OncoMatch/Clinical Trials/NCT05861271
Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer
Is NCT05861271 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Capecitabine，Pyrotinib for breast cancer stage i.
Treatment: Capecitabine，Pyrotinib — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+)
HER-2 (3+)
Required: HER2 (ERBB2) amplification
HER-2 (0-2+) but amplified by FISH detection
Disease stage
Required: Stage T1MICN0 (AJCC)
T1micN0: histologically confirmed that the longest diameter of invasive cancer does not exceed 1mm or the maximum diameter of multiple invasive lesions is less than 1mm, and the lymph node is negative (N0)
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: neoadjuvant therapy
Patients who have received neoadjuvant therapy or any other form of systemic therapy or local therapy other than surgery, including chemotherapy, targeted, radiotherapy, or endocrine therapy, prior to enrollment
Cannot have received: chemotherapy
Patients who have received ... chemotherapy ... prior to enrollment
Cannot have received: targeted therapy
Patients who have received ... targeted ... prior to enrollment
Cannot have received: radiation therapy
Patients who have received ... radiotherapy ... prior to enrollment
Cannot have received: endocrine therapy
Patients who have received ... endocrine therapy ... prior to enrollment
Lab requirements
Blood counts
anc ≥1.5×109/l, plt≥100×109/l, blood hb≥ 9 g/dl (no transfusion within 14 days)
Kidney function
creatinine clearance ≥ 50 ml/min, blood creatinine ≤ 1.5 ×uln
Liver function
total bilirubin ≤1.25×uln; ast and alt <2.5×uln
Cardiac function
ecg is generally normal, qtc< 470 ms; lvef > 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05861271 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 amplification is a required biomarker for enrollment.
What disease stage is eligible?
Stage T1MICN0 is required.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages