Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT05749588

FUSCC Refractory TNBC Platform Study (FUTURE2.0)

Led by Fudan University · Updated on 2026-04-16

120

Participants Needed

1

Research Sites

300 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a Phase II, open-label, Single-center platform study research based on molecular subtypes to explore precision therapy in refractory triple-negative breast cancer.

CONDITIONS

Official Title

FUSCC Refractory TNBC Platform Study (FUTURE2.0)

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 18 years or older
  • Confirmed triple-negative invasive breast cancer by histology with specific hormone receptor and HER2 status
  • Locally advanced breast cancer not suitable for radical local treatment or recurrent metastatic breast cancer
  • Disease progression after at least one prior treatment for advanced or metastatic TNBC
  • At least one measurable lesion per RECIST 1.1 criteria, not previously treated with radiotherapy
  • Normal main organ function meeting specific blood counts and biochemical test thresholds
  • No radiotherapy, molecular targeted therapy, or surgery within 3 weeks before study start and recovery from prior treatment toxicity
  • ECOG performance status 0 or 1 with life expectancy of at least 3 months
  • Fertile women must use medically approved contraception during treatment and for 3 months after last study drug use
  • Willingness to provide informed consent, comply with study procedures, and follow-up
Not Eligible

You will not qualify if you...

  • Use of radiotherapy (except palliative), chemotherapy, or immunotherapy within 3 weeks before treatment, except bisphosphonates for bone metastasis
  • Uncontrolled central nervous system metastases requiring symptomatic treatment
  • History of significant or uncontrolled heart disease within the last 6 months
  • Persistent grade 1 or higher adverse reactions from prior treatments, except hair loss or deemed acceptable by investigators
  • Major surgery within 3 weeks before trial treatment, except minor outpatient procedures
  • Pregnant or lactating women
  • History of malignancy in the past 5 years, except cured basal cell carcinoma or cervical carcinoma in situ

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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3
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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, China, 200032

Actively Recruiting

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Research Team

Z

Zhimin Shao, M.D.

CONTACT

Y

Yin Liu, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

9

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FUSCC Refractory TNBC Platform Study (FUTURE2.0) | DecenTrialz