An Umbrella Trial Based on Molecular Pathway for Patients With Metastatic TNBC.

• Status: Recruiting
• Trial end date: 2023-11-15
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Albumin-Bound Paclitaxel; Capecitabine; Everolimus; Paclitaxel; Sirolimus

Criteria

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.

• 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 Criteria:

• 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