Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Chinese Academy of Medical Sciences
With
Beijing Municipal Science & Technology Commission
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
•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:
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
You may not be if
•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
Clareo Health | Zoledronic Acid as Adjuvant Treatment of Triple-negative Breast Cancer
