Breast cancer by postmenopausal women MedDRA version: 8.1 Level: PT Classification code 10057654
Conditions
Interventions
Trade Name: Femara 2,5 mg
Product Name: Femara
Pharmaceutical Form: Tablet
INN or Proposed INN: Letrozole
CAS Number: n.a.
Current Sponsor code: CGS 20267
Concentration unit: mg milligram(s)
Concentra
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Postmenopausal women able to comply with the protocol requirements with primary invasive breast cancer, histologically confirmed by core needle biopsy, whose tumors are estrogen (ER) and / or progesterone (PgR) positive, defined by core biopsy immunohistochemistry with > 10% positive malignant epithelial cells. 2. Clinical Stage T1c (Size >= 1.5 cm), T2, T3, T4a, b, c, N0 or N1, M0 3. Post menopausal status defined by one of the following: - Age >55 years. - Age 40 IU/L or postmenopausal estradiol levels =3.5 G/L and platelets >=100.0 G/L, and hemoglobin >11.0 g/dL). 7. Documented evidence of adequate hepatic function (bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Prior treatment with letrozole or bisphosphonates. 2. Patients with unstable angina, or uncontrolled cardiac disease or uncontrolled endocrine disorders. 3. Evidence of inflammatory breast cancer or distant metastasis. 4. Abnormal renal function as evidenced by a calculated creatinine clearance <30 mL/minute. 5. Other concurrent malignant disease with the exception of cone-biopsied in situ carcinoma of the cervix uteri, or adequately treated basal or squamous cell carcinoma of the skin, or other curable cancers e.g. Hodgkin’s disease or non-Hodgkin-lymphoma, provided 5 years have elapsed from completion of therapy, and there has been no recurrence. 6. Prior and concomitant anti-breast-cancer treatments such as chemotherapy, immunotherapy / biological response modifiers (BRM’s), endocrine therapy other than letrozole (including steroids), and radiotherapy. Patients who have received hormone replacement therapy (HRT) will NOT be excluded, provided that HRT is discontinued at least 2 weeks prior to entry into the study. 7. Concomitant treatment with systemic steroids, except for topical applications (e.g. for rash), inhaled sprays (e.g. for obstructive airways diseases), eye drops or local injections (e.g. intra-articular). 8. Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures. 9. Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants). 10. History of diseases with influence on bone metabolism, such as Paget’s disease, Osteogenesis Imperfecta, and primary or secondary hyperthyroidism within the 12 months prior to study entry. 11. Known hypersensitivity to zoledronic acid, other bisphosphonates or letrozole. 12. Other investigational drugs within the past 30 days and the concomitant use of investigational drugs. 13. History of non-compliance to medical regimens and patients who are considered potentially unreliable. 14. Unstable or serious co-existing medical condition, including potentially serious infection that would make the patient inappropriate for study participation, or any serious medical or psychiatric disorder that would interfere with the patient’s safety or informed consent. (No specific tests are required for confirmation of egilibility). 15. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective of the study is to demonstrate superiority of letrozole and zoledronic acid over letrozole monotherapy given as 6 months preoperative treatment with respect to tumor response. Response is defined as complete response (CR) or partial response (PR) based on mammography and/or sonography according to modified RECIST criteria at month 6.;Secondary Objective: - To compare best response based on mammography and/or sonography according to modified RECIST during 6 months of neoadjuvant treatment. - To compare the number of patients that qualify for breast-conserving surgery rather than mastectomy. - To compare pathologic complete response (pCR). - To compare the change in tumor size. - To compare BC deaths and overall survival. - To compare the Quality of Life using the FACT-B questionnaire. - To compare apoptosis (only in patients who take part in the apoptosis substudy) - To describe the tumor response in subgroups of patients with polymorphism and special gene expression. - To compare the safety and tolerability.;Primary end point(s): Tumor response after 6 month of treatment according to modified RECIST criteria. | — |
Countries
Germany
Outcome results
None listed