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

This study has been completed.
Sponsor:
Collaborators:
Novartis
Pfizer
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00242203
First received: October 17, 2005
Last updated: August 9, 2013
Last verified: August 2013

October 17, 2005
August 9, 2013
October 2002
August 2007   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00242203 on ClinicalTrials.gov Archive Site
  • Impact of Zometa (zoledronic acid) on time and site of relapse [ Time Frame: 5 years from registration ] [ Designated as safety issue: No ]
  • Effect of treatment on quality of life in women undergoing treatment for LABC. [ Time Frame: Baseline and 12-15 months from registration ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Breast Neoplasms
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
May 2011
August 2007   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00242203
02-0788 / 201104272
Yes
Washington University School of Medicine
Washington University School of Medicine
  • Novartis
  • Pfizer
Principal Investigator: Rebecca Aft, M.D., Ph.D. Washington University School of Medicine
Washington University School of Medicine
August 2013

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