A Study of Fluzoparib±Apatinib Versus Chemotherapy Treatment of Physician's Choice in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA Mutation
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Jiangsu HengRui Medicine Co., Ltd.
Age
18–70
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
(Saftey Lead-in + phase 3)Germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious
(Saftey Lead-in + phase 3)human epidermal growth factor receptor type 2 (HER2)-negative metastatic breast cancer
(Saftey Lead-in + phase 3)had received ≤2 lines of chemotherapy for mBC
(Saftey Lead-in + phase 3)Prior therapy with an anthracycline and a taxane in either an adjuvant or metastatic setting.
ER/PR breast cancer positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy.
ECOG performance status 0-1.
Adequate bone marrow, kidney and liver function.
You may not be if
Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib
Prior malignancy unless curatively treated and disease-free for \> 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, DCIS or stage I grade 1 endometrial cancer allowed
Radiation or anti-hormonal therapy or other targeted anticancer therapy within 14 days before randomization
Known to be human immunodeficiency virus positive
Known active hepatitis C virus, or known active hepatitis B virus
Untreated and/or uncontrolled brain metastases
Pregnant or breast-feeding women
Clareo Health | A Study of Fluzoparib±Apatinib Versus Chemotherapy Treatment of Physician's Choice in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA Mutation