Overview

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