Breast Cancer (Early Breast Cancer)Phase 2HER2levelNCT07844018
ADC Based Therapy Accroding to HER2 Heterogeneous
A Phase 2 study testing HER2 target therapy in people with Breast Cancer (Early Breast Cancer), run by Peking University People's Hospital at 1 site in China.
Trial summary
This study adopts a single-center, open-label, single-arm interventional design. It will enroll 88 patients with histologically confirmed HER2-positive early breast cancer who are suitable for surgery and neoadjuvant therapy, and stratify them by HER2 homogeneity/heterogeneity based on histological analysis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer (Early Breast Cancer)
- What is being tested?
- HER2 target therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2027to 30 Jun 2029
- Phase
- Phase 2
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.18 years or older and be treatment-naïve breast cancer patients 2.histology confirmed invasive breast carcinoma.HER2-positive defined by our pathology department, defined as IHC 3+ or IHC 2+ with fluorescence/chromogenic in situ hybridization (FISH/CISH) confirming HER2 gene amplification; 3.Clinically staged as Stage II or III according to AJCC 8th edition 4.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 5.Adequate function of major organs to meet study safety and tolerability requirements 6.Agree to provide tissue biopsies and/or blood samples at specified study timepoints (baseline, after cycle 4, after cycle 8, and at surgical resection) for translational research purposes 7.No contraindication to breast-enhanced MRI (no contraindications to breast MRI enhancement 8.Reproductive-age women must have a negative serum pregnancy test within 7 days prior to enrollment and agree to use an effective form of contraception recognized clinically during the study and for 3 months after the last study drug administration 9.agrees to participate in this study and signs the informed consent form
Who cannot join
- 1.bilateral breast cancer or presenting as recurrent or metastatic disease 2.Within the preceding 5 years prior to written informed consent, any history of malignant neoplasm other than treated cervical in situ carcinoma, skin basal cell carcinoma, or skin squamous cell carcinoma will exclude the subject 3.Within 4 weeks prior to enrollment, subjects who have undergone major surgery unrelated to breast cancer, or who have not fully recovered from such surgery, are excluded; procedures necessary for diagnostic tissue biopsy or peripheral venous catheter placement are allowed 4.History of interstitial lung disease (ILD) or non-infectious pneumonia, or current active ILD/pneumonia, or radiologic findings during screening that cannot exclude suspected ILD/pneumonia 5.Presence of significant cardiac disease or other conditions that would make participation unsafe or unsuitable 6.Severe infection within 4 weeks prior to the first dose 7.Known HIV infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis B (HBV-DNA ≥ 500 IU/mL) or hepatitis C (HCV-RNA above the assay's lower limit) or co-infection with HBV and HCV; autoimmune hepatitis 8.Known hypersensitivity to the study drug or any of its excipients 9.Pregnant or lactating women; women of childbearing potential with a positive baseline pregnancy test; or women unwilling to use an effective contraception method throughout the study 10.History of definite neurologic or psychiatric disorders including epilepsy or dementia, or known history of psychiatric drug abuse, alcoholism, or substance misuse 11.Any other condition that, in the opinion of the investigator, would make participation unsuitable for this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
yuan peng, 86+13671287670, 13671287670@163.com
About this study
Official title: A Prospective, Single-Arm Study of Anti-HER2 Antibody-Drug Conjugates in HER2-Positive Homogeneous and Heterogeneous Early Breast Cancer as Neoadjuvant Therapy
This study adopts a single-center, open-label, single-arm interventional design. It will enroll 88 patients with histologically confirmed HER2-positive early breast cancer who are suitable for surgery and neoadjuvant therapy, and stratify them by HER2 homogeneity/heterogeneity based on histological analysis. Subjects are not randomized and all will enter the intervention arm; patients with different HER2 homogeneity/heterogeneity will receive regimens based on anti-HER2 antibody-drug conjugates (ADCs). Recruitment is planned to commence in January 2027 and complete enrollment by December 2028. After obtaining fully informed consent and meeting eligibility criteria, eligible subjects will enter the trial phase and receive a regimen based on anti-HER2 ADCs. Once enrolled, subjects must receive the investigational drug within 72 hours. Each treatment cycle lasts 3 weeks, for a total of 8 cycles, and treatment will continue until the end of the course or until disease progression, unacceptable toxicity, death, withdrawal of informed consent, loss to follow-up, study completion, or study termination.
- Conditions
- Breast Cancer (Early Breast Cancer)
- Being tested
- HER2 target therapy
- Keywords
- HER2 positive, ADCs, neoadjuvant therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HER2 target therapyDrug
Based on HER2 immunohistochemistry (IHC) results, HER2 homogeneity/heterogeneity will be defined. Patients with homogeneous HER2 expression will receive 8 cycles of T-DXd therapy, while patients with heterogeneous HER2 expression will receive sequential T-DXd followed by THP therapy.
| Study group | Role | What they receive |
|---|---|---|
| HER2-expression-based ADC therapy | Experimental | Based on HER2 immunohistochemistry (IHC) results, HER2 homogeneity/heterogeneity will be defined. Patients with homogeneous HER2 expression will receive 8 cycles of T-DXd therapy, while patients with heterogeneous HER2 expression will receive sequential T-DXd followed by THP therapy. Receives: Drug: HER2 target therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathology complete response rate
After completing neoadjuvant therapy, histopathological evaluation of hematoxylin and eosin (H\&E)-stained samples from the resected breast cancer tissue and all ipsilateral lymph node specimens shows no residual invasive carcinoma.
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (3)
bpCR
After completion of neoadjuvant therapy, histopathological evaluation of hematoxylin and eosin (H\&E)-stained resected breast cancer tissue shows no residual invasive carcinoma.
Measured: From enrollment to the end of treatment at 6 months
ORR
The proportion of subjects achieving complete response (CR) or partial response (PR) during neoadjuvant therapy as the best overall tumor response. Investigators will assess objective response rate (ORR) according to RECIST v1.1.
Measured: From enrollment to the end of treatment at 6 months
RCB
The Residual Cancer Burden (RCB) index and its corresponding RCB class (RCB 0-III) can be calculated from the primary tumor residual size (mm×mm), tumor cellularity (percentage), proportion of in situ carcinoma (percentage), the number of positive lymph nodes, and the greatest dimension of nodal metastasis (mm).
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start1 Jan 2027 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer (Early Breast Cancer)Studies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu Wang, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844018
- Sponsor's protocol ID
- 2026PHB659
- Acronym
- HER2level
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 2 Oct 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 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm Study of Anti-HER2 Antibody-Drug Conjugates in HER2-Positive Homogeneous and Heterogeneous Early Breast Cancer as Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT07844018
- Acronym / sponsor ID
- HER2level / 2026PHB659
- Conditions
- Breast Cancer (Early Breast Cancer)
- Keywords
- HER2 positive, ADCs, neoadjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 28 Sep 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.
This study adopts a single-center, open-label, single-arm interventional design. It will enroll 88 patients with histologically confirmed HER2-positive early breast cancer who are suitable for surgery and neoadjuvant therapy, and stratify them by HER2 homogeneity/heterogeneity based on histological analysis. Subjects are not randomized and all will enter the intervention arm; patients with different HER2 homogeneity/heterogeneity will receive regimens based on anti-HER2 antibody-drug conjugates (ADCs). Recruitment is planned to commence in January 2027 and complete enrollment by December 2028. After obtaining fully informed consent and meeting eligibility criteria, eligible subjects will enter the trial phase and receive a regimen based on anti-HER2 ADCs. Once enrolled, subjects must receive the investigational drug within 72 hours. Each treatment cycle lasts 3 weeks, for a total of 8 cycles, and treatment will continue until the end of the course or until disease progression, unacceptable toxicity, death, withdrawal of informed consent, loss to follow-up, study completion, or study termination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HER2-expression-based ADC therapy | Experimental | Drug: HER2 target therapyBased on HER2 immunohistochemistry (IHC) results, HER2 homogeneity/heterogeneity will be defined. Patients with homogeneous HER2 expression will receive 8 cycles of T-DXd therapy, while patients with heterogeneous HER2 expression will receive sequential T-DXd followed by THP therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.18 years or older and be treatment-naïve breast cancer patients 2.histology confirmed invasive breast carcinoma.HER2-positive defined by our pathology department, defined as IHC 3+ or IHC 2+ with fluorescence/chromogenic in situ hybridization (FISH/CISH) confirming HER2 gene amplification; 3.Clinically staged as Stage II or III according to AJCC 8th edition 4.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 5.Adequate function of major organs to meet study safety and tolerability requirements 6.Agree to provide tissue biopsies and/or blood samples at specified study timepoints (baseline, after cycle 4, after cycle 8, and at surgical resection) for translational research purposes 7.No contraindication to breast-enhanced MRI (no contraindications to breast MRI enhancement 8.Reproductive-age women must have a negative serum pregnancy test within 7 days prior to enrollment and agree to use an effective form of contraception recognized clinically during the study and for 3 months after the last study drug administration 9.agrees to participate in this study and signs the informed consent form
Key exclusion criteria (1 listed)
- 1.bilateral breast cancer or presenting as recurrent or metastatic disease 2.Within the preceding 5 years prior to written informed consent, any history of malignant neoplasm other than treated cervical in situ carcinoma, skin basal cell carcinoma, or skin squamous cell carcinoma will exclude the subject 3.Within 4 weeks prior to enrollment, subjects who have undergone major surgery unrelated to breast cancer, or who have not fully recovered from such surgery, are excluded; procedures necessary for diagnostic tissue biopsy or peripheral venous catheter placement are allowed 4.History of interstitial lung disease (ILD) or non-infectious pneumonia, or current active ILD/pneumonia, or radiologic findings during screening that cannot exclude suspected ILD/pneumonia 5.Presence of significant cardiac disease or other conditions that would make participation unsafe or unsuitable 6.Severe infection within 4 weeks prior to the first dose 7.Known HIV infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis B (HBV-DNA ≥ 500 IU/mL) or hepatitis C (HCV-RNA above the assay's lower limit) or co-infection with HBV and HCV; autoimmune hepatitis 8.Known hypersensitivity to the study drug or any of its excipients 9.Pregnant or lactating women; women of childbearing potential with a positive baseline pregnancy test; or women unwilling to use an effective contraception method throughout the study 10.History of definite neurologic or psychiatric disorders including epilepsy or dementia, or known history of psychiatric drug abuse, alcoholism, or substance misuse 11.Any other condition that, in the opinion of the investigator, would make participation unsuitable for this study.
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 |
|---|---|---|
| HER2 target therapyBased on HER2 immunohistochemistry (IHC) results, HER2 homogeneity/heterogeneity will be defined. Patients with homogeneous HER2 expression will receive 8 cycles of T-DXd therapy, while patients with heterogeneous HER2 expression will receive sequential T-DXd followed by THP therapy. | Drug | HER2-expression-based ADC therapy |
Primary outcome
pathology complete response rate
Time frame: From enrollment to the end of treatment at 6 months
After completing neoadjuvant therapy, histopathological evaluation of hematoxylin and eosin (H\&E)-stained samples from the resected breast cancer tissue and all ipsilateral lymph node specimens shows no residual invasive carcinoma.
3 secondary outcomes
bpCR
Time frame: From enrollment to the end of treatment at 6 months
ORR
Time frame: From enrollment to the end of treatment at 6 months
RCB
Time frame: From enrollment to the end of treatment at 6 months
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 2 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HER2 target therapy in people with Breast Cancer (Early Breast Cancer), run by Peking University People's Hospital at 1 site in China.
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 1 inclusion and 1 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 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact yuan peng (86+13671287670, 13671287670@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathology complete response rate (time frame: From enrollment to the end of treatment at 6 months). 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 2 Oct 2026.