Pyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer

• Sponsor: Youzhi Zhu (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06035679
• Collaborator: (none)
• Enrollment: 30
• Arm: 1
• Anticipated Duration (Months): 38.3

Study Details

Study Description

Brief Summary

This study is a prospective, single-center, observational clinical study, The objection was to observe the treatment of pyrotinib combined with trastuzumab and neoadjuvant chemotherapy Efficacy of Stage II-III breast cancer and observation of the efficacy of step-down neoadjuvant therapy for HER2-positive stage T1cN0M0 breast cancer.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Female	Drug: Pyrotinib and Trastuzumab	N/A

Detailed Description

This study is a prospective, single-center, observational clinical study,Which plan to be enroll 30 patients with HER2-positive early breast cancer receive pyrotinib combined with trastuzumab and chemotherapy neoadjuvant therapy. The primary endpoint was the total pathological complete response rate (tpCR) , The objection was to observe the treatment of pyrotinib combined with trastuzumab and neoadjuvant chemotherapy Efficacy of Stage II-III breast cancer and observation of the efficacy of step-down neoadjuvant therapy for HER2-positive stage T1cN0M0 breast cancer.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective, Single-center, Observational Clinical Study of Pyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer
• Anticipated Study Start Date: Sep 20, 2023
• Anticipated Primary Completion Date: Nov 30, 2026
• Anticipated Study Completion Date: Nov 30, 2026

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Pyrotinib Combined With Trastuzumab and Chemotherapy T1cN0M0 HER2+ breast cancer Patients received 2 cycles (pyrotinib + trastuzumab + taxoid) regimen and were evaluated to continue with the original regimen if PR, and 4 cycles (pyrotinib + trastuzumab + taxoid + carboplatin) regimen if SD/PD. Phase II-III HER2+ breast cancer Patients received 6 cycles of treatment (pyrotinib + trastuzumab + taxoid + carboplatin)

Drug: Pyrotinib and Trastuzumab; Small and large molecules combined with chemotherapy for neoadjuvant treatment of HER2-positive breast cancer; Other Names: dual HER2 blockade in the neoadjuvant setting

Outcome Measures

Primary Outcome Measures

1. tpCR [at surgery]

   total Pathological Complete Response

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Female patients aged 18-75 years;

2. Her2-positive breast cancer confirmed by pathology;

3. invasive breast cancer confirmed by histology, Tumor stage: early stage (T1c-3, N0-1, M0) or locally advanced stage (T2-4, N2, N3, M0);

4. ECOG PS: 0-1 score;

5. 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)

6. Normal function of major organs means that the following criteria are met:

(1) Blood test neutrophil (ANC) >=1.5x10^{9/L; Platelet count (PLT) >=90x10}9/L; Hemoglobin (Hb) >=90g/L; (2) Total bilirubin (TBIL) <=1.5 upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=1.5xULN; Alkaline phosphatase <=2.5xULN; Urea nitrogen (BUN) and creatinine (Cr) <=1.5xULN; (3) Left ventricular ejection fraction (LVEF) >=55%; (4) The QT interval (QTcF) corrected by Fridericia method was less than 470msec in 12-lead ECG; 7. For women who have not undergone menopause or surgical sterilization: consent to abstinence or use an effective contraceptive method (during treatment and for at least 7 months after the last dose in the study treatment); 8. Volunteer to participate in this study, sign the informed consent, have good compliance and be willing to cooperate with follow-up.

Exclusion Criteria:

1. Known allergic history of the drug components of this protocol;

2. Previous or co-existing other malignant tumors, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;

3. Participated in clinical trials of other antitumor drugs within four weeks;

4. Stage IV (metastatic) breast cancer;

5. Multiple factors affecting oral medication (e.g., inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction);

6. A history of congestive heart failure (CHF) or uncontrolled heart disease (angina, arrhythmia, hypertension);

7. Patients with active infection and severe mental illness;

8. Pregnant or lactating patients;

9. Patients with allergies or known history of allergies to the drug components of this protocol; A history of immunodeficiency, including being HIV positive, or having other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;

10. Concomitant diseases that, in the judgment of the investigator, seriously endanger the patient's safety or interfere with the patient's completion of the study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Youzhi Zhu

Investigators

• Study Chair: zhu youzhi, First Affiliated Hospital of Fujian Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Youzhi Zhu, Clinical Professor, First Affiliated Hospital of Fujian Medical University
• ClinicalTrials.gov Identifier: NCT06035679
• Other Study ID Numbers: OBU-BC-II-95
• First Posted: Sep 13, 2023
• Last Update Posted: Sep 13, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms; Trastuzumab

Study Results

No Results Posted as of Sep 13, 2023