Zoledronic Acid as Adjuvant Treatment of Triple-negative Breast Cancer

Phase 3

• Conditions: Triple Negative Breast Cancer
• Interventions: Drug: Zoledronic acid

• Registration Number: NCT02595138
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-10
• Status Verified: 2015-11
• Study First Submitted: 2015-11-02
• Study First Submitted QC: 2015-11-02
• Last Update Submitted: 2015-11-02
• Study First Posted: 2015-11-03
• Last Update Posted: 2015-11-03
• Primary Completion: 2018-10
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 430

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Zoledronic acid	zoledronic acid received

Primary Outcome Measures

Name	Time	Method
disease free survival	3 years after last patient was enrolled	the time from randomization to the time of disease progression or relapse or death

Secondary Outcome Measures

Name	Time	Method
overall survival	5 years after last patient was enrolled	the time from randomization to the time of death
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	up to 28 days after last medication