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

NCT ID: NCT00172068

Last Updated: 2009-12-23

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.

Detailed Description

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Conditions

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Primary Breast Cancer

Keywords

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Primary breast cancer Bone metastases Minimal residual disease Bisphosphonates

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

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis Pharmaceuticals

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmeceuticals

Locations

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Novartis Invstigative Site

Bielefeld, , Germany

Site Status

Novartis Investigative Site

Hanover, , Germany

Site Status

Novartis Investigative Site

München, , Germany

Site Status

Novartis Investigative Site

Tübingen, , Germany

Site Status

Countries

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Germany

References

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Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.

Reference Type DERIVED
PMID: 38979716 (View on PubMed)

Banys M, Solomayer EF, Gebauer G, Janni W, Krawczyk N, Lueck HJ, Becker S, Huober J, Kraemer B, Wackwitz B, Hirnle P, Wallwiener D, Fehm T. Influence of zoledronic acid on disseminated tumor cells in bone marrow and survival: results of a prospective clinical trial. BMC Cancer. 2013 Oct 15;13:480. doi: 10.1186/1471-2407-13-480.

Reference Type DERIVED
PMID: 24128322 (View on PubMed)

Other Identifiers

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CZOL446GDE05

Identifier Type: -

Identifier Source: org_study_id