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New study aims to decode HER2+ breast cancer for personalized treatment

NCT ID NCT07187752

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study will enroll over 1,000 women with HER2-positive breast cancer to analyze the molecular characteristics and subtypes of their tumors. Participants will receive standard pre-surgery treatment with trastuzumab, pertuzumab, and chemotherapy. The goal is to identify which subtypes respond best to this therapy, potentially paving the way for more personalized treatment approaches.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Trastuzumab and pertuzumab (biosimilars) plus chemotherapy
What this could lead to
If successful, this could help doctors better match HER2+ breast cancer treatments to individual patients based on their tumor's molecular profile.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly test a new therapy. Results may not lead to immediate changes in care.

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 1,039 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Jun 2027

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

18 to 75 years

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: 1. Age 18 - 75 years; 2. Eastern Cooperative Oncology Group (ECOG) score status 0-1. 3. Histologically confirmed invasive breast carcinoma with a primary tumor size of more than (\>) 2 centimeters (cm) by standard local assessment technique; Breast cancer stage at presentation: early-stage (T2-3, N0-1, M0) or locally advanced (T2-3, N2 or N3, M0; T4, any N, M0); 4. HER2-positive breast cancer confirmed by immunohistochemistry or HER2 gene amplification by in situ hybridization; 5. Known estrogen receptor (ER) and progesterone receptor (PgR) status. 6. Has adequate bone marrow, renal, hepatic and blood clotting functions. 7. Left ventricular ejection fraction (LVEF) ≥50 percent (%). 8. Women of childbearing potential and men with partners of childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and after the last dose for at least 7 months. Negative serum or urine pregnancy test within 7 days before study enrollment. 9. Willing to provide tissue for research purposes. 10. Volunteer to participate in this study and sign the informed consent. Exclusion Criteria: 1. Patients with stage IV metastatic breast cancer. 2. Bilateral invasive breast cancer; 3. Patients with breast cancer who have previously received anti-tumor therapy. 4. Occurred or present with other malignant tumors within 5 years. Patients with the following two conditions can be enrolled: other malignancies treated with a single operation, achieving continuous 5-year disease-free survival (DFS); Cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors \[Ta (non-invasive tumor), Tis (cancer in situ) and T1 (tumor infiltrating basal membrane)\]; 5. Subjects had participated in clinical trials of other antineoplastic drugs within 4 weeks before the group; 6. Has uncontrolled or significant cardiovascular disease. 7. Allergy to any investigational drug or any ingredient or excipient in the drug; 8. Female subjects who are pregnant, lactating or plan to become pregnant during the study. 9. Has any other condition that per protocol or in the opinion of the investigator is inappropriate for 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.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

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