Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Promising combo aims to shrink tumors in elderly breast cancer patients

NCT ID NCT07589972

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

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

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

70 years and older

Sex

Anyone

Healthy volunteers

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Early-stage HER2-positive breast cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. 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.

    Open the record ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.