Efficacy and Safety of Letrozole vs. Letrozole Plus Zoledronic Acid as Endocrine Therapy Before Surgery in Postmenopausal Patients With Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: Letrozole; Zolendronic Acid
Intervention description: 2.5 mg.tablet.; 4 mg or an adjusted dose based on renal function in 100 ml physiologic (o.9%) normal saline, (as an intravenous infusion over no less than 15 minutes)
Intervention MeSH terms: Letrozole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Open-label, multicenter, randomized
Enrollment: 168.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast cancer; Anti tumor potential; Letrozole; Zoledronic acid; Neoadjuvant treatment; Hormone responsive breast cancer

Summary:

      This study will evaluate the safety/efficacy of zoledronic acid when given by intravenous
      infusion every 4 weeks in addition to letrozole as endocrine therapy in postmenopausal
      patients with hormone responsive breast cancer
    

Eligibility criteria:

        Inclusion criteria:

          -  Postmenopausal women with primary invasive breast cancer, histologically confirmed by
             core needle biopsy, whose tumors are estrogen (ER) and / or progesterone (PgR)
             positive

          -  Clinical Stage T1c (Size ≥ 1.5 cm), T2, T3, T4a, b, c, N0 or N1, M0 (TNM
             Classification). According to the modified RECIST criteria, tumors of size ≥ 1.5 cm
             are considered measurable by mammography and can be determined as target lesions).

          -  Tumor measurable by mammography, sonography and clinical examination.

          -  Adequate bone marrow, renal and hepatic function

          -  Good health status (ECOG Performance status of 0, 1 or 2)

        Exclusion criteria:

          -  Prior treatment with letrozole or bisphosphonates. 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.

          -  Patients with unstable angina, or uncontrolled cardiac disease (e.g. Class III and IV
             New York Heart Association's Functional Classification, see Appendix 9) or
             uncontrolled endocrine disorders.

          -  Evidence of inflammatory breast cancer or distant metastasis.

          -  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. Recent (within 6 weeks) or planned dental or jaw surgery (e.g.
             extraction, implants).

          -  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

        Other protocol-defined inclusion/exclusion criteria may apply