A Trial Exploring the Opportune Administration of Nab-paclitaxel in the First Line Treatment, Camrelizumab Combined With Nab-paclitaxel and Famitinib, of TNBC.

Triple-Negative Breast Cancer Clinical Trial

Official title:

The Opportune Administration of Nab-paclitaxel in the First Line Treatment Strategy, Camrelizumab and Famitinib With/Without Nab-paclitaxel, of Patients With Unresectable Locally Advanced or Metastatic Immunomodulatory Triple Negative Breast Cancer：An Open, Single-arm, Multicenter Phase II Clinical Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05670925
• Other study ID #: C-plus-Pairs
• Status: Recruiting
• Phase: Phase 2
• Start date: March 1, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: February 2023
• Source: Fudan University
• Contact: ZHONGHUA WANG, MD
• Phone: +86 021-6417559
• Email: zhonghuawang95[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is being conducted to evaluate the Opportune Administration of Nab-paclitaxel in the First Line Treatment Strategy, Camrelizumab and Famitinib with/without Nab-paclitaxel, of Patients with Unresectable Locally Advanced or Metastatic Immunomodulatory Triple Negative Breast Cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• 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:
• Camrelizumab plus Famitinib with/without nab-Palitaxel
After enrollment confirmed, the regimen of Camrelizumab Combined with Famitinib will be conducted for 2 cycles (8 weeks). Patients of CR or PR after 2 cycles (8 weeks) will enter dual-therapy maintenance phase until disease progression and will be recorded as PFS-1a. Patients of PD after 2 cycles (8 weeks) will be recorded as PFS-1ß. Patients of SD with 2 cycles of dual therapy wlii receive triple therapy regimen: Camrelizumab and Famitinib with nab-Paclitaxel.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center Shanghai, China, 200032	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	Progression Free Survival	max 24 months
Secondary	ORR	Objective Response Rate according to RECIST 1.1	8 WEEKS