E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 <=2. 2. Patients must have T2-T4c any N, M0 breast cancer by clinical staging. Note: Primary tumour must be palpable and measure 2cm by calliper measurements in at least one dimension 3. Patient must be post menopausal verified by: Bilateral surgical oophorectomy or no spontaneous menses >= one year or no menses for < 1 year with FSH and oestrodiol levels in postmenopausal range, according to institutional standards. 4. Patient, as documented by the operating surgeon is clinically staged as one of the following: T4 a-c for whom modified radical mastectomy with negative margins is the goal T 2or T 3 for whom conversion for needing mastectomy to breast conservation is the goal T2 for whom lumpectomy at first attempt is the goal. 5. Patient has an ER+ tumour with an Allred score of 6,7or 8 6. Patients must have a mammogram and ultrasound within 42 days prior to registration. 7. Patients, or legally authorised representative, must sign a study specific informed consent document. NOTE: the signed and dated written consent form must be obtained from the patient prior to the first related study procedure. 8. Patients must provide written authorisation to allow the use and disclosure of their protected health information. NOTE: This may be obtained in either the study specific informed consent or in a separate authorisation form and must be obtained from the patient prior to study pre-registration. 9. If the patient is a cancer survivor, all of the following criteria must be met: -Patient has undergone potentially curative therapy for all prior malignancies, -No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, or non-melonoma skin cancer with no evidence of recurrence), and -Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 12 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 12 |
E.8.9.2 | In all countries concerned by the trial months | 7 |