A Phase 2 interventional study of A1: Pyrotinib with nab-paclitaxel and A2: nab-paclitaxel in TNBC - Triple-Negative Breast Cancer, sponsored by Fudan University. Active, not recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-12-22.
Sponsored by Fudan University · Phase 2, Interventional, and Treatment
This is a Phase II, open-label, randomized controlled umbrella trial evaluating the efficacy and safety of multiple targeted treatment in patients with metastaticTNBC.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 139 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
If patients were LAR subtype with HER2 gene activated mutation
Drug: A1: Pyrotinib with nab-paclitaxel · Drug: A2: nab-paclitaxel
If patients were LAR subtype without HER2 gene activated mutation, but had PI3K/AKT/mTOR pathway mutation
Drug: B1: everolimus with nab-paclitaxel · Drug: B2: nab-paclitaxel
If patients were IM subtype (CD8 positive T cell more than 10%)
Drug: C1: PD-1 with nab-paclitaxel and famitinib · Drug: C2: nab-paclitaxel
If patients were BLIS subtype or MES subtype without PI3K/AKT/mTOR pathway activation
Drug: D1: VEGFR and nab-paclitaxel, with maintenance of VEGFR and capecitabine · Drug: D2: nab-paclitaxel, with maintenance of capecitabine
If patients were MES subtype and had PI3K/AKT/mTOR pathway activation
Drug: E1: everolimus with nab-paclitaxel · Drug: E2: nab-paclitaxel
A1: pyrotinib(EGFR-TKI) 400mg po qd + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle
Also known as: SHR1258
A2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle
B1: everolimus 10mg po qd + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle
B2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle
C1: PD-1 antibody SHR1210 200mg d1,15 ivgtt + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt + famitinib 20mg po qd, 4 weeks as a cycle
Also known as: Camrelizumab, SHR1210
C2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle
D1: VEGFR bevacizumab 10mg/kg d1,15 ivgtt + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle. Capecitabine with bevacizumab maintenance if intolerable toxicity was observed with no progression. Capecitabine maintenance 1000mg/m2 po bid d1-d14 every 3 weeks and bevacizumab 10mg/kg d1,15 ivgtt every 4 weeks.
Also known as: Bevacizumab (BP102)
D2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle. Capecitabine maintenance if intolerable toxicity was observed with no progression. Capecitabine maintenance 1000mg/m2 po bid d1-d14 every 3 weeks.
E1: everolimus 10mg po qd + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle
E2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle
Progression Free Survival (PFS)
Refers to the time between the patient's enrollment and any recorded tumor progression or death from any cause.
Time frame: approximately 3 years
Overall Survival (OS)
Refers to the period from the date of the first study dose to the date of death for any reason.
Time frame: approximately 3 years
Objective response rate (ORR)
Defined as the proportion of patients whose tumors shrink to a certain amount and remain for a certain period of time, including cases of CR and PR.
Time frame: approximately 3 years
Duration of Response (DoR)
Defined as the date from the first recording of tumor response (assessed according to RECIST 1.1) to the first recording of the objective progression of the tumor (assessed according to RECIST 1.1) or to the date of death for any reason, whichever occurs first.
Time frame: approximately 3 years
Disease Control Rate (DCR)
The proportion of subjects who received treatment and whose best overall response (BOR) was assessed as complete response (CR), partial response (PR) and stable disease (SD) ≥4 weeks according to RECIST1.1.
Time frame: approximately 3 years
Safety: Adverse Events (AE)
AE refers to any untoward medical occurrence in a study subject administered an investigational product which does not necessarily have a causal relationship with the treatment. AE is assessed according to the NCI-CTC AE 5.0.
Time frame: approximately 3 years
This study is active, not recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Fudan University