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

NCT ID: NCT04395989

Last Updated: 2023-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-28

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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TNBC - Triple-Negative Breast Cancer

Keywords

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TNBC Molecular Subtype Precision Treatment Umbrella Trial First Line

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LAR-HER2mut

If patients were LAR subtype with HER2 gene activated mutation

Group Type EXPERIMENTAL

A1: Pyrotinib with nab-paclitaxel

Intervention Type DRUG

A1: pyrotinib(EGFR-TKI) 400mg po qd + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

A2: nab-paclitaxel

Intervention Type DRUG

A2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

LAR-PI3K/AKTmut

If patients were LAR subtype without HER2 gene activated mutation, but had PI3K/AKT/mTOR pathway mutation

Group Type EXPERIMENTAL

B1: everolimus with nab-paclitaxel

Intervention Type DRUG

B1: everolimus 10mg po qd + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

B2: nab-paclitaxel

Intervention Type DRUG

B2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

IM

If patients were IM subtype (CD8 positive T cell more than 10%)

Group Type EXPERIMENTAL

C1: PD-1 with nab-paclitaxel and famitinib

Intervention Type DRUG

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

C2: nab-paclitaxel

Intervention Type DRUG

C2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

BLIS/MES-PI3K/AKTWT

If patients were BLIS subtype or MES subtype without PI3K/AKT/mTOR pathway activation

Group Type EXPERIMENTAL

D1: VEGFR and nab-paclitaxel, with maintenance of VEGFR and capecitabine

Intervention Type DRUG

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.

D2: nab-paclitaxel, with maintenance of capecitabine

Intervention Type DRUG

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.

MES-PI3K/AKTmut

If patients were MES subtype and had PI3K/AKT/mTOR pathway activation

Group Type EXPERIMENTAL

E1: everolimus with nab-paclitaxel

Intervention Type DRUG

E1: everolimus 10mg po qd + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

E2: nab-paclitaxel

Intervention Type DRUG

E2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

Interventions

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A1: Pyrotinib with nab-paclitaxel

A1: pyrotinib(EGFR-TKI) 400mg po qd + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

Intervention Type DRUG

A2: nab-paclitaxel

A2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

Intervention Type DRUG

B1: everolimus with nab-paclitaxel

B1: everolimus 10mg po qd + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

Intervention Type DRUG

B2: nab-paclitaxel

B2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

Intervention Type DRUG

C1: PD-1 with nab-paclitaxel and famitinib

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

Intervention Type DRUG

C2: nab-paclitaxel

C2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

Intervention Type DRUG

D1: VEGFR and nab-paclitaxel, with maintenance of VEGFR and capecitabine

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.

Intervention Type DRUG

D2: nab-paclitaxel, with maintenance of capecitabine

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.

Intervention Type DRUG

E1: everolimus with nab-paclitaxel

E1: everolimus 10mg po qd + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

Intervention Type DRUG

E2: nab-paclitaxel

E2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

Intervention Type DRUG

Other Intervention Names

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SHR1258 Camrelizumab SHR1210 Bevacizumab (BP102)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Zhimin Shao

Director of General Surgery of Fudan Shanghai Cancer Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cancer Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Fan L, Wang ZH, Ma LX, Wu SY, Wu J, Yu KD, Sui XY, Xu Y, Liu XY, Chen L, Zhang WJ, Jin X, Xiao Q, Shui RH, Xiao Y, Wang H, Yang YS, Huang XY, Cao AY, Li JJ, Di GH, Liu GY, Yang WT, Hu X, Xia Y, Liang QN, Jiang YZ, Shao ZM. Optimising first-line subtyping-based therapy in triple-negative breast cancer (FUTURE-SUPER): a multi-cohort, randomised, phase 2 trial. Lancet Oncol. 2024 Feb;25(2):184-197. doi: 10.1016/S1470-2045(23)00579-X. Epub 2024 Jan 8.

Reference Type DERIVED
PMID: 38211606 (View on PubMed)

Other Identifiers

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SCHBCC-N031

Identifier Type: -

Identifier Source: org_study_id