A Trial of Camrelizumab in Combination With Nab-paclitaxel and Famitinib as a First Line Treatment in Patients With Unresectable Locally Advanced or Metastatic Immunomodulatory Triple Negative Breast Cancer(FUTURE-C-PLUS)

Conditions

Triple-Negative Breast Cancer

Brief summary

The study is being conducted to evaluate the efficacy, safety of camrelizumab in combination with nab-paclitaxel and famitinib in Patients with unresectable locally advanced or metastatic immunomodulatory triple negative breast Cancer..

Zhu XZ, Zhou YF, Ying XH, Wang YY, Ding XH, Zhang KY, Shao ZM, Jin X, Jiang YZ, Wang ZH.

2026-03-02

10.1172/jci188989

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10.1158/1538-7445.sabcs23-po1-15-08

Abstract PO2-13-04: Single cell characterization of senescent CD8+ T cell promotes immunotherapy resistance in early-stage triple-negative breast cancer

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10.1158/1538-7445.sabcs23-po2-13-04

The overall survival analysis of FUTURE-C-PLUS: Combination of famitinib with camrelizumab plus nab-paclitaxel as first-line treatment for advanced, immunomodulatory triple-negative breast cancer—An open-label, single-arm, phase 2 trial.

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10.1200/jco.2023.41.16_suppl.1086

Abstract PD4-05: PD4-05 Integrated multi-cohort profiling identifies CCL19+ dendritic cells to potentiate immunotherapy efficacy in triple-negative breast cancer

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Combined angiogenesis and PD-1 inhibition for immunomodulatory TNBC: concept exploration and biomarker analysis in the FUTURE-C-Plus trial.

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2022-03-2568 citations

10.1186/s12943-022-01536-6

Abstract P2-14-04: Updated data from FUTURE-C-PLUS: Combination of famitinib with camrelizumab plus nab-paclitaxel as first-line treatment for advanced, immunomodulatory triple-negative breast cancer, an open-label, single-arm, phase 2 trial

Li Chen, Yi‐Zhou Jiang, Song‐Yang Wu, Jiong Wu, Gen‐Hong Di et al. (22 authors)

Cancer Research2022-02-15

10.1158/1538-7445.sabcs21-p2-14-04

Combination of famitinib with camrelizumab plus nab-paclitaxel as first-line treatment for patients with immunomodulatory advanced triple-negative breast cancer (FUTURE-C-PLUS): A prospective, single-arm, phase 2 study.

Li Chen, Zhimin Shao, Zhonghua Wang, Wentao Yang, Yi‐Zhou Jiang et al. (20 authors)

Journal of Clinical Oncology2021-05-2011 citations

10.1200/jco.2021.39.15_suppl.1007

Interventions

DRUGcamrelizumab in combination with nab-paclitaxel and famitinib

camrelizumab in combination with nab-paclitaxel and famitinib for triple negative breast cancer

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

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 ; * Arrhythmia for long-term use of anti-arrhythmic drugs and New York heart association class II or higher cardiac insufficiency

Design outcomes

Primary

Measure	Time frame	Description
ORR	Baseline up to 53 months (assessed at Screening, every 8 weeks for the first 12 months, thereafter every 12 weeks until disease progression or death, whichever occurs first	Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 in all Participants

Countries

China

Outcome results

None listed