Breast Cancer Clinical Trial
Official title:
A Randomized, Open-label, Multicenter Study Comparing Continuation of Original Targeted Therapy With Trastuzumab Combined With Pyrotinib and Capecitabine as Postoperative Adjuvant Therapy in Non-pCR Patients With HER2 Positive Early Breast Cancer
To evaluate the efficacy of continuation targeted therapy compared with trastuzumab combined with Pyrotinib and capecitabine in postoperative adjuvant therapy of HER-2 positive early breast cancer patients with residual tumor (primary breast tumor/axillary lymph nodes) who did not achieve pCR after neoadjuvant therapy
Status | Recruiting |
Enrollment | 206 |
Est. completion date | December 31, 2027 |
Est. primary completion date | October 1, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Female patients aged = 18 years and = 75 years old with primary breast cancer - ECOG score 0 ~ 1 - Breast cancer meets the following criteria: 1)Histologically or pathologically confirmed invasive breast cancer, primary tumor stage determined by standard evaluation methods:cT1-4/N0-3/M0. 2)Pathologically confirmed HER2-expressing positive breast cancer, defined as > 10% immunoreactive cells with immunohistochemical (IHC) score of 3 + or in situ hybridization (ISH) results of HER2 gene amplification. 3)Known hormone receptor status (ER and PgR). 4)Neoadjuvant therapy (including: at least 9 weeks of trastuzumab treatment and at least 9 weeks of taxane chemotherapy) - Primary breast cancer lesion or lymph node invasive cancer confirmed by pathology after neoadjuvant therapy (residual invasive breast cancer lesion > 2 cm or axillary lymph node positive with macrometastasis assessed by central laboratory) - No more than 12 weeks between end of surgery (without post-operative radiotherapy) and randomisation or 6 weeks between end of post-operative radiotherapy and randomisation - Required laboratory values including following parameters: ANC: = 1.5 x 109/L Platelet count: = 90 x 109/L Hemoglobin: = 9.0 g/dL Total bilirubin: = 1.5 x upper limit of normal, ULN ALT and AST: = 1.5 x ULN BUN and creatine clearance rate: = 50 mL/min LVEF: = 55% QTcF: < 470 ms Exclusion Criteria: - 1) Stage IV (metastatic) breast cancer; - 2) inflammatory breast cancer; - 3) Previous anti-tumor therapy or radiotherapy for any malignancy, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma; - 4) Receiving anti-tumor therapy in other clinical trials, including bisphosphonate therapy or immunotherapy (except radiotherapy and endocrine therapy during treatment); - 5) Receiving any anti-tumor therapy within 28 days before enrollment; - 6) Peripheral neuropathy = Grade 2 as specified by NCI CTCAE; - 7) Receiving pyrrolidone or other anti-HER2 tyrosine kinase inhibitors; - 8) Receiving anthracycline therapy with cumulative doses as follows: adriamycin > 240 mg/m2, epirubicin > 480 mg/m2; - 9) Receiving major surgery unrelated to breast cancer before randomization, or the patient has not fully recovered from surgery |
Country | Name | City | State |
---|---|---|---|
China | Fujian Medical University Union Hospital | Fuzhou | Fujian |
Lead Sponsor | Collaborator |
---|---|
Fujian Medical University Union Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | iDFS | 3-year invasive disease-free survival (iDFS) rate | 3 years |
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