Zoledronic Acid in the Treatment of Breast Cancer With Minimal Residual Disease in the Bone Marrow

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Brief Summary

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Metastatic bone disease is an important prognostic factor for survival which will in median be close to two years after first diagnosis of osseous metastases. This open-label study will investigate the safety and efficacy of zoledronic acid in patients with breast cancer and minimal residual disease in the bone marrow.

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Detailed Description

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Conditions

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Primary Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Group

Group Type EXPERIMENTAL

Zoledronic acid + Calcium/Vitamin D

Intervention Type DRUG

Control Group

Group Type ACTIVE_COMPARATOR

Zoledronic acid + Calcium/Vitamin D

Intervention Type DRUG

Interventions

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Zoledronic acid + Calcium/Vitamin D

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No