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

• ClinicalTrials.gov Identifier: NCT06035679
• Recruitment Status: Recruiting
• First Posted: September 13, 2023
• Last Update Posted: February 28, 2024
• Sponsor: Youzhi Zhu
• Information provided by (Responsible Party): Youzhi Zhu, First Affiliated Hospital of Fujian Medical University

Tracking Information

• First Submitted Date: August 31, 2023
• First Posted Date: September 13, 2023
• Last Update Posted Date: February 28, 2024
• Actual Study Start Date: August 17, 2023
• Estimated Primary Completion Date: November 30, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 11, 2023)

tpCR [ Time Frame: at surgery ]

total Pathological Complete Response

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer
• Official Title: Prospective, Single-center, Observational Clinical Study of Pyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer
• 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.
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Breast Cancer Female

Intervention

Drug: Pyrotinib and Trastuzumab

Small and large molecules combined with chemotherapy for neoadjuvant treatment of HER2-positive breast cancer

Other Name: dual HER2 blockade in the neoadjuvant setting

Study Arms

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)

Intervention: Drug: Pyrotinib and Trastuzumab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 11, 2023): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 30, 2026
• Estimated Primary Completion Date: November 30, 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: zhu youzhi; 17759120588; zhu@fjmu.edu.cn

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT06035679
• Other Study ID Numbers: OBU-BC-II-95
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: There is not a plan to make IPD available

• Current Responsible Party: Youzhi Zhu, First Affiliated Hospital of Fujian Medical University
• Original Responsible Party: Same as current
• Current Study Sponsor: Youzhi Zhu
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: First Affiliated Hospital of Fujian Medical University
• Verification Date: September 2023