Promising combo aims to shrink tumors in elderly breast cancer patients
NCT ID NCT07589972
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of targeted drugs (trastuzumab and pertuzumab) plus a low-dose chemotherapy (vinorelbine) given before surgery to elderly patients (70+) with HER2-positive breast cancer. The goal is to see if this approach can completely eliminate cancer cells in the breast and lymph nodes. The trial will enroll 45 participants and monitor how well the tumors respond, with a focus on safety and effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- trastuzumab, pertuzumab, and vinorelbine
- What this could lead to
- If successful, this could offer a less toxic, effective pre-surgery treatment option for elderly patients with HER2-positive breast cancer, potentially improving outcomes without harsh side effects.
- What could go wrong
- This is a small, early-phase study with only 45 participants, so results may not apply broadly. The treatment may not work for everyone, and side effects from the chemotherapy and targeted drugs are possible.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
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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70 years and older
- Sex
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Anyone
- 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: * 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: 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. Exclusion Criteria: * 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. * History of uncontrolled psychoactive drug abuse or psychiatric disorders. Severe and/or uncontrolled underlying systemic diseases, including: 1. History of hypertensive crisis or hypertensive encephalopathy; uncontrolled hypertension (systolic blood pressure \>150 mmHg or diastolic blood pressure \>100 mmHg after antihypertensive treatment). 2. Confirmed heart failure or cardiac systolic dysfunction (LVEF \<55%). 3. 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). 4. 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.
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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 official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
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