{"type":"trials","record":{"id":43754,"source_id":"clinicaltrials-gov","external_id":"NCT07695259","title":"Olaparib+Trastuzumab+Pertuzumab Neoadjuvant for Elderly HER2+ Breast Cancer","brief_summary":"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.","overall_status":"Recruiting","phases":["PHASE4"],"study_type":"INTERVENTIONAL","sponsor":"Wen-Ming Cao","enrollment":45,"countries":["China"],"start_date":"2026-05-25","completion_date":"2027-12-31","last_update_date":"2026-07-10","source_url":"https://clinicaltrials.gov/study/NCT07695259","editorial_summary":"A registered PHASE4 study indexed because it matched monitored longevity research terms. Registry status: Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:25:40.376869+00:00","last_seen_at":"2026-09-25T03:15:05.717+00:00","metadata":{"acronym":null,"organization":"Zhejiang Cancer Hospital","source_has_results":false},"controlled_terms":["Elderly Females","HER2 + Breast Cancer","Neoadjuvant Therapy","olaparib combined with trastuzumab and pertuzumab"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: cancer.","quality_checked_at":"2026-09-25T03:15:14.669058+00:00","duplicate_cluster_key":"id:nct07695259","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-05-25 to 2027-12-31","comparator":null,"confidence":"structured-source","population":null,"provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T03:38:00.457301+00:00","intervention":[],"participants":45,"study_design":"INTERVENTIONAL","subject_scope":"Human clinical study registration","evidence_stage":"PHASE4","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":[],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"cancer-and-aging","is_published":true,"match_reasons":["Title contains controlled term: cancer.","Abstract contains controlled term: cancer, tumor.","Source terminology contains: cancer.","Title supplies longevity context: elderly.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Cancer and ageing","slug":"cancer-and-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/43754","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}