Actively 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
Led by Fujian Medical University Union Hospital · Updated on 2022-03-23
206
Participants Needed
1
Research Sites
339 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 65 18 years and 64 75 years old with primary breast cancer
- ECOG score 0 to 1
- Histologically or pathologically confirmed invasive breast cancer with primary tumor stage cT1-4/N0-3/M0
- Pathologically confirmed HER2-positive breast cancer defined by >10% immunoreactive cells with IHC score 3+ or HER2 gene amplification by ISH
- Known hormone receptor status (ER and PgR)
- Completed neoadjuvant therapy including at least 9 weeks of trastuzumab and 9 weeks of taxane chemotherapy
- Residual invasive breast cancer lesion > 2 cm or axillary lymph node positive with macrometastasis confirmed by pathology after neoadjuvant therapy
- No more than 12 weeks between end of surgery (without postoperative radiotherapy) and randomization or within 6 weeks after postoperative radiotherapy and randomization
- Required laboratory values: ANC 65 1.5 x 10^9/L, platelet count 65 90 x 10^9/L, hemoglobin 65 9.0 g/dL, total bilirubin 64 1.5 x ULN, ALT and AST 64 1.5 x ULN, BUN and creatinine clearance rate 65 50 mL/min
- Left ventricular ejection fraction 65 55%
- QTcF < 470 ms
You will not qualify if you...
- Stage IV (metastatic) breast cancer
- Inflammatory breast cancer
- Previous anti-tumor therapy or radiotherapy for any malignancy except cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma
- Receiving anti-tumor therapy in other clinical trials, including bisphosphonate therapy or immunotherapy (except radiotherapy and endocrine therapy during treatment)
- Receiving any anti-tumor therapy within 28 days before enrollment
- Peripheral neuropathy 65 Grade 2 as per NCI CTCAE
- Receiving pyrrolidone or other anti-HER2 tyrosine kinase inhibitors
- Receiving anthracycline therapy with cumulative doses above specified limits (adriamycin > 240 mg/m2, epirubicin > 480 mg/m2)
- Underwent major surgery unrelated to breast cancer before randomization or not fully recovered from such surgery
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
Research Team
C
Chuan Wang
CONTACT
S
Silu Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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