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An Umbrella Trial Based on Molecular Pathway for Patients With Metastatic TNBC. | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

An Umbrella Trial Based on Molecular Pathway for Patients With Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer (FUTURE SUPER)

NCT04395989•Fudan University

View on ClinicalTrials.gov

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.

Detailed 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.

Eligibility

Age

18 - 70 years

Sex

FEMALE

Healthy Volunteers

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.
+4 more criteria

Locations (1)

Cancer Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

July 28, 2020

Primary Completion Date

May 31, 2023

Completion Date

December 31, 2024

Last Updated

December 22, 2023

Enrollment

139

ACTUAL participants

Conditions

TNBC - Triple-Negative Breast Cancer

Interventions

A1: Pyrotinib with nab-paclitaxel

DRUG

A2: nab-paclitaxel

DRUG

B1: everolimus with nab-paclitaxel

DRUG

B2: nab-paclitaxel

DRUG

C1: PD-1 with nab-paclitaxel and famitinib

DRUG

C2: nab-paclitaxel

DRUG

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

DRUG

D2: nab-paclitaxel, with maintenance of capecitabine

DRUG

E1: everolimus with nab-paclitaxel

DRUG

E2: nab-paclitaxel

DRUG

Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer

NCT05914961

TNBC - Triple-Negative Breast Cancer

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RECRUITINGPHASE1/PHASE2

Study of AVZO-021 in Patients With Advanced Solid Tumors

NCT05867251

Advanced Solid TumorHR+/HER2- Breast Cancer+7 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 22, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer

Study of AVZO-021 in Patients With Advanced Solid Tumors

BAL0891 in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia

Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early TNBC. INVINCIBLE-4-SAKK

Trop-2 Targeted PET Probes in Advanced TNBC

A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer