Comparing the Efficacy of Nab-PH+Pyrrolitinib and TCbHP in the Neoadjuvant Treatment of HER2 Positive BC
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
At present, the incidence rate of breast cancer has exceeded that of lung cancer, becoming the largest cancer in the world. HER2 overexpression breast cancer accounts for about 20%\~30% of all breast cancer patients. HER2 is an important prognostic indicator and therapeutic target for breast cancer. Targeted therapy for HER2 protein is the core treatment of this type of breast cancer. Previous studies have confirmed that TKI drugs can reverse the resistance of large molecule monoclonal antibodies to a certain extent; Moreover, due to the complementarity of therapeutic targets, monoclonal antibodies are associated with TKI Drugs have synergistic effects. TCbHP is one of the preferred neoadjuvant chemotherapy schemes recommended by NCCN guidelines for HER2 positive breast cancer, but its incidence of adverse reactions such as vomiting, diarrhea, anemia, thrombocytopenia is significantly higher than that of the scheme without platinum. In the GeparOcto study and Geparsixto study, based on anthracycline+purple shirt+double target, the addition of carboplatin did not further improve the PCR rate of HER2 positive breast cancer neoadjuvant therapy. GeparSepto research showed that compared to the solvent based paclitaxel group, albumin paclitaxel increased the pCR rate by 8.2% and the IDFS by 7.3%. In the CA024 study, compared to docetaxel, albumin paclitaxel also significantly increased ORR and PFS. In the study by Lavasani SM et al., the neoadjuvant therapy of albumin paclitaxel combined with topiramate achieved a PCR rate of 64%. Therefore, we assume that the new adjuvant treatment scheme of Nab PH+pyrrolitinib can not be inferior to the efficacy of TCbHP, and has a lower incidence of adverse reactions, which may become a new adjuvant treatment option for HER2 positive breast cancer patients.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18-65 lat, dobry stan ogólny (ECOG 0-1)
- •Zaawansowany nowotwór piersi (T2-T4d lub T1c z przerzutami w węzłach chłonnych)
- •Rak piersi dodatni na HER2 potwierdzone badaniem histopatologicznym
- •Mierzalne zmiany widoczne w USG, mammografii lub MR w ciągu miesiąca przed losowaniem
- •Prawidłowe wyniki morfologii i biochemii: neutrocyty ≥2,0 × 10⁹/L, hemoglobina ≥90 g/L, płytki ≥100 × 10⁹/L, bilirubina <1,5 normy, kreatynina <1,5 normy, AST/ALT <1,5 normy
- •Prawidłowa funkcja serca: frakcja wyrzutowa lewej komory ≥55%
- •Kobiety w wieku rozrodczym z ujemnym testem ciąży 14 dni przed losowaniem
- •Podpisana świadoma zgoda na uczestnictwo w badaniu
✗ Disqualifies
- •Rak piersi w stadium IV (z przerzutami)
- •Poprzednia chemioterapia, hormonoterapia lub inne leczenie tego nowotworu
- •Inny nowotwór złośliwy (z wyjątkiem wyleczonego raka skóry)
- •Poważne zabiegi chirurgiczne niezwiązane z rakiem piersi w ciągu 4 tygodni przed włączeniem
- •Poważne choroby serca: niewydolność serca, arytmie, angina, wady zastawek, zawał mięśnia sercowego, niekontrolowane nadciśnienie
- •Inne poważne i niekontrolowane choroby stanowiące przeciwwskazanie do chemioterapii
- •Alergia na składniki leku, HIV dodatnie, immunodeficyt lub historia przeszczepienia narządu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Last updated (source)
- March 7, 2025
- Sex
- Female only
Therapies / drugs in trial
Locations (1)
Henan cancer hospital
Zhengzhou, China
Trial contact
Zhenzhen Liu
Dechuang Jiao
Contact information from ClinicalTrials.gov. Contact in English.
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Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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