eoadjuvant therapy for postmenopausal women with ER and/or PgR positive breast cancer. A randomized open phase II trial evaluating the efficacy of a 6 months preoperative treatment withLetrozole (2.5 mg/day) with or withoutZoledronic acid (4 mg every 4 weeks). - FEMZONE

• Conditions: Breast cancer by postmenopausal women; MedDRA version: 8.1Level: PTClassification code 10057654

• Registration Number: EUCTR2004-004007-37-DE
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-02
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

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 <= 55 but no spontaneous menses for at least 1 year.
- Age <= 55 and spontaneous menses within the past year, but currently amenorrheic (e.g., spontaneous or secondary to hysterectomy), and with postmenopausal gonadotrophin levels (luteinizing hormone and follicle stimulating hormone levels) >40 IU/L or postmenopausal estradiol levels <5 ng/dL or according to the definition of postmenopausal range” for the laboratory involved.
- Bilateral oophorectomy (prior to the diagnosis of breast cancer).
4. Tumor measurable by mammography, sonography and clinical examination.
5. Adequate renal function (see exclusion criterion 4).
6. Adequate bone marrow function (WBC >=3.5 G/L and platelets >=100.0 G/L, and hemoglobin >11.0 g/dL).
7. Documented evidence of adequate hepatic function (bilirubin <25 mcmol/L, AST (SGOT) <60 U/L).
8. A life expectancy of at least 12 months.
9. ECOG Performance status of 0, 1 or 2.
10. Patients should be assessable for Follow-up.
11. Written informed consent.

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified