Clinical trial NCT02595138: Zoledronic Acid as Adjuvant Treatment of Triple-negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Triple Negative Breast Cancer
Keywords: zoledronic acid
triple-negative breast cancer
adjuvant treatment
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Beijing Municipal Science & Technology Commission
First posted: 2015-11-03
Enrollment: 430
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: disease free survival
timeFrame: 3 years after last patient was enrolled
Secondary outcomes:
measure: overall survival
timeFrame: 5 years after last patient was enrolled
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: up to 28 days after last medication
Other outcomes:
Locations:
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Binghe Xu, MD
role: PRINCIPAL_INVESTIGATOR
References: