Overview

This trial is active, not recruiting.

Condition triple negative breast cancer
Treatment zoledronic acid
Phase phase 3
Sponsor Chinese Academy of Medical Sciences
Collaborator Beijing Municipal Science & Technology Commission
Start date October 2015
End date October 2018
Trial size 430 participants
Trial identifier NCT02595138, CH-BC-039

Summary

Triple-negative breast cancer is a special type of breast cancer with poor prgnosis and limited choices. Chemotherapy is the only choice of adjuvant systemic treatment options. Previous study suggested that zoledronic acid might have anti-tumor effect by eliminating the number of DTCs(Disseminated Tumor Cell )and had been proved to be effective as adjvant therapy in postmenopausal women whose breast cancer was Homonal receptor positive and who were receiving aromatase inhibitors. So it might be able to improve the survival of triple negative breast cancer patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
zoledronic acid received
zoledronic acid
(No Intervention)
observation

Primary Outcomes

Measure
disease free survival
time frame: 3 years after last patient was enrolled

Secondary Outcomes

Measure
overall survival
time frame: 5 years after last patient was enrolled
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: up to 28 days after last medication

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - •Adult women (≥ 18 years of age) with early stage breast cancer(stage II-III). - Histological confirmation of estrogen and/or progesterone-receptor negative (ER-), human epidermal growth factor receptor 2 negative (HER2 -) breast cancer. ER/PR negative: nuclear reaction< 1%, HER2 negative: HER2; IHC 0,1+ or FISH/CISH (-) in case of IHC 2+ - axillary lymph node positive with other high risk factors: LVI, T>5CM, Grade III - Patients finish standard chemotherapy and/or radiotherapy - ECOG performance status of 0,1 - Adequate bone marrow, hepatic, and renal function - Adequate bone marrow and coagulation function as shown by: - Absolute neutrophil count (ANC) ≥ 1.5 109/L;Platelets>100 x109/L;Hemoglobin (Hgb) > 9.0g/dLINR < 2 - Adequate liver function as shown by: - Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5x ULN - Total serum bilirubin < 1.5 x ULN - Adequate renal function as shown by: - Serum creatinine< 1.5 x ULN - Fasting serum cholesterol <300 mg/dL or 7.75 mmol/L and fasting triglycerides <2.5 x ULN. In case one or both of these thresholds are exceeded, the patient can only be included after initiation of statin therapy and when the above mentioned values have been achieved. - Written informed consent Exclusion Criteria: - •Another malignancy within 5 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer. - Any severe and/or uncontrolled medical conditions, eg. currently active infection - Pregnant or lactating - Patients unwilling to or unable to comply with the protocol

Additional Information

Principal investigator Binghe Xu, MD
Description Triple negative breast cancer patients with high risk factor will be randomized to receive either zoledronic acid or observation after the completion of standard chemotherapy/radiotherapy. Recurrence status will be followed and Disease free survival will be compared. Overall survival is the secondary endpoint.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Chinese Academy of Medical Sciences.