromatase inhibitor therapy 6. Patient is enrolled in another neoadjuvant clinical trial for treatment of the existing breast cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): ;Main Objective: The primary objective is to determine whether anastrozole, exemestane or Letrozole administered for 16 to 18 weeks as neoadjuvant endocrine therapy for post menopausal patients with stage II or III ER+ breast cancer should be chosen as the aromatase inhibitor arm of a future study that will compare neoadjuvant aromatase inhibitor treatment with neoadjuvant chemotherapy.;Secondary Objective: Secondary Objectives: 1. To compare the neoadjuvant treatment regimens relative to the rates of improvement in surgical outcome defined as follows: For T4 a,b,c tumours: mastectomy with primary skin closure and negative surgical margins. For T3 tumours and T2 tumours classified as requiring a mastectomy at baseline: breast conserving surgery with negative final margins. For T2 tumours classified as potential candidates for breast conservation: breast conserving surgery at first attempt. | — |
Countries
Ireland
Outcome results
None listed