Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Active	18 and over	Pharmaceutical / Industry	CZOL446GDE21 NCT00375505

Trial Description

Summary

This study examines the safety and efficacy of zoledronic acid 4 mg., given every 3 months over 24 months (infusion at month 0, 3, 6, 9, 12, 15, 18 and 21) in improving bone mineral density in premenopausal women with hormone receptor negative breast cancer and adjuvant chemotherapeutic treatment

Eligibility Criteria

Inclusion Criteria

• Female patients with histologically confirmed incident invasive breast cancer (T1-4) with positive hormone receptor status (ER and/or PgR positive) and no evidence of regional lymph node metastasis (N0) or distant metastasis (M0)

• Patient has undergone complete primary tumor resection and axillary lymph node dissection less than 90 days before start of study drug treatment.

• Patient is premenopausal at diagnosis of breast cancer (spontaneous and regular menses with premenopausal estradiol levels (>10 ng/dL)

• Patient receives adjuvant standard chemoendocrine or endocrine therapy

• Bone density at study entry > -2.5 T-Score

Exclusion Criteria

• History of treatment or disease affecting bone metabolism (e.g., Paget's disease, primary hyperparathyroidism), prior treatment with bisphosphonates or treatments for osteoporosis in addition to calcium and vitamin D

• Abnormal renal function

• 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)

• Pregnancy or lactation

• Women of childbearing potential not applying a medically recognized form of contraception (i.e., oral contraceptives or implants, IUD, vaginal diaphragm or sponge, or condom with spermicide)

Other protocol-defined inclusion/exclusion criteria may apply

Trial Contact Information

Trial Lead Organizations/Sponsors

Novartis Pharmaceuticals Corporation

Novartis

Study Chair

Novartis

Ph: 41 61 324 1111

Germany
	Marburg
	Study Site
		Novartis	Ph: 41 61 324 1111

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00375505
Information obtained from ClinicalTrials.gov on March 18, 2009