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

This study is ongoing, but not recruiting participants.
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: June 21, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
 Drug: Zoledronic acid
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Impact of Neoadjuvant Chemotherapy With or Without Zometa on Occult Micrometastases and Bone Density in Women With Locally Advanced Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • The principal study endpoints are presence/absence of bone marrow micrometastases and bone marrow density at the radius, lumbar spine, femoral neck, femoral head and calcaneus. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary endpoints are time from diagnosis to relapse, site of relapse, and quality of life. [ Time Frame: Patients followed until death. ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: October 2002
Estimated Study Completion Date: October 2012
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients assigned to the Zometa group will receive 4 mg IV as a 15-minute infusion every 3 weeks for a total of 17 doses. Neoadjuvant chemotherapy: 4 cycles of Epirubicin/Taxotere; Perform Surgery; Adjuvant Chemotherapy: 2 cycles of Epirubicin/Taxotere (Patients who are HER-2 neu positive will receive Trastuzumab 6 mg/kg q 3 wks for 1 year post surgery); Radiation Therapy, +/- Hormones
 Drug: Zoledronic acid
Patients assigned to the Zometa group will receive 4 mg IV as a 15-minute infusion every 3 weeks for a total of 17 doses.Neoadjuvant chemotherapy: 4 cycles of Epirubicin/Taxotere; Perform Surgery; Adjuvant Chemotherapy: 2 cycles of Epirubicin/Taxotere (Patients who are HER-2 neu positive will receive Trastuzumab 6 mg/kg q 3 wks for 1 year post surgery); Radiation Therapy, +/- Hormones
Placebo Comparator: 2
Placebo; Neoadjuvant chemotherapy: 4 cycles of Epirubicin/Taxotere; Perform Surgery; Adjuvant Chemotherapy: 2 cycles of Epirubicin/Taxotere (Patients who are HER-2 neu positive will receive Trastuzumab 6 mg/kg q 3 wks for 1 year post surgery); Radiation Therapy, +/- Hormones
 Drug: Placebo
Placebo; Neoadjuvant chemotherapy: 4 cycles of Epirubicin/Taxotere; Perform Surgery; Adjuvant Chemotherapy: 2 cycles of Epirubicin/Taxotere (Patients who are HER-2 neu positive will receive Trastuzumab 6 mg/kg q 3 wks for 1 year post surgery); Radiation Therapy, +/- Hormones

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242203

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Novartis
Pfizer
Investigators
Principal Investigator: Rebecca Aft, M.D., Ph.D. Washington University School of Medicine
  More Information

Additional Information:
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine  This link exits the ClinicalTrials.gov site

Publications:
Van Staa T, Abenhaim L, Cooper C: Use of cyclic etidronate and prevention of fractures. Bone 20:103s (abstract), 1997
Reid I, Brown J, Burckhardt P, et al: Intravenous zoledronic acid in postmenopausal women with low bone density. New England Journal of Medicine 346:653-661, 2002
Yin J, Chirgwin J, Taylor S: Dominant negative blockade of the transforming growth factor beta type II receptor decreases breast cancer mediated osteolysis. Journal of Bone and Mineral Research 11:180, 1996

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00242203     History of Changes
Other Study ID Numbers: 02-0788 / 201104272
Study First Received: October 17, 2005
Last Updated: June 21, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Breast Cancer
Neoadjuvant
Micrometastasis

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Epirubicin
Zoledronic acid
 Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013