OncoMatch/Clinical Trials/NCT07695259
Olaparib+Trastuzumab+Pertuzumab Neoadjuvant for Elderly HER2+ Breast Cancer
Is NCT07695259 recruiting? Yes, currently enrolling (Jul 2026). This Phase 4 trial studies olaparib combined with trastuzumab and pertuzumab for elderly females.
Treatment: olaparib combined with trastuzumab and pertuzumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+ or IHC 2+ and ISH+)
HER-2 positive (defined as immunohistochemical result of 3+ or immunohistochemical result of 2+ and in situ hybridization result positive)
Disease stage
Required: Stage II, IIIA, CT2N0M0, CT1N1M0, CT2N1M0, CT3N0M0, CT1N2M0, CT2N2M0, CT3N1M0, CT3N2M0 (other)
TNM stage of II - IIIA (cT2N0M0, cT1N1M0, cT2N1M0, cT3N0M0, cT1N2M0, cT2N2M0, cT3N1M0, cT3N2M0)
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Lab requirements
Blood counts
White blood cells ≥ 3.0×10^9/L, neutrophils ≥ 1.5×10^9/L; platelets ≥ 100×10^9/L; hemoglobin ≥ 90g/L
Kidney function
Serum creatinine ≤ 1.5×ULN or creatinine clearance rate ≥ 50 mL/min (Cockcroft-Gault)
Liver function
Total bilirubin ≤ 1.5×ULN; AST and ALT ≤ 2.0×ULN
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50%
Having adequate organ function, which meets the following criteria: ... Blood routine examination: (within 7 days without using hematopoietic growth factors and blood transfusion) 1. White blood cells ≥ 3.0×10^9/L, neutrophils ≥ 1.5×10^9/L; 2. Platelets ≥ 100×10^9/L; 3. Hemoglobin ≥ 90g/L; Biochemical examination: 4. Total bilirubin ≤ 1.5×ULN; 5. AST and ALT ≤ 2.0×ULN; 6. Serum creatinine ≤ 1.5×ULN or creatinine clearance rate ≥ 50 mL/min (Cockcroft-Gault); Cardiac function examination: 7. LVEF ≥ 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07695259 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
What disease stage is eligible?
Stage II or IIIA or CT2N0M0 or CT1N1M0 or CT2N1M0 or CT3N0M0 or CT1N2M0 or CT2N2M0 or CT3N1M0 or CT3N2M0 is required.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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