Olaparib+Trastuzumab+Pertuzumab Neoadjuvant for Elderly HER2+ 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 is a single-center, interventional, prospective clinical study. A total of 45 patients aged ≥ 60 years with ECOG PS 0-1 who have histologically confirmed, treatment-naïve, unilateral primary invasive HER-2-positive breast cancer will be enrolled according to predefined inclusion/exclusion criteria. Participants will receive olaparib 300 mg orally twice daily combined with investigator-selected HP regimen (trastuzumab 8 mg/kg C1 → 6 mg/kg C2-6 and pertuzumab 840 mg C1 → 420 mg C2-6, both q3w) for up to six neoadjuvant cycles. Tumor response will be assessed after cycle 2; patients with inadequate response may switch to an alternative neoadjuvant regimen devised by the investigator for an additional 2-4 cycles before surgery, whereas responding patients will continue the original regimen to complete six cycles prior to surgery. Post-operatively, adjuvant therapy will be determined by pathological results: patients achieving pCR will complete one year of HP, while those with residual disease may receive escalated investigator-determined treatment. The primary endpoint is bpCR; secondary endpoints include 2-cycle ORR, tpCR, iDFS, incidence of adverse events, and quality-of-life assessments. Treatment will continue until disease progression or unacceptable toxicity. The study aims to evaluate the efficacy and safety of olaparib plus trastuzumab and pertuzumab as neoadjuvant therapy for elderly HER-2-positive breast cancer patients.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Kobieta w wieku 60 lat lub więcej
- •Nowo wykryty rak piersi jedno- lub dwustronny, potwierdzony badaniem histopatologicznym
- •Rak typu HER2-dodatni
- •Stan ogólny pacjentki: 0-1 wg skali ECOG (możliwość wykonywania zwykłych czynności)
- •Prawidłowa liczba białych krwinek, płytek krwi i hemoglobiny
- •Prawidłowa funkcja wątroby i nerek
- •Frakcja wyrzutowa lewej komory serca co najmniej 50%
- •Pisemna świadoma zgoda na udział w badaniu
✗ Disqualifies
- •Rak piersi ukryty, zapalny lub ekczemoidalny
- •Alergia na którykolwiek ze składników leków stosowanych w badaniu
- •Poważne choroby serca, zaburzenia rytmu serca lub niestabilna dławica piersiowa
- •Istotne zaburzenia zaworów serca
Simplified criteria — AI translation
Trial details
- Minimum age
- 60 Years
- Last updated (source)
- July 10, 2026
- Sex
- Female only
Therapies / drugs in trial
Locations (1)
Zhejiang Cancer Hospital
Hangzhou, China
Trial contact
Xiaowen Ding
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/11/2026.
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