Pyrotinib in HER2-positive Early Breast Cancer

NCT06718335 | Not Yet Recruiting

• 1 other identifier: OBU-BC-YUNNAN-001
• Study Type: interventional
• Target: 156
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Multi-cohort, Phase II Clinical Study of Neoadjuvant - Adjuvant Pyrotinib in the Treatment of HER2-positive Early Breast Cancer, To evaluate the efficacy and safety of the pyrotinib-containing study regimen in patients with early HER2-positive early breast cancer with neoadjuvant and postoperative different Residual tumor burden (RCB) scores.

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Event Free Survival(EFS)

  Event Free Survival

  3 year

Secondary Outcomes (1)

• total pathological complete response(tpCR)

  24 month

Study Arms (3)

Pyrotinib

EXPERIMENTAL

Patients who meet the screening criteria will receive pyrotinib (400mg, qd) + trastuzumab injection (first dose 8mg/kg, subsequent 6mg/kg, d1) + albumin purpurenin (125mg/m2, d1, d8) + carboplatin (AUC=6, d1) for 21 days/cycle for a total of 6 cycles of neoadjuvant therapy. One month after the end of neoadjuvant therapy, patients should receive radical mastectomy (breast-conserving surgery or total mastectomy), if the postoperative pathological complete response patients receive pyrotinib (400mg, qd) for one year,. If patients were hormone receptor positive patients at the adjuvant treatment stage, the endocrine treatment regimen was selected by the investigators.

Drug: Pyrotinib

T-DM1

EXPERIMENTAL

Patients who meet the screening criteria will receive pyrotinib (400mg, qd) + trastuzumab injection (first dose 8mg/kg, subsequent 6mg/kg, d1) + albumin purpurenin (125mg/m2, d1, d8) + carboplatin (AUC=6, d1) for 21 days/cycle for a total of 6 cycles of neoadjuvant therapy. One month after the end of neoadjuvant therapy, patients should receive radical mastectomy (breast-conserving surgery or total mastectomy), if the postoperative non-pathological complete response patients with RCB-1 receive Trastuzumab Emtansine (3.6 mg/kg, iv) for one year. If patients were hormone receptor positive patients at the adjuvant treatment stage, the endocrine treatment regimen was selected by the investigators.

Drug: Pyrotinib

T-DM1 and pertuzumab

EXPERIMENTAL

Patients who meet the screening criteria will receive pyrotinib (400mg, qd) + trastuzumab injection (first dose 8mg/kg, subsequent 6mg/kg, d1) + albumin purpurenin (125mg/m2, d1, d8) + carboplatin (AUC=6, d1) for 21 days/cycle for a total of 6 cycles of neoadjuvant therapy. One month after the end of neoadjuvant therapy, patients should receive radical mastectomy (breast-conserving surgery or total mastectomy), if the postoperative non-pathological complete response patients with RCB≥2 were treated with Trastuzumab Emtansine (3.6 mg/kg, iv) combined with pertuzumab for one year. If patients were hormone receptor positive patients at the adjuvant treatment stage, the endocrine treatment regimen was selected by the investigators.

Drug: Pyrotinib

Interventions

Pyrotinib DRUG

Patients who meet the screening criteria will receive pyrotinib (400mg, qd) + trastuzumab injection (first dose 8mg/kg, subsequent 6mg/kg, d1) + albumin purpurenin.In adjuvant therapy, pathological complete response patients receive pyrotinib time to one year, non-pathological complete response patients with RCB-1 receive Trastuzumab Emtansine time to one year，RCB≥2 were treated with Trastuzumab Emtansine combined with pertuzumab time to one year.

Pyrotinib; T-DM1; T-DM1 and pertuzumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged ≥18 years and ≤75 years with newly treated breast cancer;
• Pathological examination confirmed HER2 positive (immunohistochemistry staining +++ or immunohistochemistry staining ++ and Fluorescence in situ hybridization positive);
• Patients with invasive breast cancer diagnosed histologically plus imaging as early (T1c-3, N0-1, M0) or locally advanced (T2-3, N2, or N3, M0);
• Eastern Cooperative Oncology Group score 0\~1;
• Plan to undergo the final surgical removal of breast cancer, i.e. breast conserving surgery or total mastectomy, sentinel lymph node (SN) biopsy or axillary lymph node dissection (ALND);
• If the major organs function normally, the following criteria are met:
• (1) The standard of blood routine examination should meet: absolute neutrophil count(ANC) ≥1.5×109/L; blood platelet (PLT) ≥90×109/L; Hb ≥90g/L; (2) Biochemical examination should meet the following criteria: total bilirubin(TBIL)≤ upper limit of normal value (ULN); alanine aminotransferase(ALT) and AST≤1.5 times the upper limit of normal (ULN); Alkaline phosphatase ≤2.5 times the upper limit of normal (ULN); blood urea nitrogen(BUN)and Cr≤1.5×ULN and creatinine clearance ≥50 mL/min (CockcroftGault formula); (3) Color Doppler ultrasonography and echocardiography: left ventricular ejection fraction (LVEF≥55%); (4) Fridericia calibrated QT interval (QTcF) for 18-lead ECG \<470 ms; 7. For female patients who are not menopausal or have not been surgically sterilized: consent to abstinence or use of an effective contraceptive method during treatment and for at least 7 months after the last dose in the study treatment; 8. Volunteer to join the study and sign the informed consent.

You may not qualify if:

• Known allergic history of the drug components of this protocol;
• Previously received antitumor therapy or radiation therapy for any malignant tumor (except for cured cervical carcinoma in situ and basal cell carcinoma);
• Has undergone major non-breast cancer related surgery within 4 weeks, or has not fully recovered from such surgery;
• Stage IV (metastatic) breast cancer patients;
• Inability to swallow, intestinal obstruction, or other factors affecting the administration and absorption of the drug;
• Serious heart disease or discomfort that cannot be treated;
• Suffering from mental illness or psychotropic substance abuse, unable to cooperate;
• Pregnant or lactating women;
• Patients with severe liver and kidney function diseases and blood system diseases;

Sponsors & Collaborators

• Nie Jianyun: lead

MeSH Terms

Interventions

pyrotinib

Central Study Contacts

Nie Jian Yun, Ph.D

CONTACT

13608815577; njyvip@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nie jianyun,MD

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: December 5, 2024
• Study Start: December 30, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2029
• Last Updated: December 11, 2024

Record last verified: 2024-12