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NCT Number: NCT07695259

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

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.

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Key information

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location status: Recruiting

Location contact

Xiaowen Ding

CONTACT

[email protected]

8613588054604

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (1) Age ≥ 60 years old, female; (2) Patients with newly diagnosed unilateral primary invasive breast cancer confirmed by histopathological examination; (3) HER-2 positive (defined as immunohistochemical result of 3+ or immunohistochemical result of 2+ and in situ hybridization result positive); (4) Patients with TNM stage of II - IIIA (cT2N0M0, cT1N1M0, cT2N1M0, cT3N0M0, cT1N2M0, cT2N2M0, cT3N1M0, cT3N2M0); (5) According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, having at least one evaluable target lesion; (6) ECOG performance status score of 0 - 1; (7) Having adequate organ function, which meets the following criteria:
  • Blood routine examination: (within 7 days without using hematopoietic growth factors and blood transfusion)
  • White blood cells ≥ 3.0×109/L, neutrophils ≥ 1.5×109/L;
  • Platelets ≥ 100×109/L;
  • Hemoglobin ≥ 90g/L;

② Biochemical examination:

  • Total bilirubin ≤ 1.5×ULN;
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.0×ULN;
  • Serum creatinine ≤ 1.5×ULN or creatinine clearance rate ≥ 50 mL/min (calculated according to the Cockcroft-Gault formula);

③ Cardiac function examination:

  • Left ventricular ejection fraction (LVEF) ≥ 50%; (8) Voluntarily joining this study, signing informed consent, having good compliance and willing to cooperate with follow-up.

Exclusion criteria

  • (1) Concealed breast cancer, inflammatory breast cancer and eczematous carcinoma; (2) Patients known to be allergic to the active ingredients or other components of the study drug; (3) Those with severe heart diseases or discomfort, and expected to be unable to tolerate chemotherapy, including but not limited to: ① Fatal arrhythmia or higher-level atrioventricular block (second-degree type 2 atrioventricular block or third-degree atrioventricular block). ② Unstable angina pectoris. ③ Clinically significant valvular heart disease. ④ Echocardiogram showing transmural myocardial infarction; (4) Severe or uncontrolled infections that may affect the study treatment or the evaluation of study results, including but not limited to active hepatitis virus infection, positive human immunodeficiency virus (HIV) antibody, pulmonary infection, etc.; (5) History of other malignant tumors within the past 5 years (excluding cured cervical carcinoma in situ or skin basal cell carcinoma, etc.); (6) Participated in other clinical trials within 4 weeks before the study; (7) The investigator believes that the patient has any other conditions that are not suitable for participating in the study.

Treatment and study plan

olaparib combined with trastuzumab and pertuzumab

Drug

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

Primary outcomes

  1. Pathological complete remission rate in breast cancer

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaowen Ding

CONTACT

[email protected]

+8613588054604

Sponsors and collaborators

Lead sponsor

Wen-Ming Cao

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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