Breast CancerPhase 4NCT07589699
Trastuzumab Rezetecan (T-DXh) in HER2+ Breast Cancer With Non-pCR After TCbHP
A Phase 4 study testing Trastuzumab Rezetecan in people with Breast Cancer and HER2-positive Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
This is a prospective, multi-center, single-arm, phase 2 exploratory study to evaluate the efficacy and safety of adding 4 cycles of Trastuzumab Rezetecan (T-DXh), an anti-HER2 antibody-drug conjugate, as continued neoadjuvant therapy in patients with early or locally advanced HER2-positive breast cancer who have… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, HER2-positive Breast Cancer, Early-stage Breast Cancer
- What is being tested?
- Trastuzumab Rezetecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2026to 31 Dec 2031
- Phase
- Phase 4
- 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
- Age ≥ 18 years.
- For premenopausal and perimenopausal patients: negative pregnancy test and agreement to use reliable contraception during the treatment period.
- Pathologically confirmed HER2-positive invasive breast cancer (IHC 3+ or IHC 2+ with FISH+).
- Completed standard neoadjuvant TCbHP (taxane + carboplatin + trastuzumab + pertuzumab) with imaging assessment not achieving clinical complete remission (non-cCR).
- Agree to undergo a core needle biopsy.
- ECOG performance status 0 or 1.
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- Adequate organ function meeting the following criteria: hemoglobin ≥ 90 g/L, white blood cell count ≥ 3.5 × 10^9/L, platelet count ≥ 100 × 10^9/L, absolute neutrophil count ≥ 1.5 × 10^9/L, AST/ALT ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN, serum creatinine ≤ 1.5 × ULN.
- No myocardial ischemia on ECG; New York Heart Association (NYHA) functional class I; left ventricular ejection fraction (LVEF) ≥ 55% by echocardiography; cardiac troponin I (cTnI) and brain natriuretic peptide (BNP) within normal limits.
- Signed informed consent.
Who cannot join
- Male breast cancer or inflammatory breast cancer.
- Metastatic breast cancer (Stage IV).
- Concurrent other malignancy or history of other malignancy within the past 5 years, except adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
- Concurrent other anti-tumor therapy or participation in another clinical trial.
- Severe non-malignant disease that would affect compliance or place the patient at risk.
- Major surgery within 4 weeks prior to start of study treatment or anticipated need for major surgery during the study.
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- History of allergic reaction or contraindication to any component of the study drug.
- Dementia, mental abnormality, or any psychiatric illness that interferes with understanding of the informed consent.
- Any other condition assessed by the investigator as unsuitable for inclusion.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Arm, Exploratory Study of 4 Additional Cycles of Trastuzumab Rezetecan (T-DXh) as Neoadjuvant Therapy in Patients With Early or Locally Advanced HER2-Positive Breast Cancer Who Have Non-pCR After TCbHP Neoadjuvant Therapy
This is a prospective, multi-center, single-arm, phase 2 exploratory study to evaluate the efficacy and safety of adding 4 cycles of Trastuzumab Rezetecan (T-DXh), an anti-HER2 antibody-drug conjugate, as continued neoadjuvant therapy in patients with early or locally advanced HER2-positive breast cancer who have residual invasive disease after standard 6-cycle TCbHP (taxane, carboplatin, trastuzumab, pertuzumab) neoadjuvant therapy. Patients will receive 4 cycles of T-DXh (4.8 mg/kg IV Q3W) followed by radical surgery. The primary endpoint is tpCR rate. Secondary endpoints include ORR, EFS, OS, 3-year iDFS, and safety. Simon's two-stage design (H0: pCR ≤10%, H1: pCR ≥25%, α=0.05, β=0.2) requires 43 evaluable patients; with 10% dropout, 48 patients will be enrolled.
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, Early-stage Breast Cancer, Locally Advanced Breast Cancer
- Being tested
- Trastuzumab Rezetecan
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab RezetecanDrug
Also called T-DXh, SHR-A1811
An anti-HER2 antibody-drug conjugate (ADC) consisting of a humanized HER2-targeting monoclonal antibody (trastuzumab) conjugated to a DNA topoisomerase I inhibitor (SHR169265) via a cleavable tetrapeptide linker.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Trastuzumab Rezetecan (T-DXh) as Continued Neoadjuvant Therapy | Experimental | Patients with residual invasive disease after standard 6 cycles of TCbHP neoadjuvant therapy receive 4 cycles of Trastuzumab Rezetecan (T-DXh) 4.8 mg/kg intravenously every 3 weeks (Q3W), followed by radical surgery. After surgery:
* Patients achieving pathological complete response (pCR) receive 7 additional cycles of T-DXh as adjuvant therapy.
* Patients not achieving pCR receive investigator-selected adjuvant therapy (optional: trastuzumab + pertuzumab followed by 1 year of pyrotinib). Receives: Drug: Trastuzumab Rezetecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Pathological Complete Response (tpCR)
Absence of invasive residual cancer in both the breast primary tumor and axillary lymph nodes (ypT0/is, ypN0) after neoadjuvant therapy and surgery. Presence of ductal carcinoma in situ (DCIS) is allowed.
Measured: At the time of surgery, approximately 12 weeks after the start of the 4-cycle Trastuzumab Rezetecan treatment.
Secondary outcomes (4)
Event-Free Survival (EFS)
Time from first dose of study treatment to the earliest occurrence of any of the following: disease progression (per RECIST 1.1), local/regional/distant recurrence, second primary tumor (breast or other), or death from any cause.
Measured: From first dose up to 5 years after last patient enrolled.
Overall Survival (OS)
Time from first dose of study treatment to death from any cause.
Measured: From first dose up to 5 years after last patient enrolled.
3-Year Invasive Disease-Free Survival (iDFS) Rate
Percentage of patients who are free from invasive disease at 3 years after surgery. Invasive disease events include ipsilateral invasive breast tumor recurrence, local/regional invasive recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, or death from any cause.
Measured: 3 years after surgery.
Incidence of Adverse Events (AEs)
Number of participants experiencing adverse events. AEs are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0.
Measured: From signing of informed consent until 28 days after the last dose of study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start31 May 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Xiaoan, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589699
- Sponsor's protocol ID
- 26-OBU-JS-BC-II-017
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data (IPD) at this time. Only aggregated results will be reported in publications.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Exploratory Study of 4 Additional Cycles of Trastuzumab Rezetecan (T-DXh) as Neoadjuvant Therapy in Patients With Early or Locally Advanced HER2-Positive Breast Cancer Who Have Non-pCR After TCbHP Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT07589699
- Acronym / sponsor ID
- 26-OBU-JS-BC-II-017
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, Early-stage Breast Cancer, Locally Advanced Breast Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 31 May 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 15 May 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 is a prospective, multi-center, single-arm, phase 2 exploratory study to evaluate the efficacy and safety of adding 4 cycles of Trastuzumab Rezetecan (T-DXh), an anti-HER2 antibody-drug conjugate, as continued neoadjuvant therapy in patients with early or locally advanced HER2-positive breast cancer who have residual invasive disease after standard 6-cycle TCbHP (taxane, carboplatin, trastuzumab, pertuzumab) neoadjuvant therapy. Patients will receive 4 cycles of T-DXh (4.8 mg/kg IV Q3W) followed by radical surgery. The primary endpoint is tpCR rate. Secondary endpoints include ORR, EFS, OS, 3-year iDFS, and safety. Simon's two-stage design (H0: pCR ≤10%, H1: pCR ≥25%, α=0.05, β=0.2) requires 43 evaluable patients; with 10% dropout, 48 patients will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Trastuzumab Rezetecan (T-DXh) as Continued Neoadjuvant Therapy | Experimental | Drug: Trastuzumab RezetecanPatients with residual invasive disease after standard 6 cycles of TCbHP neoadjuvant therapy receive 4 cycles of Trastuzumab Rezetecan (T-DXh) 4.8 mg/kg intravenously every 3 weeks (Q3W), followed by radical surgery. After surgery: * Patients achieving pathological complete response (pCR) receive 7 additional cycles of T-DXh as adjuvant therapy. * Patients not achieving pCR receive investigator-selected adjuvant therapy (optional: trastuzumab + pertuzumab followed by 1 year of pyrotinib). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years.
- For premenopausal and perimenopausal patients: negative pregnancy test and agreement to use reliable contraception during the treatment period.
- Pathologically confirmed HER2-positive invasive breast cancer (IHC 3+ or IHC 2+ with FISH+).
- Completed standard neoadjuvant TCbHP (taxane + carboplatin + trastuzumab + pertuzumab) with imaging assessment not achieving clinical complete remission (non-cCR).
- Agree to undergo a core needle biopsy.
Key exclusion criteria (9 listed)
- Male breast cancer or inflammatory breast cancer.
- Metastatic breast cancer (Stage IV).
- Concurrent other malignancy or history of other malignancy within the past 5 years, except adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
- Concurrent other anti-tumor therapy or participation in another clinical trial.
- Severe non-malignant disease that would affect compliance or place the patient at risk.
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 |
|---|---|---|
| Trastuzumab RezetecanAlso: T-DXh, SHR-A1811An anti-HER2 antibody-drug conjugate (ADC) consisting of a humanized HER2-targeting monoclonal antibody (trastuzumab) conjugated to a DNA topoisomerase I inhibitor (SHR169265) via a cleavable tetrapeptide linker. | Drug | Experimental: Trastuzumab Rezetecan (T-DXh) as Continued Neoadjuvant Therapy |
Primary outcome
Total Pathological Complete Response (tpCR)
Time frame: At the time of surgery, approximately 12 weeks after the start of the 4-cycle Trastuzumab Rezetecan treatment.
Absence of invasive residual cancer in both the breast primary tumor and axillary lymph nodes (ypT0/is, ypN0) after neoadjuvant therapy and surgery. Presence of ductal carcinoma in situ (DCIS) is allowed.
4 secondary outcomes
Event-Free Survival (EFS)
Time frame: From first dose up to 5 years after last patient enrolled.
Overall Survival (OS)
Time frame: From first dose up to 5 years after last patient enrolled.
3-Year Invasive Disease-Free Survival (iDFS) Rate
Time frame: 3 years after surgery.
Incidence of Adverse Events (AEs)
Time frame: From signing of informed consent until 28 days after the last dose of study treatment.
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 15 May 2026.
- Individual participant dataSharing planned: No. No plan to share individual participant data (IPD) at this time. Only aggregated results will be reported in publications.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trastuzumab Rezetecan in people with Breast Cancer and HER2-positive Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University.
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 9 inclusion and 9 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 15 May 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Xiaoan Liu (86-25-83714511, liuxiaoan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Pathological Complete Response (tpCR) (time frame: At the time of surgery, approximately 12 weeks after the start of the 4-cycle Trastuzumab Rezetecan treatment.). 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 15 May 2026.