Neoadjuvant Inituomab, Pyrrolidone and Nab-paclitaxel for HER2+Breast Cancer

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Intuzumab, pyrrolidone, nab-paclitaxel

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

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Meiling huang, PhD; Phone Number: 13109558202; Email: huangmeiling@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. female treatment-naive patients aged ≥ 18 years and ≤ 75 years;
2. ECOG score 0 ~ 1;
3. 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).
4. known hormone receptor status (ER and PgR);
5. 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:

1. stage IV (metastatic) breast cancer;
2. inflammatory breast cancer;
3. 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;
4. concurrent anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy;
5. Patients who have undergone major surgical procedures unrelated to breast cancer before enrollment, or have not fully recovered from such surgical procedures;
6. severe heart disease or discomfort
7. inability to swallow, intestinal obstruction, or other factors affecting drug administration and absorption;
8. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intuzumab + pyrrolidone + nab-paclitaxel; 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.

Drug: Intuzumab, pyrrolidone, nab-paclitaxel; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	At the end of Cycle 1 (each cycle is 14 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse effects	Serious adverse effect occur within neoadjuvant chemotherapy	during the period of neadjuvant chemotherapy,an average of 4 weeks

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: June 26, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: KY20222062-C-1

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