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NCT05760378RecruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 6 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
223 (estimated)
First submitted
27 Feb 2023
Start date
17 Mar 2023
Primary completion date
1 Jan 2025
Lead sponsor
Fudan University
NCT number
NCT05760378

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 223
  • From 17 Mar 2023 to the primary completion date, 1 Jan 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous received anti-VEGFR small molecule tyrosine kinase inhibitors (e.g. famitinib, sorafenib, Sunitinib, regorafenib, etc.) for treatment of the patients .

Other illness

  • A history of bleeding, any serious bleeding events.
  • Important blood vessels around tumors has been infringed and high risk of bleeding.
  • artery/venous thromboembolism event
  • History of autoimmune disease
  • Active hepatitis B or hepatitis C
  • Uncontrolled pleural effusion and ascites • Known central nervous system (CNS) disease.
  • A history of unstable angina;
  • New diagnosis of angina pectoris.
  • Myocardial infarction incident .

Other

  • Coagulant function abnormality
  • Positive test for human immunodeficiency virus
  • 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;

Who the study is looking for

  • 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

Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
breast cancer institute of Fudan University Cancer Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.