Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer

Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer (NCT05861271) is a Phase 2 interventional studying Breast Cancer Stage I, sponsored by Fudan University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Breast Cancer Stage I and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 1,008 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Women aged 18-70; 2. The pathology of early breast cancer after surgery is T1micN0: diagnosed by tissue sample (biopsy-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); 3. The pathological type of immunohistochemistry needs to meet the following conditions: HER-2 (3+) or HER-2 (0-2+) but amplified by FISH detection. 4. Hormone receptor negative (HR-) is defined as ER, PR expression is \<1%; Hormone receptor positivity (HR+) is defined as ER and/or PR expression ≥1%. 5. For patients with both invasive lesions, if both lesions are HER-2 positive, they can be enrolled. 6. ECOG score≦ 1 point; 7. No obvious dysfunction of major organs; 8. Blood routine: white blood cell count (ANC) at least 1.5×109/L, PLT≥100×109/L, blood Hb≥ 9 g/dl (no transfusion within 14 days); 9. Liver function: total bilirubin ≤1.25×ULN; AST and ALT \<2.5×ULN; 10. Renal function: kidney function (creatinine clearance) at least 50 mL/min, blood creatinine ≤ 1.5 ×ULN; 11. Cardiac function: ECG is generally normal, QTc\< 470 ms; LVEF \> 50%; 12. contraception during treatment for women of childbearing age; 13. No history of other malignant tumors in the past 5 years; 14. With the consent of the person and signed the willing to sign a consent form form, or signed by the patient's legal representative with the authorization of the patient. 15. Can be followed up and good compliance. Who Should NOT Join This Trial: 1. The maximum size of the infiltrate is more than 1mm in diameter or the axillary lymph node is positive 2. HER2 negative: immunohistochemical HER2-,+; Immunohistochemical HER2+ while FISH has no amplification; 3. 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Women aged 18-70; 2. The pathology of early breast cancer after surgery is 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); 3. The pathological type of immunohistochemistry needs to meet the following conditions: HER-2 (3+) or HER-2 (0-2+) but amplified by FISH detection. 4. Hormone receptor negative (HR-) is defined as ER, PR expression is \<1%; Hormone receptor positivity (HR+) is defined as ER and/or PR expression ≥1%. 5. For patients with both invasive lesions, if both lesions are HER-2 positive, they can be enrolled. 6. ECOG score≦ 1 point; 7. No obvious dysfunction of major organs; 8. Blood routine: ANC ≥1.5×109/L, PLT≥100×109/L, blood Hb≥ 9 g/dl (no transfusion within 14 days); 9. Liver function: total bilirubin ≤1.25×ULN; AST and ALT \<2.5×ULN; 10. Renal function: creatinine clearance ≥ 50 mL/min, blood creatinine ≤ 1.5 ×ULN; 11. Cardiac function: ECG is generally normal, QTc\< 470 ms; LVEF \> 50%; 12. contraception during treatment for women of childbearing age; 13. No history of other malignant tumors in the past 5 years; 14. With the consent of the person and signed the informed consent form, or signed by the patient's legal representative with the authorization of the patient. 15. Can be followed up and good compliance. Exclusion Criteria: 1. The maximum size of the infiltrate is more than 1mm in diameter or the axillary lymph node is positive 2. HER2 negative: immunohistochemical HER2-,+; Immunohistochemical HER2+ while FISH has no amplification; 3. 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 4. History of other malignant tumors, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; 5. Metastasis of any part; 6. Pregnant or lactating women, women of childbearing age who cannot be effectively contraceptives; 7. Patients who participate in other clinical trials at the same time; 8. Severe organ function (heart, lung, liver and kidney) insufficiency, LEVF \< 50% (ultracardiogram); severe cardiovascular and cerebrovascular diseases (such as: unstable angina, chronic heart failure, uncontrollable hypertension \>150/90mmgh, myocardial infarction or cerebrovascular accident) within 6 months before enrollment; diabetics with poor glycemic control; Patients with severe hypertension; 9. Severe or uncontrolled infection; 10. Those who have a history of psychotropic substance abuse and cannot quit or have a history of mental disorders; 11. Patients who are judged by the investigator to be unsuitable to participate in this study.

Treatments Being Tested

DRUG

Capecitabine，Pyrotinib

Pyrotinib and Capecitabine for half a year

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05861271), the sponsor (Fudan University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05861271 clinical trial studying?

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 opt… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05861271?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05861271?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05861271. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05861271. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.