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Efficacy and Tolerability of Intravenous Zometa® (Zoledronic Acid) 4 mg in Primary Breast Cancer Patients With Disseminated Tumor Cells in Bone Marrow. A Prospective, Randomized, Parallel Group, Open-label, Clinical Pilot Study.


Phase 2
18 Years
N/A
Not Enrolling
Female
Primary Breast Cancer

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Trial Information

Efficacy and Tolerability of Intravenous Zometa® (Zoledronic Acid) 4 mg in Primary Breast Cancer Patients With Disseminated Tumor Cells in Bone Marrow. A Prospective, Randomized, Parallel Group, Open-label, Clinical Pilot Study.


Inclusion Criteria:



- Patients, with primary breast cancer who had undergone complete primary tumor
resection and axillary lymph node dissection

- Evidence of minimal residual disease (disseminated tumor cells in bone marrow)

- Patients had to receive one of the following adjuvant therapy categories:
chemotherapy ± hormonal therapy or hormonal therapy alone

Exclusion Criteria:

- Inflammatory, metastatic or recurrent breast cancer or a history of breast cancer
prior to the currently diagnosed case

- Neo-adjuvant chemotherapy, neo-adjuvant hormonal therapy, or neo-adjuvant
radiotherapy

- Prior stem cell rescue/bone marrow transplant

- History of other cancers aside from non-melanomatous skin cancer or carcinoma in situ
of the uterine cervix

Additional protocol-defined inclusion / exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Reduction of detected tumor cells in bone marrow

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmeceuticals

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

CZOL446GDE05

NCT ID:

NCT00172068

Start Date:

January 2002

Completion Date:

Related Keywords:

  • Primary Breast Cancer
  • Primary breast cancer
  • Bone metastases
  • Minimal residual disease
  • Bisphosphonates
  • Breast Neoplasms
  • Neoplasm, Residual

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