Pyrotinib and Subcutaneous Preparation of Trastuzumab Combined With Capecitabine Neoadjuvant Therapy for HER2+ Study of Breast Cancer

NCT06483386 | Not Yet Recruiting Phase 2

• 1 other identifier: Tianjin Cancer Hospital .
• Study Type: interventional
• Target: 109
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective: To explore the efficacy and safety of Pyrotinib, trastuzumab subcutaneous preparation and capecitabine neoadjuvant therapy for early HER2+breast cancer. Administration method: 6 cycles throughout the entire process: Pyrotinib Maleate Tablets: Continuously administered from the first day of the first course of treatment, 400 Mg/day, orally administered within 30 minutes after breakfast Trastuzumab: Subcutaneous injection, 600mg, d1, q3w Capecitabine: oral, 1000 mg/m2, bid d1-14, q3w Premenopausal goserelin 3.6mg once every 28 days

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Follow up on postoperative pathological reports for evaluation for Pathological complete response rate (tpCR: ypT0-is/ypN0)

  Follow up on postoperative pathological reports for evaluation rely onMiller\&Payne principles

  18weeks

Secondary Outcomes (1)

• Objective response rate (ORR) for treatment

  At the end of the second cycle (each cycle is 21 or 28 days)]

Study Arms (1)

Treatment group

EXPERIMENTAL

Pyrotinib Maleate Tablets: Continuously administered from day 1 of the first course of treatment, 400 Mg/day, orally administered within 30 minutes after breakfast Trastuzumab: Subcutaneous injection, 600mg, d1, q3w Capecitabine: oral, 1000 mg/m2 , bid d1-14,q3w Premenopausal goserelin 3.6mg once every 28 days

Drug: Pyrotinib and Subcutaneous preparation of trastuzumab combined with capecitabine

Interventions

Pyrotinib and Subcutaneous preparation of trastuzumab combined with capecitabine DRUG

Pyrotinib and Subcutaneous preparation of trastuzumab combined with capecitabine

Treatment group

Eligibility Criteria

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

You may qualify if:

• Age: Female first-time patients aged 18 and above;
• Pathological examination confirmed HER2 positive invasive breast cancer; (HER2 positive definition) Further application of in situ hybridization (ISH) for immunohistochemistry (IHC) 3+or IHC 2+HER2 gene amplification, regardless of hormone receptor status (ER and PR);
• According to the eighth edition of AJCC, the staging is T1c-2N0-1M0, and according to Recipe 1.1, there are At least one measurable lesion;
• ECOG PS: 0-1 points;
• The main organ function is normal, which meets the following standards:
• \) The standard for blood routine examination must comply with (no blood transfusion or blood products within 14 days, no use of G-CSF) Correction of other hematopoietic stimulating factors:Hb≥100g/L ;ANC≥1.5×109/L；PLT≥100×109/L；2) Biochemical examination must meet the following standards:TBIL≤1×ULN； ALT, AST ≤ 1.5 × ULN; ALP≤2.5×ULN； BUN and Cr ≤ 1.5 × ULN;3) Cardiac ultrasound:Left ventricular ejection fraction (LVEF) ≥ 55%; 6. Women of childbearing age must undergo a pregnancy test (serum) within 7 days before enrollment, and the result is negative Sexual and willing to use appropriate medication during the trial period and within 8 weeks after the last administration of the investigational drug The method of contraception; 7. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.

You may not qualify if:

• Have received any form of anti-tumor treatment in the past (chemotherapy, radiotherapy, molecular targeted therapy,...)Endocrine therapy, etc;
• Simultaneously receiving any other anti-tumor treatment;
• Bilateral breast cancer, inflammatory breast cancer or occult breast cancer;
• breast cancer not confirmed by histopathology;
• Other malignant tumors have appeared within the past 5 years, except for cured cervical cancer in situ;
• Severe dysfunction of important organs such as heart, liver, and kidney;
• Unable to swallow, chronic diarrhea, and intestinal obstruction, there are various factors that affect medication administration and absorption factor;
• Participated in clinical trials of other drugs within 4 weeks prior to enrollment;
• Individuals with a known history of allergies to the drug components of this protocol; History of immunodeficiency, including HIV Test positive, HCV, active hepatitis B, or other acquired diseases Natural immunodeficiency disease or a history of organ transplantation;
• Have ever suffered from any heart disease, including: (1) those that require medication or have clinical significance Arrhythmias; (2) Myocardial infarction; (3) Heart failure; (4) Any researcher Other heart diseases deemed unsuitable for participation in this trial;
• Pregnant and lactating female patients with fertility and positive baseline pregnancy test results Female patients of childbearing age who are unwilling to take effective contraceptive measures throughout the entire trial period Female patients;
• According to the researcher's judgment, there is a serious threat to patient safety or an impact on patient completion of the study The accompanying diseases studied (including but not limited to severe hypertension that cannot be controlled by medication, severe Diabetes, active infection, etc.);
• Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia. Researchers believe that Any other circumstances in which the patient is not suitable to participate in this study.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pyrotinib; Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Xue Jing Liu Xue Jing Liu

CONTACT

86-022-23340123; lxj8109@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: July 3, 2024
• Study Start: July 15, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share