Famitinib in Combination With Camrelizumab and TPC in The First-line Treatment of Immunomodulatory Locally Advanced or Metastatic TNBC.

Triple-Negative Breast Cancer Clinical Trial

Official title:

An Open, Randomized Phase III Study of Famitinib With Camrelizumab Plus Treatment of Physician's Choice (TPC) Versus Camrelizumab Plus TPC in The First-line Treatment of Immunomodulatory Locally Advanced or Metastatic Triple-negative Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05760378
• Other study ID #: BCTOP-T-M02
• Status: Recruiting
• Phase: Phase 3
• Start date: March 17, 2023
• Est. completion date: January 1, 2027

Study information

• Verified date: June 2023
• Source: Fudan University
• Contact: Zhimin Shao
• Phone: 86-021-64175590
• Email: zhimingshao[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is being conducted to evaluate the Famitinib with Camrelizumab plus treatment of physician's choice (TPC) versus Camrelizumab plus TPC in Patients with Unresectable Locally Advanced or Metastatic Immunomodulatory Triple Negative Breast Cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 223
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

• 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

Exclusion Criteria:

• 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.

• Coagulant function abnormality

• artery/venous thromboembolism event

• History of autoimmune disease

• Positive test for human immunodeficiency virus

• Active hepatitis B or hepatitis C

• Uncontrolled pleural effusion and ascites • Known central nervous system (CNS) disease.

• Long-term unhealing wound or incomplete healing of fracture

• urine protein =2+ and 24h urine protein quantitative > 1 g.

• Pregnancy or lactation.

• Thyroid dysfunction.

• Peripheral neuropathy grade =2.

• People with high blood pressure;

• A history of unstable angina;

• New diagnosis of angina pectoris.

• Myocardial infarction incident .

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Neoplasms
• Triple-Negative Breast Cancer

Intervention

Drug:
• Famitinib
TKI
• Camrelizumab
PD1 inhibitor
• nab-Palitaxel/Capecitabine/Eribulin Mesylate/Carboplatin
TPC

Locations

Country	Name	City	State
China	Breast cancer institute of Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	time to progressive disease (according to RECIST1.1)	Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 1.5 years)
Secondary	ORR	The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)	max 6 months
Secondary	DoR	Duration of Overall Response.The date of the first assessed PR/CR (according to RECIST 1.1) to the date of the first assessed tumor progression (according to RECIST 1.1) or death from any cause.	max 6 months
Secondary	CBR	The percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the participants.	max 6 months
Secondary	OS	time to death due to any cause	approximately 3 years