NCT07829900Completed
First-Line Dual Versus Single HER2-Targeted Therapy With Docetaxel for Advanced HER2-Positive Breast Cancer
Real-world Comparative Effectiveness and Safety of Pertuzumab Plus Trastuzumab vs Trastuzumab as First-line Treatment for Advanced HER2-positive Breast Cancer: A Target Trial Emulation Study
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
This retrospective observational cohort study emulates a target trial to compare the effectiveness and safety of two first-line treatment strategies for women with HER2-positive unresectable locally advanced, recurrent, or metastatic breast cancer in routine clinical practice: pertuzumab plus trastuzumab and docetaxel versus trastuzumab and docetaxel. Data were obtained from electronic health records held by the National Health and Medical Big Data (Eastern) Center and linked with the Jiangsu Provincial Mortality Registry. Eligible patients initiated one of the two treatment strategies between January 1, 2020, and December 31, 2024. Time zero was defined as the date of the first administration of the qualifying first-line regimen. No minimum number of treatment cycles was required. The primary outcome was overall survival. Secondary outcomes included progression-free survival and prespecified adverse events.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 2250 (actual)
- First submitted
- 14 Sept 2026
- Start date
- 20 Apr 2020
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Xin Li
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07829900
What you commit to
- Study type: Observational
- Participants enrolled: 2250
- From 20 Apr 2020 to the primary completion date, 31 Dec 2024
- 1 site in 1 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
- Early-stage or resectable breast cancer treated with curative intent on the index date.
- Prior systemic anticancer therapy for unresectable locally advanced, recurrent, or metastatic breast cancer before the index date.
Other illness
- Another active primary malignant tumor on the index date that was expected to materially affect survival.
- Insufficient or invalid information to determine HER2 status, advanced disease status, index treatment regimen, or index date.
Other
- Absence of a valid patient identifier required for linkage between the electronic health record database and the mortality registry.
Who the study is looking for
- Female patients aged 18 years or older on the index date.
- Histologically or cytologically confirmed breast cancer.
- HER2-positive disease, defined according to available pathology records as immunohistochemistry (IHC) 3+ or IHC 2+ with positive in situ hybridization.
- Unresectable locally advanced, recurrent, or metastatic breast cancer on the index date.
- No prior systemic anticancer therapy for unresectable locally advanced, recurrent, or metastatic breast cancer before the index date.
- Initiation of first-line treatment with either:
- pertuzumab plus trastuzumab plus docetaxel; or
- trastuzumab plus docetaxel between January 1, 2020 and December 31, 2024.
- Sufficient information available on or before the index date to determine eligibility, treatment assignment, and baseline covariates.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.