Actively Recruiting
Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer
Led by Fudan University · Updated on 2024-03-22
1008
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
For patients with HER2-positive early-stage breast cancer, NCCN guidelines recommend chemotherapy plus targeted therapy as the standard adjuvant treatment for patients with tumors larger than 1 cm or lymph node-positive. The APT study enrolled patients with stage I HER2-positive breast cancer and has confirmed the efficacy and safety of intravenous chemotherapy combined with targeted therapy, but only 2.2% of the patients enrolled in microinvasion are enrolled, and there is a lack of large sample size data to provide a treatment reference for these patients. In order to further explore the optimal strategy for adjuvant therapy in this type of patient, we designed a new clinical trial to evaluate the efficacy and safety of oral capecitabine plus pyrotinib as adjuvant therapy in previous retrospective studies.
CONDITIONS
Official Title
Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 70 years
- Early breast cancer with microinvasion (longest invasive tumor diameter no more than 1 mm) and negative lymph nodes
- HER2-positive status confirmed by immunohistochemistry or FISH
- Hormone receptor status defined as HR-negative if ER and PR <1%; HR-positive if ER and/or PR 251%
- Patients with both invasive lesions eligible if both are HER2-positive
- ECOG performance status of 0 or 1
- No significant major organ dysfunction
- Blood counts within defined limits: ANC 251.5�d7109/L, platelets 100�d7109/L, hemoglobin 29 g/dl without recent transfusion
- Liver function tests within limits: total bilirubin 21.25 times ULN; AST and ALT <2.5 times ULN
- Kidney function adequate with creatinine clearance 250 mL/min and creatinine 2 1.5 times ULN
- Normal cardiac function: ECG normal, QTc <470 ms, LVEF >50%
- Contraception during treatment for women of childbearing potential
- No other cancer diagnosis within past 5 years
- Signed informed consent
- Ability to comply with follow-up and treatment requirements
You will not qualify if you...
- Invasive tumor size greater than 1 mm or positive axillary lymph nodes
- HER2-negative status by immunohistochemistry or lack of amplification by FISH
- Prior neoadjuvant or systemic therapy, including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy
- History of other malignant tumors except cured basal cell carcinoma or cervical carcinoma in situ
- Any metastasis
- Pregnant or breastfeeding women or women unable to use effective contraception
- Current participation in other clinical trials
- Severe organ dysfunction or cardiac conditions including LVEF <50%, severe cardiovascular diseases, poorly controlled diabetes or hypertension
- Severe or uncontrolled infections
- History of substance abuse or mental disorders
- Any condition deemed unsuitable by the investigator for study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Z
Zhimin Shao, MD
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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