An Umbrella Trial Based on Molecular Pathway for Patients With Metastatic TNBC.

STATUS

Recruiting
participants needed

138
sponsor

Fudan University

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Updated on 19 February 2024

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cancer

breast cancer

measurable disease

solid tumour

paclitaxel

targeted therapy

triple-negative breast cancer

capecitabine

everolimus

stage iv breast cancer

pyrotinib

HER2

Summary

This is a Phase II, open-label, randomized controlled umbrella trial evaluating the efficacy and safety of multiple targeted treatment in patients with metastaticTNBC.

Description

This is a Phase II, open-label, randomized controlled umbrella trial evaluating the efficacy and safety of multiple targeted treatment vs. traditional chemotherapy in patients with unresectable locally advanced or metastatic triple negative breast cancer. The specific grouping of patients' depends on FUSCC 500+ gene panel testing and IHC subtype staining.These tests would be done on their rebiopsy tumor specimen. Specifically, as to TNBC molecular subtyping,FUSCC data identified the genomic aberrations that drive each TNBC subtype by applying an integrative analysis combining somatic mutation, copy number aberrations (CNAs) and gene expression profiles, which classified TNBC patients into four subtypes, namely luminal androgen receptor (LAR), immunomodulatory (IM), basal-like immune suppressed (BLIS), and mesenchymal-like (MES). Then, FUSCC conducted a IHC subtyping model to replace complex genomic sequencing, which have been validated in FUSCC cohort.FUSCC 500+ gene panel was developed combining public database(TCGA, METABRIC, 560WES, MSKCC-IMPACT ect.) and FUSCC private TNBC database.

Details

Condition	TNBC - Triple-Negative Breast Cancer
Age	18years - 70years
Treatment	A1: Pyrotinib with Capecitabine, A2: nab-paclitaxel, B1: everolimus with nab-paclitaxel, B2: nab-paclitaxel, C1: PD-1 with nab-paclitaxel and famitinib, C2: nab-paclitaxel, D1: VEGFR and nab-paclitaxel, D2: nab-paclitaxel, E1: Everolimus with nab-paclitaxel, E2: nab-paclitaxel
Clinical Study Identifier	NCT04395989
Sponsor	Fudan University
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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, obtained within 14 days prior to initiation of study treatment
	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
	For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as outlined for each specific treatment arm
	Have the cognitive ability to understand the protocol and be willing to participate and to be followed up
Exclusion Criteria
	Symptomatic, untreated, or actively progressing CNS metastases
	Active or history of autoimmune disease or immune deficiency
	Active hepatitis B or hepatitis C
	Significant cardiovascular disease
	History of malignancy other than breast cancer within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death
	Treatment with taxel-based chemotherapy within 6 months
	Treatment with chemotherapy, radiotherapy,immunotherapy or surgery (outpatient clinic surgery excluded)within3 weeks prior to initiation of study treatment
	Pregnancy or breastfeeding, or intention of becoming pregnant during the study
	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
	Long-term unhealing wound or incomplete healing of fracture
	Urine protein 2+ and 24h urine protein quantitative > 1 g
	Arrhythmia for long-term use of anti-arrhythmic drugs and New York heart association class II or higher cardiac insufficiency

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An Umbrella Trial Based on Molecular Pathway for Patients With Metastatic TNBC.