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An Umbrella Trial Based on Molecular Pathway for Patients With Metastatic TNBC in First-line Treatment (FUTURE-Trop2)

Primary Purpose

TNBC - Triple-Negative Breast Cancer

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
A1:SG with SHR3680
A2:SG
B1:SG with SHR1210
B2:SG
C1:SG with SHR3162
C2:SG
D1:SG with VEGFRI
D2:SG
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for TNBC - Triple-Negative Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Women ≥18 years old and ≤70 years old. ECOG body status level 0 ~ 1. The expected survival is not less than 3 months. Breast cancer patients with histologically proven invasive triple-negative breast cancer (specifically defined as estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER-2) who are all negative by pathological tests. Specifically: ER negative: IHC<1%, PR negative: IHC<1%, HER2 negative: IHC-/+ or IHC++ but FISH/CISH negative. All specimens should be verified by the pathology department of the research center, and the molecular typing of relapses and metastases should be re-checked. Tumor stage: recurrent or metastatic breast cancer; Patients with local recurrence need to be confirmed by the investigator that radical surgical resection is not possible. Stage II: patients who have not used paclitaxel or have used paclitaxel in adjuvant/neoadjuvant therapy, but the interval from the end of treatment to relapse is greater than 6 months; No systemic anti-tumor therapy (chemotherapy, targeted therapy, etc.) has been received in the advanced stage. Stage I: The advanced stage has received ≥1 line systemic anti-tumor therapy (chemotherapy, targeted therapy, etc.). Have at least one measurable lesion or unmeasurable lesion according to RECIST version 1.1 (measurable lesion ≥20mm conventional CT scan and ≥10mm spiral CT scan, measurable lesion not receiving radiotherapy). The functions of the main organs are basically normal. Have not received radiotherapy, endocrine therapy, molecular targeted therapy, or surgery (except for procedures unrelated to antitumor therapy such as central venous catheterization) within 3 weeks prior to the start of the study, and have recovered from acute toxic effects of previous treatment (if surgery is available, the wound has fully healed). No peripheral neuropathy or grade I peripheral neurotoxicity. Fertile female subjects are required to use a medically approved contraceptive during study treatment and for at least 3 months after the last use of the study drug; The subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up. Exclusion Criteria: Stage II: patients with adjuvant/neoadjuvant use of paclitaxel but the interval from the end of taxol treatment to recurrence and metastasis is less than 6 months, or have received systemic anti-tumor therapy (chemotherapy, targeted therapy, etc.) in the late stage; Stage I: no systemic anti-tumor therapy (chemotherapy, targeted therapy, etc.) has been received in the advanced stage; Patients with known central nervous system metastasis or history of central nervous system metastasis prior to screening. For patients with clinically suspected central nervous system metastasis, enhanced CT or enhanced Magnetic Resonance Imaging (MRI) must be performed within 28 days before the first dose to rule out central nervous system metastasis. A history of clinically significant or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction within the last 6 months, or ventricular arrhythmia; Persistent grade ≥1 adverse events due to previous treatment. The exception to this is hair loss or something the researchers believe should not be ruled out. Such cases should be clearly documented in the investigator's notes; Major surgery was performed within 3 weeks of the first course of trial treatment (except for minor outpatient surgery, such as placement of vascular access); Pregnant or lactating patients; Other malignancies within the previous 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or skin squamous cell carcinoma. Inability to swallow, chronic diarrhea and intestinal obstruction, there are multiple factors that affect drug use and absorption; There is a third space effusion that cannot be controlled by drainage or other methods (such as excessive pleural fluid and ascites); Participated in clinical trials of other antitumor drugs within 4 weeks before taking the study drug for the first time; long-term unhealed wounds or incomplete healing fractures; Patients with known HBV or HCV infection active phase or hepatitis B DNA≥500, or chronic phase with abnormal liver function; Allergic physique, or known allergic history of the drug components of this program; Or allergic to other monoclonal antibodies; Malignant tumors within the past five years (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    LAR

    IM

    BLIS

    MES

    Arm Description

    Coelomofacial androgen receptor

    Immunoregulatory type

    Basal type and immunosuppressive type

    Interstitial type

    Outcomes

    Primary Outcome Measures

    PFS
    time to progressive disease (according to RECIST1.1)

    Secondary Outcome Measures

    OS
    Overall survival
    ORR
    The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
    DOR
    Duration of Overall Response.The date of the first assessed PR/CR (according to RECIST 1.1) to the date of the first assessed tumor progression (according to RECIST 1.1) or death from any cause.

    Full Information

    First Posted
    June 23, 2023
    Last Updated
    June 23, 2023
    Sponsor
    Fudan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05928780
    Brief Title
    An Umbrella Trial Based on Molecular Pathway for Patients With Metastatic TNBC in First-line Treatment (FUTURE-Trop2)
    Official Title
    A Molecular Pathway-based Umbrella Trial for First-line Precision Therapy With TROP2 in Patients With Locally Advanced or Metastatic TNBC (Future-Trop2 Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    March 1, 2024 (Anticipated)
    Study Completion Date
    September 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fudan University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To explore the efficacy and safety of TROP2 in the treatment of ABC
    Detailed Description
    To explore the efficacy and safety of advanced first-line TROP2 precision therapy in patients with locally advanced or metastatic triple-negative breast cancer based on molecular subtypes

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    TNBC - Triple-Negative Breast Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    125 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    LAR
    Arm Type
    Experimental
    Arm Description
    Coelomofacial androgen receptor
    Arm Title
    IM
    Arm Type
    Experimental
    Arm Description
    Immunoregulatory type
    Arm Title
    BLIS
    Arm Type
    Experimental
    Arm Description
    Basal type and immunosuppressive type
    Arm Title
    MES
    Arm Type
    Experimental
    Arm Description
    Interstitial type
    Intervention Type
    Drug
    Intervention Name(s)
    A1:SG with SHR3680
    Intervention Description
    SG 10mg/kg d1, 8;SHR3680 240mg qd,3 weeks is a cycle
    Intervention Type
    Drug
    Intervention Name(s)
    A2:SG
    Intervention Description
    SG 10mg/kg d1, 8
    Intervention Type
    Drug
    Intervention Name(s)
    B1:SG with SHR1210
    Intervention Description
    SG 10mg/kg, d1, 8;SHR1210 200mg,d1,q3w;
    Intervention Type
    Drug
    Intervention Name(s)
    B2:SG
    Intervention Description
    SG 10mg/kg, d1, 8
    Intervention Type
    Drug
    Intervention Name(s)
    C1:SG with SHR3162
    Other Intervention Name(s)
    Phase Ib dose ramp
    Intervention Description
    SG 10mg/kg d1, 8;SHR3162,150mg,QD ,3 weeks is a cycle
    Intervention Type
    Drug
    Intervention Name(s)
    C2:SG
    Intervention Description
    SG 10mg/kg d1, 8
    Intervention Type
    Drug
    Intervention Name(s)
    D1:SG with VEGFRI
    Other Intervention Name(s)
    Phase Ib dose ramp
    Intervention Description
    SG 10mg/kg,d1, 8;BP102 15mg/kg,d1,3 weeks is a cycle
    Intervention Type
    Drug
    Intervention Name(s)
    D2:SG
    Intervention Description
    SG 10mg/kg d1, 8
    Primary Outcome Measure Information:
    Title
    PFS
    Description
    time to progressive disease (according to RECIST1.1)
    Time Frame
    max 6 months
    Secondary Outcome Measure Information:
    Title
    OS
    Description
    Overall survival
    Time Frame
    max 6 months
    Title
    ORR
    Description
    The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
    Time Frame
    max 6 months
    Title
    DOR
    Description
    Duration of Overall Response.The date of the first assessed PR/CR (according to RECIST 1.1) to the date of the first assessed tumor progression (according to RECIST 1.1) or death from any cause.
    Time Frame
    max 6 months

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women ≥18 years old and ≤70 years old. ECOG body status level 0 ~ 1. The expected survival is not less than 3 months. Breast cancer patients with histologically proven invasive triple-negative breast cancer (specifically defined as estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER-2) who are all negative by pathological tests. Specifically: ER negative: IHC<1%, PR negative: IHC<1%, HER2 negative: IHC-/+ or IHC++ but FISH/CISH negative. All specimens should be verified by the pathology department of the research center, and the molecular typing of relapses and metastases should be re-checked. Tumor stage: recurrent or metastatic breast cancer; Patients with local recurrence need to be confirmed by the investigator that radical surgical resection is not possible. Stage II: patients who have not used paclitaxel or have used paclitaxel in adjuvant/neoadjuvant therapy, but the interval from the end of treatment to relapse is greater than 6 months; No systemic anti-tumor therapy (chemotherapy, targeted therapy, etc.) has been received in the advanced stage. Stage I: The advanced stage has received ≥1 line systemic anti-tumor therapy (chemotherapy, targeted therapy, etc.). Have at least one measurable lesion or unmeasurable lesion according to RECIST version 1.1 (measurable lesion ≥20mm conventional CT scan and ≥10mm spiral CT scan, measurable lesion not receiving radiotherapy). The functions of the main organs are basically normal. Have not received radiotherapy, endocrine therapy, molecular targeted therapy, or surgery (except for procedures unrelated to antitumor therapy such as central venous catheterization) within 3 weeks prior to the start of the study, and have recovered from acute toxic effects of previous treatment (if surgery is available, the wound has fully healed). No peripheral neuropathy or grade I peripheral neurotoxicity. Fertile female subjects are required to use a medically approved contraceptive during study treatment and for at least 3 months after the last use of the study drug; The subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up. Exclusion Criteria: Stage II: patients with adjuvant/neoadjuvant use of paclitaxel but the interval from the end of taxol treatment to recurrence and metastasis is less than 6 months, or have received systemic anti-tumor therapy (chemotherapy, targeted therapy, etc.) in the late stage; Stage I: no systemic anti-tumor therapy (chemotherapy, targeted therapy, etc.) has been received in the advanced stage; Patients with known central nervous system metastasis or history of central nervous system metastasis prior to screening. For patients with clinically suspected central nervous system metastasis, enhanced CT or enhanced Magnetic Resonance Imaging (MRI) must be performed within 28 days before the first dose to rule out central nervous system metastasis. A history of clinically significant or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction within the last 6 months, or ventricular arrhythmia; Persistent grade ≥1 adverse events due to previous treatment. The exception to this is hair loss or something the researchers believe should not be ruled out. Such cases should be clearly documented in the investigator's notes; Major surgery was performed within 3 weeks of the first course of trial treatment (except for minor outpatient surgery, such as placement of vascular access); Pregnant or lactating patients; Other malignancies within the previous 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or skin squamous cell carcinoma. Inability to swallow, chronic diarrhea and intestinal obstruction, there are multiple factors that affect drug use and absorption; There is a third space effusion that cannot be controlled by drainage or other methods (such as excessive pleural fluid and ascites); Participated in clinical trials of other antitumor drugs within 4 weeks before taking the study drug for the first time; long-term unhealed wounds or incomplete healing fractures; Patients with known HBV or HCV infection active phase or hepatitis B DNA≥500, or chronic phase with abnormal liver function; Allergic physique, or known allergic history of the drug components of this program; Or allergic to other monoclonal antibodies; Malignant tumors within the past five years (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).

    12. IPD Sharing Statement

    Learn more about this trial

    An Umbrella Trial Based on Molecular Pathway for Patients With Metastatic TNBC in First-line Treatment (FUTURE-Trop2)

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