Precise Treatment for BLIS Subtype of TNBC in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer
Sponsored by Fudan University
About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Started 2 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
- ECOG Performance Status of 0-1
- Expected lifetime of not less than three months
- Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
- Cancer stage: recurrent or metastatic breast cancer; Local recurrence be confirmed by the researchers could not be radical resection
- Patients had received no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer
- At least one measurable or non-measurable lesion according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), which didn't receive radiation therapy
- The functions of major organs are basically normal
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as outlined for each specific treatment arm
- Have the cognitive ability to understand the protocol and be willing to participate and to be followed up
Exclusion Criteria
- Symptomatic, untreated, or actively progressing CNS metastases
- Significant cardiovascular disease
- Adverse reactions of Grade ≥1 that are still continuing due to previous treatments. Exceptions are those of hair loss or which researchers take it as exception
- Active hepatitis B or hepatitis C
- History of malignancy other than breast cancer within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study
- History of gastrointestinal bleeding within 6 months or any serious bleeding events
- Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 28 days before participating in this study
- Long-term unhealing wound or incomplete healing of fracture
- Urine protein ≥2+ and 24h urine protein quantitative > 1 g
- Patients suffering from hypertension and unable to reach the normal range after antihypertensive drug treatment (systolic blood pressure >140mmHg, diastolic blood pressure >90mmHg)