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

August 9, 2013 updated by: Washington University School of Medicine

Impact of Neoadjuvant Chemotherapy With or Without Zometa on Occult Micrometastases and Bone Density in 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zometa

Zometa 4 mg IV every 3 weeks for a total of 17 doses. The first treatment will be given at the time of the first chemotherapy treatment and will continue for approximately 1 year.

Neoadjuvant therapy

  • Epirubicin 75 mg/m2 IV every 21 days for 4 cycles prior to surgery
  • Docetaxel 75 mg/m2 IV every 21 days for 4 cycles prior to surgery

Surgery - modified radical mastectomy or breast conserving surgery with axillary lymph node dissection

Adjuvant therapy

  • Epirubicin 75 mg/m2 IV every 21 days for 2 cycles
  • Docetaxel 75 mg/m2 IV every 21 days for 2 cycles
  • All patients who are found to be Her-2 overexpressing by 3+ by ICH for FSH will receive trastuzumab 6 mg/kg IV every 3 weeks for 1 year post surgery

Radiation therapy - 50-60 Gy in 1.8-2.0 Gy daily fractions to the breast or chest wall. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks
Drug: Docetaxel
Other Names:
  • Taxotere
Drug: Epirubicin
Other Names:
  • Ellence
Drug: Zometa
Other Names:
  • Zoledronic acid
Drug: Trastuzumab
ONLY for patients that are Her-2 overexpressing by 3+ by ICH for FSH
Other Names:
  • Herceptin
Radiation: External beam radiation
Procedure: Modified radical mastectomy or breast conserving surgery with axillary lymph node dissection
Active Comparator: No Zometa

Neoadjuvant therapy

  • Epirubicin 75 mg/m2 IV every 21 days for 4 cycles prior to surgery
  • Docetaxel 75 mg/m2 IV every 21 days for 4 cycles prior to surgery

Surgery - modified radical mastectomy or breast conserving surgery with axillary lymph node dissection

Adjuvant therapy

  • Epirubicin 75 mg/m2 IV every 21 days for 2 cycles
  • Docetaxel 75 mg/m2 IV every 21 days for 2 cycles
  • All patients who are found to be Her-2 overexpressing by 3+ by ICH for FSH will receive trastuzumab 6 mg/kg IV every 3 weeks for 1 year post surgery

Radiation therapy - 50-60 Gy in 1.8-2.0 Gy daily fractions to the breast or chest wall. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks
Drug: Docetaxel
Other Names:
  • Taxotere
Drug: Epirubicin
Other Names:
  • Ellence
Drug: Trastuzumab
ONLY for patients that are Her-2 overexpressing by 3+ by ICH for FSH
Other Names:
  • Herceptin
Radiation: External beam radiation
Procedure: Modified radical mastectomy or breast conserving surgery with axillary lymph node dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: Prior to therapy initiation and 12-15 months from registration
Prior to therapy initiation and 12-15 months from registration

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Novartis
Pfizer

Investigators

  • Principal Investigator: Rebecca Aft, M.D., Ph.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

October 17, 2005

First Submitted That Met QC Criteria

October 17, 2005

First Posted (Estimate)

October 19, 2005

Study Record Updates

Last Update Posted (Estimate)

August 13, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-0788 / 201104272

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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