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

NCT05670925 | Unknown Phase 2

• 1 other identifier: C-plus-Pairs
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Triple-Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression Free Survival

  max 24 months

Secondary Outcomes (1)

• ORR

  8 WEEKS

Study Arms (1)

Camrelizumab plus Famitinib with/without nab-palitaxel

EXPERIMENTAL

Drug: Camrelizumab plus Famitinib with/without nab-Palitaxel

Interventions

Camrelizumab plus Famitinib with/without nab-Palitaxel DRUG

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-1α. Patients of PD after 2 cycles (8 weeks) will be recorded as PFS-1β. Patients of SD with 2 cycles of dual therapy wlii receive triple therapy regimen: Camrelizumab and Famitinib with nab-Paclitaxel.

Camrelizumab plus Famitinib with/without nab-palitaxel

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center Shanghai, China, 200032

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

camrelizumab

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

ZHONGHUA WANG, MD

CONTACT

+86 021-6417559; zhonghuawang95@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 2, 2023
• First Posted: January 4, 2023
• Study Start: March 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

CN (1)