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Recruiting

NCT Number: NCT05760378

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

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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Lei Fan, MD

CONTACT

[email protected]

86-21-641755901105

Lei Fan, MD

SUB_INVESTIGATOR

Wenjuan Zhang, MD

SUB_INVESTIGATOR

Ying Zhou

SUB_INVESTIGATOR

Zhi-Ming Shao, MD

CONTACT

[email protected]

86-21-641755901105

Zhi-Ming Shao, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Famitinib

Drug

TKI

Camrelizumab

Drug

PD1 inhibitor

nab-Palitaxel/Capecitabine/Eribulin Mesylate/Carboplatin

Drug

TPC

Primary outcomes

  1. PFS

    Time frame: 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 outcomes

  1. ORR

    Time frame: max 6 months

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

  2. DoR

    Time frame: 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

    Time frame: max 6 months

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

  4. OS

    Time frame: approximately 3 years

    time to death due to any cause

Study contacts

Contact information is provided by the study sponsor or research team.

Zhimin Shao

CONTACT

[email protected]

86-021-64175590 ext. 8888

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Mar 8, 2023
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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