Status:
UNKNOWN
An Umbrella Trial Based on Molecular Pathway for Patients With Metastatic TNBC.
Lead Sponsor:
Fudan University
Conditions:
TNBC - Triple-Negative Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
This is a Phase II, open-label, randomized controlled umbrella trial evaluating the efficacy and safety of multiple targeted treatment in patients with metastaticTNBC.
Detailed Description
This is a Phase II, open-label, randomized controlled umbrella trial evaluating the efficacy and safety of multiple targeted treatment vs. traditional chemotherapy in patients with unresectable locall...
Eligibility Criteria
Inclusion
- 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.
- Adequate hematologic and end-organ function, laboratory test results, obtained within 14 days prior to initiation of study treatment.
- Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
- Patients had received no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer
- 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
- Symptomatic, untreated, or actively progressing CNS metastases
- Active or history of autoimmune disease or immune deficiency
- Active hepatitis B or hepatitis C
- Significant cardiovascular disease
- 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
- Treatment with taxel-based chemotherapy within 6 months
- Treatment with chemotherapy, radiotherapy,immunotherapy or surgery (outpatient clinic surgery excluded)within3 weeks prior to initiation of study treatment.
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study
- Previous received anti-VEGFR small molecule tyrosine kinase inhibitors (e.g. famitinib, sorafenib, Sunitinib, regorafenib, etc.) for treatment of the patients .
- A history of bleeding, any serious bleeding events.
- Important blood vessels around tumors has been infringed and high risk of bleeding.
- Long-term unhealing wound or incomplete healing of fracture
- Urine protein ≥2+ and 24h urine protein quantitative \> 1 g.
- Arrhythmia for long-term use of anti-arrhythmic drugs and New York heart association class II or higher cardiac insufficiency
Key Trial Info
Start Date :
July 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT04395989
Start Date
July 28 2020
End Date
December 31 2024
Last Update
December 22 2023
Active Locations (1)
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1
Cancer Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 200032