Elderly FemalesPhase 4NCT07695259
Olaparib+Trastuzumab+Pertuzumab Neoadjuvant for Elderly HER2+ Breast Cancer
A Phase 4 study testing olaparib combined with trastuzumab and pertuzumab in people with Elderly Females and HER2 + Breast Cancer, run by Wen-Ming Cao at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Elderly Females, HER2 + Breast Cancer, Neoadjuvant Therapy
- What is being tested?
- olaparib combined with trastuzumab and pertuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2026to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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:
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- 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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Xiaowen Ding, 8613588054604, dingxw@zjcc.org.cn
About this study
Official 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
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
- Being tested
- olaparib combined with trastuzumab and pertuzumab
- Keywords
- HER2 positive breast cancer, neoadjuvant treastment, elderly breast cancer, PARP inhibitor
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olaparib combined with trastuzumab and pertuzumabDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Olaparib+Trastuzumab+Pertuzumab Receives: Drug: olaparib combined with trastuzumab and pertuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete remission rate in breast cancer
Measured: After 6 cycles of treatment with olaparib combined with trastuzumab and pertuzumab, the rate of complete pathological response of the breast was evaluated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start25 May 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly FemalesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wen-Ming Cao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wen-Ming Cao, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695259
- Sponsor's protocol ID
- IRB-2025-873（IIT）
- Status last verified
- Jul 2026
- First submitted
- 16 Sep 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07695259
- Acronym / sponsor ID
- IRB-2025-873（IIT）
- Conditions
- Elderly Females, HER2 + Breast Cancer, Neoadjuvant Therapy
- Keywords
- HER2 positive breast cancer, neoadjuvant treastment, elderly breast cancer, PARP inhibitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Wen-Ming CaoUniversity, hospital or other
- Study start
- 25 May 2026 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: olaparib combined with trastuzumab and pertuzumabOlaparib+Trastuzumab+Pertuzumab |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- (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:
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olaparib combined with trastuzumab and pertuzumabOrelaparib (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 | Drug | Treatment arm |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing olaparib combined with trastuzumab and pertuzumab in people with Elderly Females and HER2 + Breast Cancer, run by Wen-Ming Cao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaowen Ding (+8613588054604, dingxw@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.