Back to resultsNeoadjuvant Inituomab, Pyrrolidone and Nab-paclitaxel for HER2+Breast Cancer
Primary Purpose
Breast Cancer
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Intuzumab, pyrrolidone, nab-paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- female treatment-naive patients aged ≥ 18 years and ≤ 75 years;
- ECOG score 0 ~ 1;
- HER2-positive breast cancer confirmed by pathological examination, defined as an immunohistochemical (IHC) score of 3 + in > 10% of immunoreactive cells or HER2 gene amplification by in situ hybridization (ISH) results (HER2 gene signal to centromere 17 signal ratio ≥ 2.0 or HER2 gene copy number ≥ 6).
- known hormone receptor status (ER and PgR);
- The functional level of major organs must meet the following requirements (no blood transfusion, no leukocyte-elevating and platelet-elevating drugs are used 2 before screening):
1) Blood routine neutrophil (ANC) ≥ 1.5 × 109/L; platelet count (PLT) ≥ 90 × 109/L; hemoglobin (Hb) ≥ 90 g/L; 2) Blood biochemical total bilirubin (TBIL) ≤ upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; 3) echocardiography score (LVEF) ≥ 55%; 4) 12 ECG Fridericia-corrected QT interval (QTcF) < 470 msec; 6. For premenopausal or non-surgically sterile female patients: agree to abstain from sexual intercourse or use effective contraceptive methods during treatment and for at least 7 months after the last dose of the study treatment.
7. Voluntarily join this study, sign the informed consent form, have good compliance and are willing to cooperate with the follow-up.
Exclusion Criteria:
- stage IV (metastatic) breast cancer;
- inflammatory breast cancer;
- Previous anti-tumor therapy or radiotherapy for any malignant tumor, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma and other malignant tumors;
- concurrent anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy;
- Patients who have undergone major surgical procedures unrelated to breast cancer before enrollment, or have not fully recovered from such surgical procedures;
- severe heart disease or discomfort
- inability to swallow, intestinal obstruction, or other factors affecting drug administration and absorption;
- known to have a history of allergy to the drug components of this protocol: a history of immunodeficiency, including HIV test positive, or suffering from other acquired, congenital immunodeficiency diseases, or a history of organ transplantation; 9. pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test, or patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial and within 7 months after the study;
10. suffering from serious concomitant diseases or other diseases that will interfere with the planned treatment of concomitant diseases, or any other conditions that the investigator believes that the patient is not suitable for this study
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intuzumab + pyrrolidone + nab-paclitaxel
Arm Description
Pyrrolidone 400 mg, qd; nab-paclitaxel 125 mg/m2, qw, D1/8/15; inituzumab 6 mg/kg (first dose 8 mg/kg) q3w, D1; 4 cycles in total (q3w as 1 cycle). postoperative adjuvant therapy:4 cycles of epirubicin + cyclophosphamide + physician's choice of anti-HER2 targeted therapy.
Outcomes
Primary Outcome Measures
Pathological complete response rate (pCR)
absence of invasive carcinoma in the breast and axillary lymph nodes, while residual ductal carcinoma in situ was accepted (ypT0orTisypN0)
Secondary Outcome Measures
adverse effects
Serious adverse effect occur within neoadjuvant chemotherapy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05444998
Brief Title
Neoadjuvant Inituomab, Pyrrolidone and Nab-paclitaxel for HER2+Breast Cancer
Official Title
A Prospective, Open-label, Single-arm Phase II Study of Neoadjuvant Ertuzumab Combined With Pyrrolidone and Nab-paclitaxel in Patients With HER2-positive Early and Locally Advanced Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2022 (Anticipated)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
explore the efficacy and safety of the combination of nintedanib and paclitaxel in the neoadjuvant treatment of HER2 positive early or locally advanced breast cancer
Detailed Description
This study is a prospective, open-label, single-arm clinical study, and it is planned to include 20 treatment-naive patients with HER2-positive early or locally advanced breast cancer (clinical stage IIA ~ IIIC). Neoadjuvant treatment regimen was nituximab + pyrrolidine + nab-paclitaxel. To explore the efficacy and safety of the combination of nintedanib and paclitaxel in the neoadjuvant treatment of HER2 positive early or locally advanced breast cancer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intuzumab + pyrrolidone + nab-paclitaxel
Arm Type
Experimental
Arm Description
Pyrrolidone 400 mg, qd; nab-paclitaxel 125 mg/m2, qw, D1/8/15; inituzumab 6 mg/kg (first dose 8 mg/kg) q3w, D1; 4 cycles in total (q3w as 1 cycle).
postoperative adjuvant therapy:4 cycles of epirubicin + cyclophosphamide + physician's choice of anti-HER2 targeted therapy.
Intervention Type
Drug
Intervention Name(s)
Intuzumab, pyrrolidone, nab-paclitaxel
Intervention Description
Pyrrolidone 400 mg, qd; nab-paclitaxel 125 mg/m2, qw, D1/8/15; inituzumab 6 mg/kg (first dose 8 mg/kg) q3w, D1; 4 cycles in total (q3w as 1 cycle).
The patient's postoperative adjuvant therapy was 4 cycles of epirubicin + cyclophosphamide + physician's choice of anti-HER2 targeted therapy.
Multiple drug interruptions for adverse events were allowed throughout.
Primary Outcome Measure Information:
Title
Pathological complete response rate (pCR)
Description
absence of invasive carcinoma in the breast and axillary lymph nodes, while residual ductal carcinoma in situ was accepted (ypT0orTisypN0)
Time Frame
At the end of Cycle 1 (each cycle is 14 days)
Secondary Outcome Measure Information:
Title
adverse effects
Description
Serious adverse effect occur within neoadjuvant chemotherapy
Time Frame
during the period of neadjuvant chemotherapy,an average of 4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
female treatment-naive patients aged ≥ 18 years and ≤ 75 years;
ECOG score 0 ~ 1;
HER2-positive breast cancer confirmed by pathological examination, defined as an immunohistochemical (IHC) score of 3 + in > 10% of immunoreactive cells or HER2 gene amplification by in situ hybridization (ISH) results (HER2 gene signal to centromere 17 signal ratio ≥ 2.0 or HER2 gene copy number ≥ 6).
known hormone receptor status (ER and PgR);
The functional level of major organs must meet the following requirements (no blood transfusion, no leukocyte-elevating and platelet-elevating drugs are used 2 before screening):
1) Blood routine neutrophil (ANC) ≥ 1.5 × 109/L; platelet count (PLT) ≥ 90 × 109/L; hemoglobin (Hb) ≥ 90 g/L; 2) Blood biochemical total bilirubin (TBIL) ≤ upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; 3) echocardiography score (LVEF) ≥ 55%; 4) 12 ECG Fridericia-corrected QT interval (QTcF) < 470 msec; 6. For premenopausal or non-surgically sterile female patients: agree to abstain from sexual intercourse or use effective contraceptive methods during treatment and for at least 7 months after the last dose of the study treatment.
7. Voluntarily join this study, sign the informed consent form, have good compliance and are willing to cooperate with the follow-up.
Exclusion Criteria:
stage IV (metastatic) breast cancer;
inflammatory breast cancer;
Previous anti-tumor therapy or radiotherapy for any malignant tumor, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma and other malignant tumors;
concurrent anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy;
Patients who have undergone major surgical procedures unrelated to breast cancer before enrollment, or have not fully recovered from such surgical procedures;
severe heart disease or discomfort
inability to swallow, intestinal obstruction, or other factors affecting drug administration and absorption;
known to have a history of allergy to the drug components of this protocol: a history of immunodeficiency, including HIV test positive, or suffering from other acquired, congenital immunodeficiency diseases, or a history of organ transplantation; 9. pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test, or patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial and within 7 months after the study;
10. suffering from serious concomitant diseases or other diseases that will interfere with the planned treatment of concomitant diseases, or any other conditions that the investigator believes that the patient is not suitable for this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meiling huang, PhD
Phone
13109558202
Email
huangmeiling@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neoadjuvant Inituomab, Pyrrolidone and Nab-paclitaxel for HER2+Breast Cancer
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