Zoledronic Acid in the Treatment of Breast Cancer With Minimal Residual Disease in the Bone Marrow (MRD-1)

Novartis

Status and phase: Terminated; Phase 2

Conditions: Primary Breast Cancer

Treatments: Drug: Zoledronic acid + Calcium/Vitamin D

Study type: Interventional

Funder types: Industry

Identifiers

NCT00172068

CZOL446GDE05

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Treatment Group

Experimental group

Treatment:

Drug: Zoledronic acid + Calcium/Vitamin D

Control Group

Active Comparator group

Treatment:

Drug: Zoledronic acid + Calcium/Vitamin D