FUSCC Refractory TNBC Platform Study (FUTURE2.0)

November 10, 2023 updated by: Zhimin Shao, Fudan University

Precision Platform Study of Refractory Triple-negative Breast Cancer Based on Molecular Subtyping（(A Phase II, Open-label, Single-center Platform Study）

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IM/HER2-low
If patients were triple-negative breast cancer with IM subtype and HER2-low-positive
Drug: A1: SHR-A1811
A1: an anti-HER2 antibody-drug conjugate (ADC)
Drug: A2: SHR-A1811 with Camrelizumab

A2: SHR-A1811: an anti-HER2 antibody-drug conjugate (ADC)

Camrelizumab: an anti-programmed death-1 (PD-1) antibody

Other Names:
  • SHR-1210
Experimental: IM/HER2-0
If patients were triple-negative breast cancer with IM subtype and HER2-zero
Drug: B1: TROP2 ADC
B1: an Trophoblast cell-surface antigen 2 (TROP2) ADC
Drug: B2: TROP2 ADC with Camrelizumab

B2: TROP2 ADC : an Trophoblast cell-surface antigen 2 (TROP2) ADC

Camrelizumab: an anti-programmed death-1 (PD-1) antibody

Other Names:
  • SHR-1210
Experimental: BLIS / HER2-low
If patients were triple-negative breast cancer with BLIS subtype and HER2-low-positive
Drug: C1: SHR-A1811
C1: an anti-HER2 antibody-drug conjugate (ADC)
Drug: C2: SHR-A1811 with BP102

C2: SHR-A1811: an anti-HER2 antibody-drug conjugate (ADC)

BP102: a humanized recombinant monoclonal IgG1 antibody (biosimilar to bevacizumab)
Experimental: BLIS /HER2-0
If patients were triple-negative breast cancer with BLIS subtype and HER2-zero
Drug: D1: TROP2 ADC
D1: an Trophoblast cell-surface antigen 2 (TROP2) ADC
Drug: D2: TROP2 ADC with BP102

D2: TROP2 ADC : an Trophoblast cell-surface antigen 2 (TROP2) ADC

BP102: a humanized recombinant monoclonal IgG1 antibody (biosimilar to bevacizumab)
Experimental: LAR / HER2-low
If patients were triple-negative breast cancer with LAR subtype and HER2-low-positive
Drug: E1: SHR-A1811
E1: an anti-HER2 antibody-drug conjugate (ADC)
Experimental: LAR /HER2-0
If patients were triple-negative breast cancer with LAR subtype and HER2-zero
Drug: F1: TROP2 ADC
F1: an Trophoblast cell-surface antigen 2 (TROP2) ADC
Experimental: MES/ HER2-low
If patients were triple-negative breast cancer with MES subtype and HER2-low-positive
Drug: G1: SHR-A1811
G1: an anti-HER2 antibody-drug conjugate (ADC)
Experimental: MES /HER2-0
If patients were triple-negative breast cancer with MES subtype and HER2-zero
Drug: H1: TROP2 ADC
H1: an Trophoblast cell-surface antigen 2 (TROP2) ADC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: 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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: 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)
Time to progressive disease (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)
Duration of Response (DoR)
Time Frame: 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 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)
Disease Control Rate (DCR)
Time Frame: 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)
The proportion of patients with the best overall response of CR, PR, or stable disease (SD)
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)
Time Frame: Randomization to death from any cause, through the end of study (approximately 3 years)
Time to death due to any cause
Randomization to death from any cause, through the end of study (approximately 3 years)
CTCAE scale (V5.0)
Time Frame: Up to One Year during follow-up
To evaluate the rate of adverse effects of patient by the standard CTCAE scale (V5.0)
Up to One Year during follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Zhimin Shao, M.D., Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

February 19, 2023

First Submitted That Met QC Criteria

February 19, 2023

First Posted (Actual)

March 1, 2023

Study Record Updates

Last Update Posted (Actual)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCHBCC-N044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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