Evaluation of Chemotherapy Prior to Surgery With or Without Zometa for Women With Locally Advanced Breast Cancer

Impact of Neoadjuvant Chemotherapy With or Without Zometa on Occult Micrometastases and Bone Density in Women With Locally Advanced Breast Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00242203

Enrollment

120

Registered

2005-10-19

Start date

2002-10-31

Completion date

2011-05-31

Last updated

2013-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

Breast Cancer, Neoadjuvant, Micrometastasis

Brief summary

This study is designed to evaluate the impact of Zometa on clearance of bone marrow micrometastases; the protective effect on chemotherapy-induced loss of bone mineral density; and quality of life in women undergoing treatment for locally advanced breast cancer.

Interventions

RADIATIONExternal beam radiation

PROCEDUREModified radical mastectomy or breast conserving surgery with axillary lymph node dissection

DRUGEpirubicin

DRUGDocetaxel

DRUGTrastuzumab

ONLY for patients that are Her-2 overexpressing by 3+ by ICH for FSH

DRUGZometa

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Newly diagnosed primary invasive ductal or invasive lobular breast adenocarcinoma * Tumor classified as clinically large T2 (2-5 cm), T3, T4 or any T with N1, N2 * Prior malignancies: limited to curatively treated basal or squamous carcinoma of the skin or history of previous malignancies, treated and now \> 5 years disease free * \>= 18 years of age * Normal left ventricular function by echocardiogram or radioventriculogram * Karnofsky Performance \>= 70

Exclusion criteria

* No evidence of distant metastasis present by CT, Bone scan, or physical exam * If the bone scan or CT scans demonstrate indeterminate lesions, the nature of these lesions may be further clarified by additional testing such as PET or MRI * No current treatment with Zometa or other bisphosphonates * No serious functional disorders of the liver or kidneys: * Serum Creatinine \<=2 * ALT/AST/ALK Phos \<= 1.5 x upper limit of institutional normal. * Bili \<= 1.5 x upper limit of institutional normal. * Currently not pregnant

Design outcomes

Primary

Measure	Time frame
Evaluate the impact of Zometa (zoledronic acid) on the clearance of bone marrow micrometastases	Prior to therapy initiation, after completion of neoadjuvant chemotherapy, and 12-15 months from registration
Evaluate the protective effect of Zometa (zoledronic acid) on chemotherapy-induced loss of bone mineral density	Prior to therapy initiation and 12-15 months from registration

Secondary

Measure	Time frame
Impact of Zometa (zoledronic acid) on time and site of relapse	5 years from registration
Effect of treatment on quality of life in women undergoing treatment for LABC.	Baseline and 12-15 months from registration

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026