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Olaparib+Trastuzumab+Pertuzumab Neoadjuvant for Elderly HER2+ Breast Cancer

NCT07695259 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-07-10

No results posted yet for this study

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.

Conditions

  • Elderly Females
  • HER2 + Breast Cancer
  • Neoadjuvant Therapy

Interventions

DRUG

olaparib combined with trastuzumab and pertuzumab

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

Sponsors & Collaborators

  • Wen-Ming Cao

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-25
Primary Completion
2027-12-01
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07695259 on ClinicalTrials.gov