FUSCC Refractory TNBC Platform Study (FUTURE2.0)
Precision Platform Study of Refractory Triple-negative Breast Cancer Based on Molecular Subtyping（(A Phase II, Open-label, Single-center Platform Study）
1 other identifier
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2023
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2023
CompletedFirst Posted
Study publicly available on registry
March 1, 2023
CompletedStudy Start
First participant enrolled
March 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
April 16, 2026
April 1, 2026
4.8 years
February 19, 2023
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall response rate (ORR)
The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the completion of study (approximately 3 years)
Secondary Outcomes (5)
Progression Free Survival (PFS)
Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the completion of study (approximately 3 years)
Duration of Response (DoR)
Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the completion of study(approximately 3 years)
Disease Control Rate (DCR)
Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the completion of study(approximately 3 years)
Overall Survival (OS)
Randomization to death from any cause, through the end of study (approximately 3 years)
CTCAE scale (V5.0)
Up to One Year during follow-up
Study Arms (9)
IM/HER2-low
EXPERIMENTALIf patients were triple-negative breast cancer with IM subtype and HER2-low-positive
IM/HER2-0
EXPERIMENTALIf patients were triple-negative breast cancer with IM subtype and HER2-zero
BLIS / HER2-low
EXPERIMENTALIf patients were triple-negative breast cancer with BLIS subtype and HER2-low-positive
BLIS /HER2-0
EXPERIMENTALIf patients were triple-negative breast cancer with BLIS subtype and HER2-zero
LAR / HER2-low
EXPERIMENTALIf patients were triple-negative breast cancer with LAR subtype and HER2-low-positive
LAR /HER2-0
EXPERIMENTALIf patients were triple-negative breast cancer with LAR subtype and HER2-zero
MES/ HER2-low
EXPERIMENTALIf patients were triple-negative breast cancer with MES subtype and HER2-low-positive
MES /HER2-0
EXPERIMENTALIf patients were triple-negative breast cancer with MES subtype and HER2-zero
All-Comer/TQB2102 plus TQB2868
EXPERIMENTALInterventions
A2: SHR-A1811: an anti-HER2 antibody-drug conjugate (ADC) Camrelizumab: an anti-programmed death-1 (PD-1) antibody
B2: TROP2 ADC : an Trophoblast cell-surface antigen 2 (TROP2) ADC Camrelizumab: an anti-programmed death-1 (PD-1) antibody
C2: SHR-A1811: an anti-HER2 antibody-drug conjugate (ADC) BP102: a humanized recombinant monoclonal IgG1 antibody (biosimilar to bevacizumab)
D2: TROP2 ADC : an Trophoblast cell-surface antigen 2 (TROP2) ADC BP102: a humanized recombinant monoclonal IgG1 antibody (biosimilar to bevacizumab)
E1: SHR-A1811 an anti-HER2 antibody-drug conjugate (ADC) everolimus： an mTOR inhibitor
TQB2102: an anti-HER2 antibody-drug conjugate (ADC) TQB2868: an anti-PD-1/TGF-β bispecific antibody in all-comer TNBC
Eligibility Criteria
You may qualify if:
- Female aged ≥18 years;
- TNBC invasive breast cancer confirmed by histology (specific definition: ER \<1% positive tumor cells by immunohistochemistry are defined as ER negative, PR \<1% positive tumor cells are defined as PR negative, HER2 0-1+ or HER2 ++ but negative by FISH without amplification was defined as HER2 negative); Locally advanced breast cancer (unable to undergo radical local treatment) or recurrent metastatic breast cancer;
- Progression after at least one prior therapeutic regimens for advanced/metastatic TNBC
- At least one measurable lesion according to RECIST 1.1 (conventional CT scan ≥20 mm, spiral CT scan ≥10 mm, measurable lesion has not received radiotherapy);
- The functions of the main organs are basically normal and meet the following conditions:
- i. Blood routine examination criteria shall meet: HB ≥90 g/L (no blood transfusion within 14 days); The ANC acuity 1.5 x 10\^9 /L; PLT acuity 75 x 10\^9 /L;
- ii. Biochemical tests should meet the following criteria: TBIL ≤1.5×ULN (upper limit of normal value); ALT and AST ≤3×ULN; If liver metastases were present, ALT and AST≤ 5×ULN; Serum Cr ≤1×ULN, endogenous creatinine clearance \> 50 ml/min (Cockcroft-Gault formula);
- They have not received radiotherapy, molecular targeted therapy, or surgery within 3 weeks before the start of the study, and have recovered from the acute toxicity of previous treatment (if surgery was performed, the wound has healed completely); No peripheral neuropathy or grade I peripheral neurotoxicity;
- ECOG score ≤1, and life expectancy ≥3 months;
- Fertile female subjects were required to use a medically approved contraceptive method during the study treatment period and for at least 3 months after the last use of the study drug;
- Subjects volunteered to join the study, signed informed consent, had good compliance, and cooperated with follow-up.
You may not qualify if:
- Radiotherapy (except for palliative causes), chemotherapy, and immunotherapy were used in the first 3 weeks of treatment, except bisphosphonate (which can be used for bone metastasis);
- Uncontrolled central nervous system metastases (indicating symptomatic or symptomatic treatment with glucocorticoids or mannitol);
- A history of clinically important or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction, or ventricular arrhythmia within the last 6 months;
- Persistent grade 1 or higher adverse reactions caused by previous treatments. The exception to this is hair loss or something the researchers don't think should be ruled out. Such cases should be clearly documented in the investigator's notes;
- Underwent major surgery (except minor outpatient procedures, such as placement of vascular access) within 3 weeks of the first course of trial treatment;
- Pregnant or lactating patients;
- Malignancy (except basal cell carcinoma of the skin, which has been cured, and carcinoma in situ of the cervix) in the past 5 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhimin Shao, M.D.
Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 19, 2023
First Posted
March 1, 2023
Study Start
March 30, 2023
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share