Neoadjuvant Therapy in Elderly HER2-Positive Breast CancerNCT07589972
Neoadjuvant Trastuzumab, Pertuzumab Plus Metronomic Vinorelbine for Elderly HER2-Positive Breast Cancer
A study testing neoadjuvant therapy in people with Neoadjuvant Therapy in Elderly HER2-Positive Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
English Translation (Professional Medical Version) This study is a multicenter, prospective clinical trial designed to investigate the efficacy and safety of neoadjuvant therapy with trastuzumab plus pertuzumab combined with metronomic vinorelbine chemotherapy in elderly patients with HER2-positive breast cancer. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Neoadjuvant Therapy in Elderly HER2-Positive Breast Cancer
- What is being tested?
- neoadjuvant therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2026to 31 Dec 2028
- Phase
- Interventional
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subjects voluntarily participate in this study and sign informed consent.
- Age ≥70 years at the time of informed consent signing.
- ECOG performance status (PS) 0-1; expected survival >3 months.
- Primary HER2-positive breast cancer confirmed by histopathology or cytology.
- Primary tumor diameter >2 cm, or axillary lymph node metastasis.
- Laboratory indicators conform to the following standards:
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- Absolute neutrophil count (ANC) ≥1.5×10⁹/L; Absolute lymphocyte count (LC) ≥0.5×10⁹/L; Platelet count (PLT) ≥100×10⁹/L; Hemoglobin (Hb) ≥90 g/L; White blood cell count (WBC) 3.0×10⁹/L ≤ WBC ≤15×10⁹/L. Serum biochemistry (no blood transfusion or albumin infusion within 7 days before screening): ALT and AST ≤2.5×ULN; ALT and AST ≤5×ULN in patients with hepatic metastases. ALP ≤2.5×ULN (≤5×ULN for patients with bone tumor metastasis). BUN and Cr ≤1.5×ULN, and creatinine clearance ≥60 mL/min (Cockcroft-Gault formula).
- PT and APTT ≤1.5×ULN, INR ≤1.5×ULN (patients not receiving anticoagulation therapy).
- Urine protein <2+. If urine protein ≥2+, 24-hour urinary protein quantification ≤1 g.
- Thyroid-stimulating hormone (TSH) ≤ULN. Left ventricular ejection fraction (LVEF) ≥50%. Patients with abnormal TSH may be enrolled as long as T3 and T4 levels are normal.
Who cannot join
- Stage Ⅳ metastatic breast cancer, or patients who cannot undergo curative surgical resection after neoadjuvant therapy as assessed by investigators.
- Prior anti-tumor therapies including chemotherapy, endocrine therapy, anti-HER2 biological therapy, or previous breast surgery (excluding diagnostic biopsy for primary breast cancer).
- Other malignancies diagnosed within 3 years or concurrent malignant tumors at enrollment.
- The following cases are eligible: Other malignancies treated solely by surgery with continuous 5-year disease-free survival (DFS); cured cervical carcinoma in situ, non-melanoma skin cancer, superficial bladder tumors (Ta: non-invasive tumor, Tis: carcinoma in situ, T1: basement membrane-invasive tumor).
- Major surgery, incisional biopsy or severe traumatic injury within 28 days before study treatment (excluding diagnostic biopsy of primary breast cancer).
- Persistent unhealed wounds or fractures.
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- History of uncontrolled psychoactive drug abuse or psychiatric disorders.
- Severe and/or uncontrolled underlying systemic diseases, including:
- History of hypertensive crisis or hypertensive encephalopathy; uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg after antihypertensive treatment).
- Confirmed heart failure or cardiac systolic dysfunction (LVEF <55%).
- Grade ≥2 myocardial ischemia, myocardial infarction, arrhythmia (QTc ≥450 ms for males, QTc ≥470 ms for females), or grade ≥2 congestive heart failure (NYHA classification).
- Angina pectoris requiring anti-anginal medication.
- Comorbidities interfering with scheduled treatment, including severe pulmonary dysfunction, active pulmonary disease, or uncontrolled severe infection (≥Grade 2 per CTCAE 5.0).
- Allergy to any investigational drug, active ingredients or pharmaceutical excipients.
- Subjects with comorbidities that threaten safety or affect study completion, or those unsuitable for enrollment according to investigator judgment.
About this study
Official title: A Multicenter, Prospective Clinical Study of Neoadjuvant Therapy With Trastuzumab Plus Pertuzumab Combined With Metronomic Vinorelbine Chemotherapy in Elderly Patients With Early-Stage HER2-Positive Breast Cancer
English Translation (Professional Medical Version) This study is a multicenter, prospective clinical trial designed to investigate the efficacy and safety of neoadjuvant therapy with trastuzumab plus pertuzumab combined with metronomic vinorelbine chemotherapy in elderly patients with HER2-positive breast cancer.
Eligible patients were aged ≥70 years, with histopathologically confirmed primary HER2-positive breast cancer, and met the indications for neoadjuvant therapy as stipulated in the clinical guidelines for the diagnosis and treatment of breast cancer.
Read more
A Simon two-stage design was employed in this study, with a planned total enrollment of 45 patients. In the first stage, 14 patients would be enrolled. If the number of observed responders was no more than 6, the trial would be terminated; otherwise, the trial would advance to the second stage, and the total sample size would be expanded to 45 patients.
The treatment regimen comprised 6 cycles of trastuzumab combined with pertuzumab (subcutaneous pertuzumab/trastuzumab fixed-dose combination was permitted as an alternative to intravenous formulations) plus metronomic vinorelbine therapy. Tumor response was assessed by imaging every 2 cycles. Patients with a confirmed response would complete all 6 cycles of treatment and undergo surgery per investigator assessment; postoperative pathological reports would be evaluated to determine the achievement of tpCR. For non-responders, the treatment regimen would be modified or surgery would be performed at the investigator's discretion.
- Being tested
- neoadjuvant therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant therapyCombination product
Vinorelbine soft capsules 40 mg, orally (PO), three times weekly (tiw) Trastuzumab: initial loading dose 8 mg/kg, maintenance dose 6 mg/kg, intravenous infusion, administered once every 3 weeks.
Pertuzumab: initial loading dose 840 mg, maintenance dose 420 mg, intravenous infusion, administered once every 3 weeks.
Each treatment cycle lasts 3 weeks. Imaging evaluations, including breast MRI, ultrasonography and computed tomography (CT), were performed every 2 cycles. For patients with tumor response, surgical indication was assessed after 6 cycles of treatment. Postoperative pathology was used to determine the pathological complete response (pCR) rate, and adjuvant treatment regimens were formulated according to postoperative pathological findings.
| Study group | Role | What they receive |
|---|---|---|
| NHP | Experimental | Vinorelbine soft capsules 40 mg, orally (PO), three times weekly (tiw) Trastuzumab: initial loading dose 8 mg/kg, maintenance dose 6 mg/kg, intravenous infusion, administered once every 3 weeks.
Pertuzumab: initial loading dose 840 mg, maintenance dose 420 mg, intravenous infusion, administered once every 3 weeks.
Each treatment cycle lasts 3 weeks. Imaging evaluations, including breast MRI, ultrasonography and computed tomography (CT), were performed every 2 cycles. For patients with tumor response, surgical indication was assessed after 6 cycles of treatment. Postoperative pathology was used to determine the pathological complete response (pCR) rate, and adjuvant treatment regimens were formulated according to postoperative pathological findings. Receives: Combination Product: neoadjuvant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total pathological complete response (tpCR)
It indicates that no residual invasive cancer cells are detected pathologically in both primary breast lesions and axillary lymph nodes after neoadjuvant therapy and surgical operation.
Measured: through study completion, an average of 1 year
Secondary outcomes (8)
Event-free survival （EFS）
The time interval from study enrollment to the occurrence of any prognosis-impacting events, including local or distant recurrence, secondary primary malignancy, and all-cause death.
Measured: 5 years
Objective response rate in patients undergoing neoadjuvant therapy （ORR）
The proportion of patients who achieve remarkable tumor shrinkage meeting the criteria of partial response or complete response.
Measured: through study completion, an average of 1 year
Disease control rate（DCR）
The proportion of patients with clinically controlled tumors, including those with complete response, partial response and stable disease.
Measured: through study completion, an average of 1 year
Invasive disease-free survival （iDFS）
The time from surgery to invasive breast cancer recurrence, non-breast second primary tumor, or death from any cause.
Measured: 5 years
Relapse-free survival （RFS）
The time from surgery to any local or distant breast cancer recurrence, excluding non-breast second primary tumors and breast cancer-unrelated mortality.
Measured: 5 years
Distant metastasis-free survival （DMFS）
The time from treatment initiation to the development of distant metastasis.
Measured: 5 years
Overall survival （OS）
The time from subject enrollment to all-cause death.
Measured: 7 years
Safety evaluation （SE）
The proportion of patients with grade 3 or higher adverse events
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start20 Apr 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoadjuvant Therapy in Elderly HER2-Positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589972
- Sponsor's protocol ID
- NHP-ELDER-BC
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- 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 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Clinical Study of Neoadjuvant Therapy With Trastuzumab Plus Pertuzumab Combined With Metronomic Vinorelbine Chemotherapy in Elderly Patients With Early-Stage HER2-Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT07589972
- Acronym / sponsor ID
- NHP-ELDER-BC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 May 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.
English Translation (Professional Medical Version) This study is a multicenter, prospective clinical trial designed to investigate the efficacy and safety of neoadjuvant therapy with trastuzumab plus pertuzumab combined with metronomic vinorelbine chemotherapy in elderly patients with HER2-positive breast cancer.
Eligible patients were aged ≥70 years, with histopathologically confirmed primary HER2-positive breast cancer, and met the indications for neoadjuvant therapy as stipulated in the clinical guidelines for the diagnosis and treatment of breast cancer.
A Simon two-stage design was employed in this study, with a planned total enrollment of 45 patients. In the first stage, 14 patients would be enrolled. If the number of observed responders was no more than 6, the trial would be terminated; otherwise, the trial would advance to the second stage, and the total sample size would be expanded to 45 patients.
The treatment regimen comprised 6 cycles of trastuzumab combined with pertuzumab (subcutaneous pertuzumab/trastuzumab fixed-dose combination was permitted as an alternative to intravenous formulations) plus metronomic vinorelbine therapy. Tumor response was assessed by imaging every 2 cycles. Patients with a confirmed response would complete all 6 cycles of treatment and undergo surgery per investigator assessment; postoperative pathological reports would be evaluated to determine the achievement of tpCR. For non-responders, the treatment regimen would be modified or surgery would be performed at the investigator's discretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NHP | Experimental | Combination Product: neoadjuvant therapyVinorelbine soft capsules 40 mg, orally (PO), three times weekly (tiw) Trastuzumab: initial loading dose 8 mg/kg, maintenance dose 6 mg/kg, intravenous infusion, administered once every 3 weeks. Pertuzumab: initial loading dose 840 mg, maintenance dose 420 mg, intravenous infusion, administered once every 3 weeks. Each treatment cycle lasts 3 weeks. Imaging evaluations, including breast MRI, ultrasonography and computed tomography (CT), were performed every 2 cycles. For patients with tumor response, surgical indication was assessed after 6 cycles of treatment. Postoperative pathology was used to determine the pathological complete response (pCR) rate, and adjuvant treatment regimens were formulated according to postoperative pathological findings. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Subjects voluntarily participate in this study and sign informed consent.
- Age ≥70 years at the time of informed consent signing.
- ECOG performance status (PS) 0-1; expected survival >3 months.
- Primary HER2-positive breast cancer confirmed by histopathology or cytology.
- Primary tumor diameter >2 cm, or axillary lymph node metastasis.
Key exclusion criteria (15 listed)
- Stage Ⅳ metastatic breast cancer, or patients who cannot undergo curative surgical resection after neoadjuvant therapy as assessed by investigators.
- Prior anti-tumor therapies including chemotherapy, endocrine therapy, anti-HER2 biological therapy, or previous breast surgery (excluding diagnostic biopsy for primary breast cancer).
- Other malignancies diagnosed within 3 years or concurrent malignant tumors at enrollment.
- The following cases are eligible: Other malignancies treated solely by surgery with continuous 5-year disease-free survival (DFS); cured cervical carcinoma in situ, non-melanoma skin cancer, superficial bladder tumors (Ta: non-invasive tumor, Tis: carcinoma in situ, T1: basement membrane-invasive tumor).
- Major surgery, incisional biopsy or severe traumatic injury within 28 days before study treatment (excluding diagnostic biopsy of primary breast cancer).
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 |
|---|---|---|
| neoadjuvant therapyVinorelbine soft capsules 40 mg, orally (PO), three times weekly (tiw) Trastuzumab: initial loading dose 8 mg/kg, maintenance dose 6 mg/kg, intravenous infusion, administered once every 3 weeks. Pertuzumab: initial loading dose 840 mg, maintenance dose 420 mg, intravenous infusion, administered once every 3 weeks. Each treatment cycle lasts 3 weeks. Imaging evaluations, including breast MRI, ultrasonography and computed tomography (CT), were performed every 2 cycles. For patients with tumor response, surgical indication was assessed after 6 cycles of treatment. Postoperative pathology was used to determine the pathological complete response (pCR) rate, and adjuvant treatment regimens were formulated according to postoperative pathological findings. | Combination product | NHP |
Primary outcome
Total pathological complete response (tpCR)
Time frame: through study completion, an average of 1 year
It indicates that no residual invasive cancer cells are detected pathologically in both primary breast lesions and axillary lymph nodes after neoadjuvant therapy and surgical operation.
8 secondary outcomes
Event-free survival （EFS）
Time frame: 5 years
Objective response rate in patients undergoing neoadjuvant therapy （ORR）
Time frame: through study completion, an average of 1 year
Disease control rate（DCR）
Time frame: through study completion, an average of 1 year
Invasive disease-free survival （iDFS）
Time frame: 5 years
Relapse-free survival （RFS）
Time frame: 5 years
Distant metastasis-free survival （DMFS）
Time frame: 5 years
Overall survival （OS）
Time frame: 7 years
Safety evaluation （SE）
Time frame: through study completion, an average of 1 year
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 15 May 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing neoadjuvant therapy in people with Neoadjuvant Therapy in Elderly HER2-Positive Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital.
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 10 inclusion and 15 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: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total pathological complete response (tpCR) (time frame: through study completion, an average of 1 year). 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 15 May 2026.