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

Sponsor
Fudan University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05760378
Collaborator
(none)
223
1
2
46.1
4.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
223 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

Famitinib in Combination With Camrelizumab and TPC

Drug: Famitinib
TKI

Drug: Camrelizumab
PD1 inhibitor

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

Active Comparator: B

Combination With Camrelizumab and TPC

Drug: Camrelizumab
PD1 inhibitor

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

Outcome Measures

Primary Outcome Measures

  1. PFS [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)]

    time to progressive disease (according to RECIST1.1)

Secondary Outcome Measures

  1. ORR [max 6 months]

    The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)

  2. DoR [max 6 months]

    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.

  3. CBR [max 6 months]

    The percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the participants.

  4. OS [approximately 3 years]

    time to death due to any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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 .

Contacts and Locations

Locations

Site City State Country Postal Code
1 Breast cancer institute of Fudan University Cancer Hospital Shanghai Shanghai China 200032

Sponsors and Collaborators

  • Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhimin Shao, Professor, Fudan University
ClinicalTrials.gov Identifier:
NCT05760378
Other Study ID Numbers:
  • SCHBCC-N048
First Posted:
Mar 8, 2023
Last Update Posted:
Mar 8, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 8, 2023