Overview
ABX Plus Cisplatin Versus Gemcitabine Plus Cisplatin in Triple Negative Breast Cancer (TNBC)
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2020-04-01
2020-04-01
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
ABX Plus Cisplatin Versus Gemcitabine Plus Cisplatin in Triple Negative Breast Cancer (TNBC)Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Fudan UniversityTreatments:
Cisplatin
Gemcitabine
Criteria
Inclusion Criteria:1. Females with age between 18 and 70 years old
2. Histological proven unresectable recurrent or advanced breast cancer, including de
novo stage IV disease.
3. Triple-negative for estrogen receptor (ER), progestogen receptor (PR), and human
epithelial receptor-2 (HER2) by immunohistochemistry (ER <1%, PR <1% and Her2
negative). A negative Her2 gene amplification should be verified by FISH test for
those patients with Her2 (2+). For those with Her2 (1+), FISH test might be considered
by the investigator.
4. No prior chemotherapy for metastatic breast cancer is permitted. Prior administration
of chemotherapy in the adjuvant/neoadjuvant setting is acceptable if completed 6
months before the enrollment.
5. At least one measurable disease according to the response evaluation criteria in solid
tumor (RECIST 1.1)
6. Performance status no more than 1
7. All patients enrolled are required to have adequate hematologic, hepatic, and renal
function
8. Life expectancy longer than 12 weeks
9. No serious medical history of heart, lung, liver and kidney
10. Be able to understand the study procedures and sign informed consent.
Exclusion Criteria:
1. Pregnant or lactating women (female patients of child-bearing potential must have a
negative serum pregnancy test within 14 days before the first day of drug dosing, or,
if positive, a pregnancy should be ruled out by ultrasound)
2. Women of child-bearing potential, unwilling to use adequate contraceptive protection
during the process of the study
3. Treatment with radiotherapy at the axial skeleton within 4 weeks before the first
treatment or has not recovered from all toxicities of previous radiotherapy
4. Treatment with an investigational product within 4 weeks before the first treatment
5. Patients with symptomatic central nervous system metastases are not permitted, except
for those with stable and asymptomatic brain metastases who have completed cranial
irradiation, and have at least one measurable lesion outside the brain. Radiotherapy
should be completed within 4 weeks prior to the registration
6. Other active malignancies (including other hematologic malignancies) or other
malignancies within the last 5 years, except for cured nonmelanoma skin cancer or
cervical intraepithelial neoplasia.
7. Patients having a history of clinically significant cardiovascular, hepatic,
respiratory or renal diseases, clinically significant hematological and endocrinal
abnormalities, clinically significant neurological or psychiatric conditions
8. Uncontrolled serious infection