NCT05760378

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P25-P50 for phase_3

Timeline
8mo left

Started Mar 2023

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Mar 2023Jan 2027

First Submitted

Initial submission to the registry

February 27, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

March 17, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

February 6, 2024

Status Verified

June 1, 2023

Enrollment Period

1.8 years

First QC Date

February 27, 2023

Last Update Submit

February 4, 2024

Conditions

Triple-Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • ORR

    max 6 months

  • DoR

    max 6 months

  • CBR

    max 6 months

  • OS

    approximately 3 years

Study Arms (2)

A

EXPERIMENTAL

Famitinib in Combination With Camrelizumab and TPC

Drug: FamitinibDrug: CamrelizumabDrug: nab-Palitaxel/Capecitabine/Eribulin Mesylate/Carboplatin

B

ACTIVE COMPARATOR

Combination With Camrelizumab and TPC

Drug: CamrelizumabDrug: nab-Palitaxel/Capecitabine/Eribulin Mesylate/Carboplatin

Interventions

FamitinibDRUG

TKI

A
CamrelizumabDRUG

PD1 inhibitor

AB
nab-Palitaxel/Capecitabine/Eribulin Mesylate/CarboplatinDRUG

TPC

AB

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (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;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

famitinibcamrelizumab

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Zhimin Shao

CONTACT

86-021-64175590zhimingshao@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 8, 2023

Study Start

March 17, 2023

Primary Completion

January 1, 2025

Study Completion (Estimated)

January 1, 2027

Last Updated

February 6, 2024

Record last verified: 2023-06

Locations

CN(1)