Trial Title:
FUSCC Refractory TNBC Platform Study (FUTURE2.0)
NCT ID:
NCT05749588
Condition:
Triple-negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Conditions: Keywords:
TNBC
Molecular Subtype
Precision Treatment
Platform Study
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
A1: SHR-A1811
Description:
A1: an anti-HER2 antibody-drug conjugate (ADC)
Arm group label:
IM/HER2-low
Intervention type:
Drug
Intervention name:
A2: SHR-A1811 with Camrelizumab
Description:
A2: SHR-A1811: an anti-HER2 antibody-drug conjugate (ADC)
Camrelizumab: an anti-programmed death-1 (PD-1) antibody
Arm group label:
IM/HER2-low
Other name:
SHR-1210
Intervention type:
Drug
Intervention name:
B1: TROP2 ADC
Description:
B1: an Trophoblast cell-surface antigen 2 (TROP2) ADC
Arm group label:
IM/HER2-0
Intervention type:
Drug
Intervention name:
B2: TROP2 ADC with Camrelizumab
Description:
B2: TROP2 ADC : an Trophoblast cell-surface antigen 2 (TROP2) ADC
Camrelizumab: an anti-programmed death-1 (PD-1) antibody
Arm group label:
IM/HER2-0
Other name:
SHR-1210
Intervention type:
Drug
Intervention name:
C1: SHR-A1811
Description:
C1: an anti-HER2 antibody-drug conjugate (ADC)
Arm group label:
BLIS / HER2-low
Intervention type:
Drug
Intervention name:
C2: SHR-A1811 with BP102
Description:
C2: SHR-A1811: an anti-HER2 antibody-drug conjugate (ADC)
BP102: a humanized recombinant monoclonal IgG1 antibody (biosimilar to bevacizumab)
Arm group label:
BLIS / HER2-low
Intervention type:
Drug
Intervention name:
D1: TROP2 ADC
Description:
D1: an Trophoblast cell-surface antigen 2 (TROP2) ADC
Arm group label:
BLIS /HER2-0
Intervention type:
Drug
Intervention name:
D2: TROP2 ADC with BP102
Description:
D2: TROP2 ADC : an Trophoblast cell-surface antigen 2 (TROP2) ADC
BP102: a humanized recombinant monoclonal IgG1 antibody (biosimilar to bevacizumab)
Arm group label:
BLIS /HER2-0
Intervention type:
Drug
Intervention name:
E1: SHR-A1811
Description:
E1: an anti-HER2 antibody-drug conjugate (ADC)
Arm group label:
LAR / HER2-low
Intervention type:
Drug
Intervention name:
F1: TROP2 ADC
Description:
F1: an Trophoblast cell-surface antigen 2 (TROP2) ADC
Arm group label:
LAR /HER2-0
Intervention type:
Drug
Intervention name:
G1: SHR-A1811
Description:
G1: an anti-HER2 antibody-drug conjugate (ADC)
Arm group label:
MES/ HER2-low
Intervention type:
Drug
Intervention name:
H1: TROP2 ADC
Description:
H1: an Trophoblast cell-surface antigen 2 (TROP2) ADC
Arm group label:
MES /HER2-0
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.
Detailed description:
This is a Phase II, open-label, Single-center platform study，Based on FUSCC four TNBC
subtypes and the results of the previous FUTURE trial, the investigators designed this
platform trial, which for combined the TNBC subtyping and genomic sequencing-guided
precision targeted therapy for refractory metastatic TNBC patients. In this trial,
refractory mTNBC patients eligible for inclusion can be divided into various precision
treatment group according to molecular typing and subtyping to evaluate the efficacy and
safety of multiple precision targeted treatment. The research therapy arm can be updated
with the update of basic translational research in our center, especially the refinement
of typing, the discovery of new targets and the development of novel targeted drugs.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Female aged ≥18 years;
2. 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;
3. Progression after at least one prior therapeutic regimens for advanced/metastatic
TNBC
4. 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);
5. 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);
6. 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;
7. ECOG score ≤1, and life expectancy ≥3 months;
8. 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;
9. Subjects volunteered to join the study, signed informed consent, had good
compliance, and cooperated with follow-up.
Exclusion Criteria:
1. 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);
2. Uncontrolled central nervous system metastases (indicating symptomatic or
symptomatic treatment with glucocorticoids or mannitol);
3. 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;
4. 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;
5. Underwent major surgery (except minor outpatient procedures, such as placement of
vascular access) within 3 weeks of the first course of trial treatment;
6. Pregnant or lactating patients;
7. Malignancy (except basal cell carcinoma of the skin, which has been cured, and
carcinoma in situ of the cervix) in the past 5 years.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhimin Shao, M.D.
Email:
zhimingshao@yahoo.com
Contact backup:
Last name:
Yin Liu, M.D.
Email:
liuyinfudan@163.com
Start date:
March 30, 2023
Completion date:
June 2026
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05749588
