Actively Recruiting
A Randomized 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
Led by Fujian Medical University Union Hospital · Updated on 2022-03-23
206
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of continuing original targeted therapy compared with a combination of trastuzumab, pyrotinib, and capecitabine as postoperative adjuvant treatments for women with HER2-positive early breast cancer who still have residual tumor after neoadjuvant therapy. This phase 2 randomized study focuses on patients who did not achieve a complete response after initial treatment and aims to improve outcomes in this specific group. Participants in the experimental group will receive pyrotinib orally once daily at 400 mg, capecitabine orally twice daily at 1000 mg/m2 for 6 cycles, and trastuzumab with an initial loading dose followed by maintenance doses every 3 weeks for one year. The control group will continue their original neoadjuvant targeted therapy, which may include trastuzumab alone or combined with pertuzumab, with trastuzumab treatment lasting one year including both neoadjuvant and adjuvant phases. During the study, participants will be regularly monitored for invasive disease-free survival over a period of 3 years. Assessments will include clinical evaluations, laboratory tests, and imaging to track cancer progression and treatment effects. Safety and treatment adherence will be closely observed throughout the treatment and follow-up periods, which extend until the end of 2027.
CONDITIONS
Brief 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 18 to 75 years with primary breast cancer
- ECOG score between 0 and 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 IHC 3+ or HER2 gene amplification by ISH
- Known hormone receptor status (ER and PgR)
- Received at least 9 weeks of trastuzumab treatment and at least 9 weeks of taxane chemotherapy as neoadjuvant therapy
- Residual invasive breast cancer lesion larger than 2 cm or positive axillary lymph node with macrometastasis after neoadjuvant therapy
- Randomization within 12 weeks after end of surgery without postoperative radiotherapy or within 6 weeks after end of postoperative radiotherapy
- Required laboratory values: ANC ≥ 1.5 x 10^9/L, Platelets ≥ 90 x 10^9/L, Hemoglobin ≥ 9.0 g/dL, Total bilirubin ≤ 1.5 times upper limit of normal, ALT and AST ≤ 1.5 times upper limit of normal, BUN and creatinine clearance rate ≥ 50 mL/min, LVEF ≥ 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
- Received any anti-tumor therapy within 28 days before enrollment
- Peripheral neuropathy grade 2 or higher
- Receiving pyrrolidone or other anti-HER2 tyrosine kinase inhibitors
- Receiving anthracycline therapy with cumulative doses exceeding adriamycin > 240 mg/m2 or epirubicin > 480 mg/m2
- Major surgery unrelated to breast cancer before randomization or not fully recovered from such surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive targeted drug therapy with either trastuzumab combined with pyrotinib and capecitabine or continued trastuzumab-based therapy after surgery.
Visits every 3 weeks during treatment
Trial Site Locations
Total: 1 location
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
Research Team
C
Chuan Wang
S
Silu Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here