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Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer

Primary Purpose

Breast Cancer Stage I

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Capecitabine,Pyrotinib
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Stage I

Eligibility Criteria

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

Inclusion Criteria: Women aged 18-70; The pathology of early breast cancer after surgery is T1micN0: histologically confirmed that the longest diameter of invasive cancer does not exceed 1mm or the maximum diameter of multiple invasive lesions is less than 1mm, and the lymph node is negative (N0); The pathological type of immunohistochemistry needs to meet the following conditions: HER-2 (3+) or HER-2 (0-2+) but amplified by FISH detection. Hormone receptor negative (HR-) is defined as ER, PR expression is <1%; Hormone receptor positivity (HR+) is defined as ER and/or PR expression ≥1%. For patients with both invasive lesions, if both lesions are HER-2 positive, they can be enrolled. ECOG score≦ 1 point; No obvious dysfunction of major organs; Blood routine: ANC ≥1.5×109/L, PLT≥100×109/L, blood Hb≥ 9 g/dl (no transfusion within 14 days); Liver function: total bilirubin ≤1.25×ULN; AST and ALT <2.5×ULN; Renal function: creatinine clearance ≥ 50 mL/min, blood creatinine ≤ 1.5 ×ULN; Cardiac function: ECG is generally normal, QTc< 470 ms; LVEF > 50%; contraception during treatment for women of childbearing age; No history of other malignant tumors in the past 5 years; With the consent of the person and signed the informed consent form, or signed by the patient's legal representative with the authorization of the patient. Can be followed up and good compliance. Exclusion Criteria: The maximum size of the infiltrate is more than 1mm in diameter or the axillary lymph node is positive HER2 negative: immunohistochemical HER2-,+; Immunohistochemical HER2+ while FISH has no amplification; Patients who have received neoadjuvant therapy or any other form of systemic therapy or local therapy other than surgery, including chemotherapy, targeted, radiotherapy, or endocrine therapy, prior to enrollment History of other malignant tumors, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; Metastasis of any part; Pregnant or lactating women, women of childbearing age who cannot be effectively contraceptives; Patients who participate in other clinical trials at the same time; Severe organ function (heart, lung, liver and kidney) insufficiency, LEVF < 50% (ultracardiogram); severe cardiovascular and cerebrovascular diseases (such as: unstable angina, chronic heart failure, uncontrollable hypertension >150/90mmgh, myocardial infarction or cerebrovascular accident) within 6 months before enrollment; diabetics with poor glycemic control; Patients with severe hypertension; Severe or uncontrolled infection; Those who have a history of psychotropic substance abuse and cannot quit or have a history of mental disorders; Patients who are judged by the investigator to be unsuitable to participate in this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Arm-1

    Arm-2

    Arm Description

    Pyrotinib: 400mg QD Po for half a year, and Capecitabine: 500mg Tid Po for half a year Use of endocrine drugs in endocrine receptor (HR)-positive patients after chemotherapy. For premenopausal patients: tamoxifen (10 mg po, bid, for 5 years) or toremifene (60 mg po, qd, for 5 years); for postmenopausal patients: letrozole (2.5 mg, po, qd for 5 years) or anastrozole (1 mg, po, qd for 5 years) or exemestane (25 mg, po, qd for 5 years). After chemotherapy, radiation therapy will be started if necessary.

    No adjuvant chemotherapy or targeted therapy. Use of endocrine drugs in endocrine receptor (HR)-positive patients after chemotherapy. For premenopausal patients: tamoxifen (10 mg po, bid, for 5 years) or toremifene (60 mg po, qd, for 5 years); for postmenopausal patients: letrozole (2.5 mg, po, qd for 5 years) or anastrozole (1 mg, po, qd for 5 years) or exemestane (25 mg, po, qd for 5 years). After chemotherapy, radiation therapy will be started if necessary.

    Outcomes

    Primary Outcome Measures

    iDFS
    invasive disease-free survival

    Secondary Outcome Measures

    DDFS
    distant disease free survival
    OS
    overall survival

    Full Information

    First Posted
    May 7, 2023
    Last Updated
    May 7, 2023
    Sponsor
    Fudan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05861271
    Brief Title
    Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer
    Official Title
    Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    July 1, 2026 (Anticipated)
    Study Completion Date
    July 1, 2028 (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
    For patients with HER2-positive early-stage breast cancer, NCCN guidelines recommend chemotherapy plus targeted therapy as the standard adjuvant treatment for patients with tumors larger than 1 cm or lymph node-positive. The APT study enrolled patients with stage I HER2-positive breast cancer and has confirmed the efficacy and safety of intravenous chemotherapy combined with targeted therapy, but only 2.2% of the patients enrolled in microinvasion are enrolled, and there is a lack of large sample size data to provide a treatment reference for these patients. In order to further explore the optimal strategy for adjuvant therapy in this type of patient, we designed a new clinical trial to evaluate the efficacy and safety of oral capecitabine plus pyrotinib as adjuvant therapy in previous retrospective studies.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer Stage I

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1008 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm-1
    Arm Type
    Experimental
    Arm Description
    Pyrotinib: 400mg QD Po for half a year, and Capecitabine: 500mg Tid Po for half a year Use of endocrine drugs in endocrine receptor (HR)-positive patients after chemotherapy. For premenopausal patients: tamoxifen (10 mg po, bid, for 5 years) or toremifene (60 mg po, qd, for 5 years); for postmenopausal patients: letrozole (2.5 mg, po, qd for 5 years) or anastrozole (1 mg, po, qd for 5 years) or exemestane (25 mg, po, qd for 5 years). After chemotherapy, radiation therapy will be started if necessary.
    Arm Title
    Arm-2
    Arm Type
    No Intervention
    Arm Description
    No adjuvant chemotherapy or targeted therapy. Use of endocrine drugs in endocrine receptor (HR)-positive patients after chemotherapy. For premenopausal patients: tamoxifen (10 mg po, bid, for 5 years) or toremifene (60 mg po, qd, for 5 years); for postmenopausal patients: letrozole (2.5 mg, po, qd for 5 years) or anastrozole (1 mg, po, qd for 5 years) or exemestane (25 mg, po, qd for 5 years). After chemotherapy, radiation therapy will be started if necessary.
    Intervention Type
    Drug
    Intervention Name(s)
    Capecitabine,Pyrotinib
    Other Intervention Name(s)
    Pyrotinib
    Intervention Description
    Pyrotinib and Capecitabine for half a year
    Primary Outcome Measure Information:
    Title
    iDFS
    Description
    invasive disease-free survival
    Time Frame
    5 years
    Secondary Outcome Measure Information:
    Title
    DDFS
    Description
    distant disease free survival
    Time Frame
    5 years
    Title
    OS
    Description
    overall survival
    Time Frame
    5 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women aged 18-70; The pathology of early breast cancer after surgery is T1micN0: histologically confirmed that the longest diameter of invasive cancer does not exceed 1mm or the maximum diameter of multiple invasive lesions is less than 1mm, and the lymph node is negative (N0); The pathological type of immunohistochemistry needs to meet the following conditions: HER-2 (3+) or HER-2 (0-2+) but amplified by FISH detection. Hormone receptor negative (HR-) is defined as ER, PR expression is <1%; Hormone receptor positivity (HR+) is defined as ER and/or PR expression ≥1%. For patients with both invasive lesions, if both lesions are HER-2 positive, they can be enrolled. ECOG score≦ 1 point; No obvious dysfunction of major organs; Blood routine: ANC ≥1.5×109/L, PLT≥100×109/L, blood Hb≥ 9 g/dl (no transfusion within 14 days); Liver function: total bilirubin ≤1.25×ULN; AST and ALT <2.5×ULN; Renal function: creatinine clearance ≥ 50 mL/min, blood creatinine ≤ 1.5 ×ULN; Cardiac function: ECG is generally normal, QTc< 470 ms; LVEF > 50%; contraception during treatment for women of childbearing age; No history of other malignant tumors in the past 5 years; With the consent of the person and signed the informed consent form, or signed by the patient's legal representative with the authorization of the patient. Can be followed up and good compliance. Exclusion Criteria: The maximum size of the infiltrate is more than 1mm in diameter or the axillary lymph node is positive HER2 negative: immunohistochemical HER2-,+; Immunohistochemical HER2+ while FISH has no amplification; Patients who have received neoadjuvant therapy or any other form of systemic therapy or local therapy other than surgery, including chemotherapy, targeted, radiotherapy, or endocrine therapy, prior to enrollment History of other malignant tumors, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; Metastasis of any part; Pregnant or lactating women, women of childbearing age who cannot be effectively contraceptives; Patients who participate in other clinical trials at the same time; Severe organ function (heart, lung, liver and kidney) insufficiency, LEVF < 50% (ultracardiogram); severe cardiovascular and cerebrovascular diseases (such as: unstable angina, chronic heart failure, uncontrollable hypertension >150/90mmgh, myocardial infarction or cerebrovascular accident) within 6 months before enrollment; diabetics with poor glycemic control; Patients with severe hypertension; Severe or uncontrolled infection; Those who have a history of psychotropic substance abuse and cannot quit or have a history of mental disorders; Patients who are judged by the investigator to be unsuitable to participate in this study.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer

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