Could a Triple-Drug attack before surgery eliminate more breast cancer in older women?
NCT ID NCT07695259
First seen Jul 10, 2026 · Last updated Jul 10, 2026
Summary
This study tests whether adding the drug olaparib to standard trastuzumab and pertuzumab before surgery can improve outcomes for women aged 60 and older with HER2-positive breast cancer. Participants receive the combination for up to six cycles before surgery, and doctors check how much the tumor shrinks. The goal is to see if this approach leads to a higher rate of complete cancer clearance in the breast at the time of surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- olaparib combined with trastuzumab and pertuzumab
- What this could lead to
- If successful, this combination could offer a more effective pre-surgery treatment option for elderly patients with HER2-positive breast cancer, potentially increasing the chance of a complete response.
- What could go wrong
- This is a small, single-center Phase 4 study with only 45 participants, so results may not apply broadly. The drug combination may cause side effects like fatigue, nausea, or blood cell changes, and not all patients will respond.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Zhejiang Cancer Hospital
RECRUITINGHangzhou, Zhejiang, 310022, China
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Other studies related to the condition(s) this trial covers.
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- Can a Triple-Drug combo before surgery eliminate EGFR-Mutant lung cancer?
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- Can a Two-Drug punch shrink esophageal tumors before surgery?
- Can a Dual-Drug combo shrink lung tumors before surgery?
- Can a Two-Drug punch shrink oral tumors before surgery?