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

NCT00242203

Last updated date
Study Location
Washington University School of Medicine
St. Louis, Missouri, 63110, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluation of Chemotherapy Prior to Surgery With or Without Zometa for Women With Locally Advanced Breast Cancer
Official Title  ICMJE Impact of Neoadjuvant Chemotherapy With or Without Zometa on Occult Micrometastases and Bone Density in Women With Locally Advanced Breast Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • Drug: Zometa
    Other Name: Zoledronic acid
  • Drug: Epirubicin
    Other Name: Ellence
  • Drug: Docetaxel
    Other Name: Taxotere
  • Drug: Trastuzumab
    ONLY for patients that are Her-2 overexpressing by 3+ by ICH for FSH
    Other Name: Herceptin
  • Radiation: External beam radiation
  • Procedure: Modified radical mastectomy or breast conserving surgery with axillary lymph node dissection
Study Arms  ICMJE
  • 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

    Interventions:
    • Drug: Zometa
    • Drug: Epirubicin
    • Drug: Docetaxel
    • Drug: Trastuzumab
    • 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

    Interventions:
    • Drug: Epirubicin
    • Drug: Docetaxel
    • Drug: Trastuzumab
    • Radiation: External beam radiation
    • Procedure: Modified radical mastectomy or breast conserving surgery with axillary lymph node dissection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 17, 2005)
120
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00242203
Other Study ID Numbers  ICMJE 02-0788 / 201104272
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE
  • Novartis
  • Pfizer
Investigators  ICMJE
Principal Investigator:Rebecca Aft, M.D., Ph.D.Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP