Early Breast CancerNCT07540520
A Real-World Study on the Impact of Different Adjuvant Treatment Regimens on Prognosis in Non-pCR Patients With HER2-Positive Breast Cancer After Neoadjuvant Therapy
An observational study of Early Breast Cancer, run by Hebei Medical University Fourth Hospital.
Trial summary
This study is a multicenter, retrospective, real-world cohort study. It retrospectively collected data from HER2-positive breast cancer patients who received neoadjuvant therapy with trastuzumab-containing chemotherapy regimens and had Non-pCR after surgery between July 2019 and July 2025. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early Breast Cancer
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 2 Aug 2026to 31 Dec 2026
- Phase
- Observational
- 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
Study population: The planned total number of cases is 2000.
Who may be able to join
- Histopathologically confirmed HER2-positive breast cancer (i.e., immunohistochemistry (IHC) staining result of 3+, or HER-2 2+ with fluorescence in situ hybridization showing HER-2 gene amplification);
- Received neoadjuvant therapy with chemotherapy combined with trastuzumab before surgery: including at least 6 cycles of chemotherapy, with at least 4 cycles of taxane-based chemotherapy; and at least 4 cycles of trastuzumab treatment (including trastuzumab biosimilars and subcutaneous formulations);
- Completion of radical surgery, postoperative pathology confirms the presence of invasive carcinoma in the breast and/or axillary lymph nodes after neoadjuvant therapy.
- Hormone receptor status is known.
Who cannot join
- Combine other systemic malignant tumors, excluding cured basal cell carcinoma of the skin and cervical carcinoma in situ;
- Stage IV metastatic breast cancer;
- Incomplete clinical pathology and follow-up data; Study endpoints
About this study
Official title: Retrospective Real-World Cohort Study on the Impact of Different Adjuvant Treatment Regimens on Prognosis in Non-pCR Patients With HER2-Positive Breast Cancer After Neoadjuvant Therapy
This study is a multicenter, retrospective, real-world cohort study. It retrospectively collected data from HER2-positive breast cancer patients who received neoadjuvant therapy with trastuzumab-containing chemotherapy regimens and had Non-pCR after surgery between July 2019 and July 2025. Patients were divided into two groups based on their adjuvant treatment regimens: the trastuzumab combined with pertuzumab group (HP) and the ado-trastuzumab emtansine group (T-DM1). The planned sample size is 2000 cases.
- Conditions
- Early Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HP | The trastuzumab combined with pertuzumab group | |
| T-DM1 | The ado-trastuzumab emtansine group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three-year invasive disease-free survival (iDFS) rate for non-pCR patients
iDFS events include local and regional recurrence, distant metastasis, contralateral invasive breast cancer, second non-breast primary cancer (excluding non-invasive carcinoma in situ), and death from any cause at 3 years.
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Secondary outcomes (3)
3-year iDFS rate in Near-pCR patients:
3-year iDFS rate in Near-pCR patients: iDFS events include local and regional recurrence, distant metastasis, contralateral invasive breast cancer, second non-breast primary cancer (excluding non-invasive carcinoma in situ), and death from any cause at 3 years in Near-pCR patients (Near-pCR is defined as Miller \& Payne grade 4, MP5 with invasive cancer present in axillary lymph nodes, RCB1).
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Overall survival
Overall Survival (OS) refers to the length of time from either the date of diagnosis or the start of treatment for a disease (such as cancer) until death from any cause.
Measured: It is a direct measure of the treatment's ultimate impact on patient survival.
Adverse Events
Safety refers to the assessment of adverse events (AEs) and potential risks associated with a medical intervention (e.g., drug, device, procedure)
Measured: From date of enrollment until adjuvant therapy after surgery 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start2 Aug 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Breast CancerStudies of the same condition, open and under way.
- More trials run by Hebei Medical University Fourth HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao Zhou, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540520
- Sponsor's protocol ID
- RWS
- Status last verified
- Apr 2026
- First submitted
- 19 Jan 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Real-World Cohort Study on the Impact of Different Adjuvant Treatment Regimens on Prognosis in Non-pCR Patients With HER2-Positive Breast Cancer After Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT07540520
- Acronym / sponsor ID
- RWS
- Conditions
- Early Breast Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 2 Aug 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Apr 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 is a multicenter, retrospective, real-world cohort study. It retrospectively collected data from HER2-positive breast cancer patients who received neoadjuvant therapy with trastuzumab-containing chemotherapy regimens and had Non-pCR after surgery between July 2019 and July 2025. Patients were divided into two groups based on their adjuvant treatment regimens: the trastuzumab combined with pertuzumab group (HP) and the ado-trastuzumab emtansine group (T-DM1). The planned sample size is 2000 cases.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HP | – | –The trastuzumab combined with pertuzumab group |
| T-DM1 | – | –The ado-trastuzumab emtansine group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The planned total number of cases is 2000.
Key inclusion criteria (4 listed)
- Histopathologically confirmed HER2-positive breast cancer (i.e., immunohistochemistry (IHC) staining result of 3+, or HER-2 2+ with fluorescence in situ hybridization showing HER-2 gene amplification);
- Received neoadjuvant therapy with chemotherapy combined with trastuzumab before surgery: including at least 6 cycles of chemotherapy, with at least 4 cycles of taxane-based chemotherapy; and at least 4 cycles of trastuzumab treatment (including trastuzumab biosimilars and subcutaneous formulations);
- Completion of radical surgery, postoperative pathology confirms the presence of invasive carcinoma in the breast and/or axillary lymph nodes after neoadjuvant therapy.
- Hormone receptor status is known.
Key exclusion criteria (3 listed)
- Combine other systemic malignant tumors, excluding cured basal cell carcinoma of the skin and cervical carcinoma in situ;
- Stage IV metastatic breast cancer;
- Incomplete clinical pathology and follow-up data; Study endpoints
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Three-year invasive disease-free survival (iDFS) rate for non-pCR patients
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
iDFS events include local and regional recurrence, distant metastasis, contralateral invasive breast cancer, second non-breast primary cancer (excluding non-invasive carcinoma in situ), and death from any cause at 3 years.
3 secondary outcomes
3-year iDFS rate in Near-pCR patients:
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Overall survival
Time frame: It is a direct measure of the treatment's ultimate impact on patient survival.
Adverse Events
Time frame: From date of enrollment until adjuvant therapy after surgery 1 year
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 20 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Breast Cancer, run by Hebei Medical University Fourth Hospital.
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 4 inclusion and 3 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 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Three-year invasive disease-free survival (iDFS) rate for non-pCR patients (time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.). 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 20 Apr 2026.