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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Rebecca Aft, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

02-0788 / 201104272

NCT ID:

NCT00242203

Start Date:

October 2002

Completion Date:

May 2011

Related Keywords:

  • Breast Neoplasms
  • Breast Cancer
  • Neoadjuvant
  • Micrometastasis
  • Breast Neoplasms
  • Neoplasms

Name

Location

Washington University School of Medicine Saint Louis, Missouri  63110