Clinical Study of Pyrotinib in Neoadjuvant Therapy of HR-positive and HER2-positive Breast Cancer

NCT05430347 | Unknown Phase 2

• 1 other identifier: Pyrotinib neoadjuvant
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Due to neoadjuvant therapy with trastuzumab and pertuzumab is less effective for HR+/HER2+ breast cancer, and the PHEDRA Clinical Study subgroup analysis showed that the addition of pyrotinib to trastuzumab more than doubled pCR rates in HR+/HER2+ patients. our research group proposed a hypothesis that pyrotinib may be more advantageous for HR+/HER2+ breast cancer. Therefore, our center intends to carry out a multi-center, randomized controlled, prospective clinical study to compare the efficacy of pyrotinib or pertuzumab combined with docetaxel, carboplatin and trastuzumab in neoadjuvant therapy for patients with HR+/HER2+ breast cancer, and to conduct a comparative study on the safety.

Conditions

Breast Cancer

Keywords

HR+/HER2+ Breast cancer; Neoadjuvant therapy; pyrotinib

Outcome Measures

Primary Outcomes (1)

• tpCR rate (ypT0/is ypN0)

  Pathological complete response rate after neoadjuvant ( both breast and axillary lymph nodes, in which the breast may have residual carcinoma in situ)

  1 month after surgery

Secondary Outcomes (2)

• iDFS

  3 years

• EFS

  3 years

Study Arms (2)

TCbHPy*6

EXPERIMENTAL

Pyrotinib combined with docetaxel, carboplatin and trastuzumab for 6 cycles (Every three weeks). T (Docetaxel 100 mg/m2, d1) C (Carboplatin, AUC 6, D1) H (Trastuzumab, 8 mg/kg for the first dose, 6 mg/kg for the rest, D1) Py (pyrotinib 400mg, qD, D1-21)

Combination Product: Neoadjuvant therapy: TCbHPy

TCbHP*6

ACTIVE COMPARATOR

Pertuzumab combined with docetaxel, carboplatin and trastuzumab for 6 cycles (Every three weeks). T (Docetaxel 100 mg/m2, d1) C (Carboplatin, AUC 6, D1) H (Trastuzumab, 8 mg/kg for the first dose, 6 mg/kg for the rest, D1) P (Pertuzumab, 840mg for the first dose, 420mg for the rest, D1))

Combination Product: Neoadjuvant therapy: TCbHP

Interventions

Neoadjuvant therapy: TCbHPy COMBINATION_PRODUCT

Pyrotinib combined with docetaxel, carboplatin and trastuzumab (TCbHPy) for neoadjuvant therapy of HR+/HER2+ breast cancer

TCbHPy*6

Neoadjuvant therapy: TCbHP COMBINATION_PRODUCT

Pertuzumab combined with docetaxel, carboplatin and trastuzumab (TCbHP) for neoadjuvant therapy of HR+/HER2+ breast cancer

TCbHP*6

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18-70 with breast cancer;
• Pathologically confirmed unilateral invasive ductal carcinoma (with or without intraductal carcinoma components);
• Proposed to receive neoadjuvant therapy;
• Positive ER and/or PgR (defined as ≥10% positive immunohistochemical test);
• HER2 positive (defined as IMMUNOHISTOchemical HER2 ++, or HER2 ++ and in situ hybridization (ISH) results in HER2 gene amplification);
• There is no evidence of metastasis in clinical or imaging;
• ECOG score 0 or 1;
• White blood cell count ≥3.5×109/L, neutrophil count ≥2×109/L, platelet count ≥100×109/L and hemoglobin ≥90 g/L before neoadjuvant therapy;
• Before neoadjuvant therapy, AST and ALT \< 1.5 times the upper limit of normal value, alkaline phosphatase \< 2.5 times the upper limit of normal value, total bilirubin \< 1.5 times the upper limit of normal value; Serum creatinine \< 1.5 times the upper limit of normal value;
• LVEF≥55% on 2d echocardiography before neoadjuvant therapy;
• Signed informed consent.

You may not qualify if:

• Clinical or imaging suspicion of lateral breast malignancy has not been confirmed;
• Prior malignancy (except basal cell carcinoma of the skin and carcinoma in situ of the cervix), including contralateral breast cancer;
• The patient has been enrolled in other clinical trials;
• Patients suffering from serious systemic diseases and/or uncontrollable infections cannot be enrolled in the study;
• Severe cardiovascular and cerebrovascular diseases (e.g., unstable angina pectoris, chronic heart failure, uncontrolled hypertension \> 150/90mmHg, myocardial infarction or cerebrovascular accident) within the first 6 months of randomization;
• Have a history of blood system diseases, especially platelet-related diseases;
• Patients with previous intestinal inflammation, intestinal dysfunction, severe diarrhea and constipation;
• People who are known to be allergic to chemotherapy drugs, targeted drugs or TKI drugs;
• Women of childbearing age refuse contraception during treatment and within 8 weeks after completion of treatment;
• Pregnant and lactation women;
• positive pregnancy test before drug use after joining the test;
• Mental illness, cognitive impairment, inability to understand the test protocol and side effects, inability to complete the test protocol and follow-up workers (systematic evaluation is required before the trial is enrolled);
• Persons without personal freedom and independent capacity for civil conduct.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jue Wang, Doctor

CONTACT

+86-18061695508; wangjue200011@163.com

Rui Chen, Master

CONTACT

+86-15951756315; 15951756315@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study is an open-design, multicenter, randomized controlled prospective clinical study with 80 patients. Subjects will be randomly assigned 1:1.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The treatment regimen of the experimental group was pyrotinib combined with docetaxel, carboplatin and trastuzumab, while the treatment regimen of the control group was pertuzumab combined with docetaxel, carboplatin and trastuzumab (the control group was standard treatment). Surgical treatment was performed after 6 courses of neoadjuvant therapy

Study Record Dates

• First Submitted: June 12, 2022
• First Posted: June 24, 2022
• Study Start: April 15, 2023
• Primary Completion: June 15, 2025
• Study Completion: September 30, 2025
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)