Status:
RECRUITING
Compare 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
Lead Sponsor:
Fujian Medical University Union Hospital
Conditions:
Breast Cancer
Adjuvant Therapy
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
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 pat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT05292742
Start Date
July 2 2021
End Date
December 31 2027
Last Update
March 23 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001