Olaparib with Trastuzumab and Pertuzumab before surgery for older women with HER2-positive breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, interventional study enrolling 45 women aged 60 or older with ECOG 0-1 and untreated unilateral HER2-positive breast cancer. Participants receive olaparib 300 mg twice daily in combination with trastuzumab and pertuzumab for up to six neoadjuvant cycles, with tumor response assessed after cycle 2 and potential regimen adjustments before surgery. After surgery, adjuvant therapy is guided by pathological response, with those achieving a complete response potentially receiving one year of continued therapy. Eligibility requires confirmed HER2-positive, stage II–IIIA disease, measurable disease, adequate organ function, and good performance status.

Why it matters

Who can join: the full rules

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)

    1. White blood cells ≥ 3.0×109/L, neutrophils ≥ 1.5×109/L;
    2. Platelets ≥ 100×109/L;
    3. Hemoglobin ≥ 90g/L;

       ② Biochemical examination:
    4. Total bilirubin ≤ 1.5×ULN;
    5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.0×ULN;
    6. Serum creatinine ≤ 1.5×ULN or creatinine clearance rate ≥ 50 mL/min (calculated according to the Cockcroft-Gault formula);

       ③ Cardiac function examination:
    7. 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.

Where it's running

• Zhejiang Cancer Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Xiaowen Ding
• Email: dingxw@zjcc.org.cn
• Phone: +8613588054604

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.