Clinical trial NCT05444998: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Pathological complete response rate (pCR)
timeFrame: At the end of Cycle 1 (each cycle is 14 days)
Secondary outcomes:
measure: adverse effects
timeFrame: during the period of neadjuvant chemotherapy,an average of 4 weeks
Other outcomes:
Locations:
Study officials:
References: