New study aims to decode HER2+ breast cancer for personalized treatment
NCT ID NCT07187752
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
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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 1,039 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
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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18 to 75 years
- 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: 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.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
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