Skip to main content
OpenTrials
Completed

NCT Number: NCT00242203

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasm Metastasis Neoplasm Micrometastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zometa

Drug

Other names: Zoledronic acid

Epirubicin

Drug

Other names: Ellence

docetaxel

Drug

Other names: Taxotere

Trastuzumab

Drug

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

Other names: Herceptin

External beam radiation

Radiation

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

Procedure

Primary outcomes

  1. Evaluate the impact of Zometa (zoledronic acid) on the clearance of bone marrow micrometastases

    Time frame: Prior to therapy initiation, after completion of neoadjuvant chemotherapy, and 12-15 months from registration

  2. Evaluate the protective effect of Zometa (zoledronic acid) on chemotherapy-induced loss of bone mineral density

    Time frame: Prior to therapy initiation and 12-15 months from registration

Secondary outcomes

  1. Impact of Zometa (zoledronic acid) on time and site of relapse

    Time frame: 5 years from registration

  2. Effect of treatment on quality of life in women undergoing treatment for LABC.

    Time frame: Baseline and 12-15 months from registration

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Novartis
  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2007
Study completion
2011
First posted
Oct 19, 2005
Registry last updated
Aug 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.