NCT07589699Not yet recruitingPhase 4
Trastuzumab Rezetecan (T-DXh) in HER2+ Breast Cancer With Non-pCR After TCbHP
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
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 59 (estimated)
- First submitted
- 11 May 2026
- Start date
- 31 May 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07589699
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 59
- From 31 May 2026 to the primary completion date, 31 Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent other anti-tumor therapy or participation in another clinical trial.
- Major surgery within 4 weeks prior to start of study treatment or anticipated need for major surgery during the study.
- History of allergic reaction or contraindication to any component of the study drug.
Other illness
- 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.
- Severe non-malignant disease that would affect compliance or place the patient at risk.
- 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.
Who the study is looking for
- 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.
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.