Using pyrotinib and trastuzumab for maintenance therapy in 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 observational study evaluates the effectiveness of pyrotinib combined with trastuzumab as maintenance therapy following first-line taxoid chemotherapy and trastuzumab for patients with HER2-positive advanced breast cancer. Participants will have received at least four cycles of initial treatment and will be monitored for the incidence of brain metastases as a primary endpoint. The study aims to assess the impact of this combination therapy on delaying disease progression and managing brain metastases. It involves multiple centers and focuses on real-world outcomes in a clinical setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age: 18-70 years old, female;
2. Pathological examination confirmed HER-2 positive invasive breast cancer; Her2-positive is defined as \>10% of tumor cells with an immunohistochemical (IHC) score of 3+ or in situ hybridization (ISH) results as HER2 gene amplification. A positive HER2 should be confirmed by the pathology department of the participating center of this study.) Imaging examination confirmed recurrent/metastatic breast cancer;
3. Patients with recurrence or metastasis more than 1 year after trastuzumab treatment, or newly diagnosed stage IV breast cancer;
4. ECOG score is 0-1;
5. Expected survival ≥6 months;
6. Normal function of major organs;
7. 1\) Blood routine • ANC≥1.5×109/L; • PLT≥90×109/L; • Hb≥90 g/L; 2) Blood biochemistry • TBIL≤1.5×ULN; • ALT and AST≤2 x ULN; For patients with liver metastases, ALT and AST≤5× ULN; • BUN and Cr ≤ 1.5×ULN and creatinine removal rate ≥ 50 mL/min; 3) Heart color ultrasound • LVEF≥50%;
8. The researcher believes that the subject is likely to benefit;
9. Voluntarily participate in the study and sign the informed consent

Exclusion Criteria:

1. Head MRI or head CT confirms the presence of brain metastases;
2. Have multiple factors affecting oral medication (history of gastrointestinal surgery, inability to swallow, chronic diarrhea, intestinal obstruction);
3. Study patients allergic to drugs and excipients;
4. Suffering from mental illness or psychotropic substance abuse, unable to cooperate;
5. Pregnant or lactating women;
6. Participated in clinical trials within 4 weeks;
7. Participants considered unsuitable for inclusion by the researchers.

Where it's running

• Fujian Union Medical College Hospital
  Fuzhou, Fujian, China Recruiting

Similar studies

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

• 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

• 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

• GQ1005 versus T-DM1 in HER2-positive unresectable or metastatic breast cancer

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  Recruiting at 70 sites Phase 3 GeneQuantum Healthcare (Suzhou) Co., Ltd. · Bengbu, Anhui and 69 other locations · NCT07673029

• Trastuzumab Rezetecan Neoadjuvant Therapy for HER2-Positive Breast Cancer

  This trial tests whether adding trastuzumab rezetecan after an initial THP treatment helps patients with HER2-positive breast cancer decide if they should switch therapies based on response.

  Recruiting Phase 2 The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT07647263

• 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

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.