Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Location status: Recruiting
NCT Number: NCT07695259
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.
Interested in participating?
Request Info60 year and older
Female
Interventional
Phase 4
Hangzhou, Zhejiang, 310022, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
② Biochemical examination:
③ Cardiac function examination:
Exclusion criteria
Orelaparib (300 mg bid) combined with the investigator-selected HP regimen (trastuzumab 8 mg/kg C1→6 mg/kg C2-6, patuzumab 840 mg C1→420 mg C2-6, q3w) for neoadjuvant therapy for up to 6 cycles
Time frame: After 6 cycles of treatment with olaparib combined with trastuzumab and pertuzumab, the rate of complete pathological response of the breast was evaluated.
Contact information is provided by the study sponsor or research team.
Wen-Ming Cao
Other
A Study on the Efficacy and Safety of Olaparib Combined With Trasotuzumab and Pertuzumab in Neoadjuvant Treatment for Elderly Patients With HER-2 Positive Breast Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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