Combining Pyrotinib and Capecitabine for Early HER2 Positive Breast Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of oral capecitabine combined with pyrotinib as adjuvant therapy for women with HER2-positive micro-invasive breast cancer. The study targets patients with early-stage breast cancer who have tumors that are 1mm or smaller and lymph node-negative. By focusing on this specific patient population, the trial aims to provide valuable data that is currently lacking in the treatment of micro-invasive breast cancer. The approach is based on previous studies that have shown promise in combining chemotherapy with targeted therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Breast cancer institute of Fudan University Cancer Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Zhimin Shao, MD
• Email: zhimingshao@yahoo.com
• Phone: +86-021-64175590

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Neoadjuvant Pyrotinib-to-pertuzumab for HER2-positive early breast cancer

  This trial tests whether a two-step neoadjuvant plan with Pyrotinib plus Trastuzumab and Docetaxel followed by Pertuzumab plus Trastuzumab and Docetaxel works better than four cycles of Pertuzumab plus Trastuzumab and Docetaxel in women with HER2-positive early- to locally advanced breast cancer.

  Recruiting Phase 3 Shanghai Jiao Tong University School of Medicine · Shanghai · NCT07797218

• Entinostat with Pyrotinib and Endocrine Therapy in HER2-positive, HR-positive Advanced Breast Cancer after Trastuzumab Failure

  This study tests whether adding entinostat to pyrotinib and hormone therapy is safe and helps patients with advanced HR+/HER2+ breast cancer who progressed after trastuzumab.

  Recruiting Phase 1/2 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07708194

• Pyrotinib plus trastuzumab and chemotherapy for HER2-positive early breast cancer

  This study tests a treatment combination of Pyrotinib, Trastuzumab and chemo given before surgery to see if it can improve responses in HER2-positive breast cancer patients who have not yet been treated.

  Recruiting Phase 2 Hebei Medical University Fourth Hospital · Shijiazhuang, Hebei · NCT07635342

• Capecitabine for MRD-positive, resected ER+/HER2-negative breast cancer

  This Phase 2 trial tests whether taking capecitabine can help people with resected, ER-positive/HER2-negative breast cancer who still have molecular residual disease after standard therapy.

  Recruiting Phase 2 University Health Network, Toronto · Toronto, Ontario · NCT07631052

• Pyrotinib and Trastuzumab with Dalpiciclib vs with Docetaxel in advanced HER2-positive breast cancer

  This study tests whether an oral regimen of pyrotinib + subcutaneous trastuzumab + dalpiciclib works as well as the standard IV regimen with docetaxel in people with advanced HER2-positive breast cancer who have limited prior treatment.

  Recruiting Phase 3 Fudan University · Shanghai, Shanghai Municipality · NCT07615751

• Pyrotinib-based regimens for advanced HER2-positive breast cancer: real-world sequential therapy after progression

  This real-world study tests whether giving disitamab vedotin after pyrotinib-based treatment helps people with advanced HER2-positive breast cancer.

  Recruiting Phase 4 Peking University People's Hospital · Beijing, Beijing Municipality · NCT07600164

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.