A Study on the Efficacy and Safety of Switching Between Two Targeted Strategies, HP+Chemotherapy and HPy+Chemotherapy, After Treatment Progression in HER-2 Positive Advanced or Metastatic Breast Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This study adopts a multicenter, natural selection, observational design, and plans to enroll patients with HER-2 positive advanced or metastatic breast cancer treated at approximately 20 research centers nationwide. Patients with de novo stage IV disease or those with recurrent metastatic breast cancer who have not previously received trastuzumab, as well as patients with brain metastases, will be included for separate stratified efficacy analysis and will not be included in the overall analysis. The study plans to enroll effective data from 600 HER-2 positive advanced or metastatic breast cancer patients, who will be naturally allocated in a 1:1 ratio to either Group A (switching from HP + chemotherapy to HPy + chemotherapy) or Group B (switching from HPy + chemotherapy to HP + chemotherapy), with each group comprising approximately 300 patients. If first-line treatment fails, patients will switch to the alternative regimen in second-line treatment. All patients will continue treatment until disease progression, intolerable toxicity, or other reasons lead to discontinuation, with the number of treatment cycles recorded. The study is divided into three phases: screening/baseline period, treatment period (treatment period 1 + treatment period 2), and survival follow-up period. If patients develop intolerance to taxanes during treatment, clinicians may select alternative chemotherapy regimens such as vinorelbine, capecitabine, or eribulin based on clinical judgment. During the treatment period, patients will be followed up every two cycles, during which clinical data will be collected, including disease status assessments, laboratory tests, study drug usage, concomitant medications, and adverse events. After chemotherapy completion or treatment discontinuation, subsequent maintenance therapy, such as continued dual-targeted maintenance, may be administered by clinicians based on clinical needs until disease progression or intolerable toxicity occurs. Survival follow-up will be conducted every three months (for up to three years), with patient survival status recorded.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Dobrowolnie podpisała zgodę na uczestnictwo w badaniu.
- •Kobieta w wieku 18 lat lub starszy.
- •Potwierdzony histologicznie rak piersi zaawansowany lub przerzutowy dodatni na HER2.
- •Przerzuty potwierdzone obrazowaniem (MRI lub tomografia), z co najmniej jednym zmienioną, którą można zmierzyć.
- •Jeśli wcześniej stosowano leczenie trastuzumabem lub inhibitorami kinazy tyrozynowej, nawrót choroby musi nastąpić ponad rok po zakończeniu poprzedniego leczenia.
- •Ogólny stan zdrowia oceniony na 0-2 w skali ECOG.
- •Spełnienie kryteriów leczenia określonych w protokole badania, w tym poprzednie leczenia linii pierwszej i drugiej zgodne z wymogami.
✗ Disqualifies
- •Znana uczulenie na leki stosowane w badaniu lub ich składniki.
- •Stosowanie leków, które mogą wpływać na działanie pirotinibu lub trastuzumabi (inhibitory lub induktory enzymu CYP3A4).
- •Ciąża lub karmienie piersią.
- •Poważna operacja w ciągu 4 tygodni przed rozpoczęciem badania bez pełnego wyleczenia.
- •Poważne choroby ogólne lub niekontrolowane infekcje.
- •Warunki zdrowotne mogące stanowić poważne zagrożenie dla bezpieczeństwa pacjenta (np. ciężka nadciśnienie, cukrzyca, zapalenie wątroby typu B lub C).
- •Historia innych nowotworów złośliwych.
- •Choroby psychiatryczne, problemy poznawcze lub niezdolność do współpracy w badaniu.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- March 6, 2026
- Sex
- Female only
Therapies / drugs in trial
Locations (1)
Zhejiang Cancer Hospital
Zhejiang, China
Trial contact
Ziwen Zhang
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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