HER2-Positive Breast CancerNCT07829900
First-Line Dual Versus Single HER2-Targeted Therapy With Docetaxel for Advanced HER2-Positive Breast Cancer
An observational study of HER2-Positive Breast Cancer and Advanced Breast Cancer, run by Xin Li at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2-Positive Breast Cancer, Advanced Breast Cancer
- What is being tested?
- Pertuzumab, Trastuzumab and Docetaxel
- How many people
- 2,250 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 study population comprised adult female patients with HER2-positive unresectable locally advanced, recurrent, or metastatic breast cancer who initiated first-line treatment with either pertuzumab plus trastuzumab plus docetaxel or trastuzumab plus docetaxel between January 1, 2020 and December 31, 2024. Eligible patients were retrospectively identified from the National Health and Medical Big Data (Eastern) Center. Electronic health record data were linked to the Jiangsu mortality registry. The index date (time zero) was defined as the date of the first administration of the index treatment regimen. Patients meeting the prespecified eligibility criteria during the study period were included.
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
- 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.
- Absence of a valid patient identifier required for linkage between the electronic health record database and the mortality registry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
Patients were classified according to the first-line regimen initiated on the index date. Time zero was defined as the date of first administration of pertuzumab plus trastuzumab and chemotherapy or trastuzumab and chemotherapy. Eligibility criteria were assessed using information available on or before time zero. Patients were not required to complete a minimum number of treatment cycles and were followed from treatment initiation regardless of subsequent treatment discontinuation or modification.
- Being tested
- Pertuzumab, Trastuzumab, Docetaxel
- Keywords
- Pertuzumab, Trastuzumab, Docetaxel, Dual HER2-Targeted Therapy, Real-World Evidence, Target Trial Emulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PertuzumabDrug
Pertuzumab administered as part of first-line dual HER2-targeted therapy with trastuzumab and docetaxel. Exposure was identified from electronic prescriptions, medication orders, and administration records.
TrastuzumabDrug
Trastuzumab administered as part of first-line HER2-targeted therapy with docetaxel, with or without pertuzumab. Exposure was identified from electronic prescriptions, medication orders, and administration records.
DocetaxelDrug
Docetaxel administered as first-line chemotherapy in combination with HER2-targeted therapy. Exposure was identified from electronic prescriptions, medication orders, and administration records.
| Study group | Role | What they receive |
|---|---|---|
| Pertuzumab Plus Trastuzumab and Docetaxel | Not described Receives: Drug: Pertuzumab; Drug: Trastuzumab; Drug: Docetaxel | |
| Trastuzumab and Docetaxel | Not described Receives: Drug: Pertuzumab; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Overall survival was defined as the time from the first administration of the index first-line treatment regimen to death from any cause.
Measured: From the index date until death, last known follow-up, or December 31, 2024, whichever occurred first (up to 60 months)
Secondary outcomes (2)
Real-World Progression-Free Survival (rwPFS)
Real-world progression-free survival was defined as the time from the index date, defined as the first administration of the qualifying first-line treatment regimen, to the first documented real-world disease progression or death from any cause, whichever occurred first.
Measured: From the index date until documented real-world disease progression, death, last known progression-free follow-up, or December 31, 2024, whichever occurred first (up to 60 months)
Proportion of Participants With Prespecified Grade 3 or Higher Adverse Events
Adverse-event severity was determined according to the severity grade documented in the electronic health record.
Measured: From the index date through the documented end of first-line treatment (up to 60 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start20 Apr 2020
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-Positive Breast CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xin Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xin Li, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829900
- Sponsor's protocol ID
- NMU-HER2BC-RWE-001
- Status last verified
- Aug 2026
- First submitted
- 14 Sep 2026
- Last updated
- 21 Sep 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07829900
- Acronym / sponsor ID
- NMU-HER2BC-RWE-001
- Keywords
- Pertuzumab, Trastuzumab, Docetaxel, Dual HER2-Targeted Therapy, Real-World Evidence, Target Trial Emulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,250 participants (actual)
- Lead sponsor
- Xin LiUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 21 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 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.
Detailed description
Patients were classified according to the first-line regimen initiated on the index date. Time zero was defined as the date of first administration of pertuzumab plus trastuzumab and chemotherapy or trastuzumab and chemotherapy. Eligibility criteria were assessed using information available on or before time zero. Patients were not required to complete a minimum number of treatment cycles and were followed from treatment initiation regardless of subsequent treatment discontinuation or modification.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pertuzumab Plus Trastuzumab and Docetaxel | – | Drug: Pertuzumab, Drug: Trastuzumab, Drug: Docetaxel |
| Trastuzumab and Docetaxel | – | Drug: Pertuzumab, Drug: Docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprised adult female patients with HER2-positive unresectable locally advanced, recurrent, or metastatic breast cancer who initiated first-line treatment with either pertuzumab plus trastuzumab plus docetaxel or trastuzumab plus docetaxel between January 1, 2020 and December 31, 2024. Eligible patients were retrospectively identified from the National Health and Medical Big Data (Eastern) Center. Electronic health record data were linked to the Jiangsu mortality registry. The index date (time zero) was defined as the date of the first administration of the index treatment regimen. Patients meeting the prespecified eligibility criteria during the study period were included.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
- 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.
- Absence of a valid patient identifier required for linkage between the electronic health record database and the mortality registry.
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 |
|---|---|---|
| PertuzumabPertuzumab administered as part of first-line dual HER2-targeted therapy with trastuzumab and docetaxel. Exposure was identified from electronic prescriptions, medication orders, and administration records. | Drug | Pertuzumab Plus Trastuzumab and Docetaxel, Trastuzumab and Docetaxel |
| TrastuzumabTrastuzumab administered as part of first-line HER2-targeted therapy with docetaxel, with or without pertuzumab. Exposure was identified from electronic prescriptions, medication orders, and administration records. | Drug | Pertuzumab Plus Trastuzumab and Docetaxel |
| DocetaxelDocetaxel administered as first-line chemotherapy in combination with HER2-targeted therapy. Exposure was identified from electronic prescriptions, medication orders, and administration records. | Drug | Pertuzumab Plus Trastuzumab and Docetaxel, Trastuzumab and Docetaxel |
Primary outcome
Overall Survival (OS)
Time frame: From the index date until death, last known follow-up, or December 31, 2024, whichever occurred first (up to 60 months)
Overall survival was defined as the time from the first administration of the index first-line treatment regimen to death from any cause.
2 secondary outcomes
Real-World Progression-Free Survival (rwPFS)
Time frame: From the index date until documented real-world disease progression, death, last known progression-free follow-up, or December 31, 2024, whichever occurred first (up to 60 months)
Proportion of Participants With Prespecified Grade 3 or Higher Adverse Events
Time frame: From the index date through the documented end of first-line treatment (up to 60 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HER2-Positive Breast Cancer and Advanced Breast Cancer, run by Xin Li 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 9 inclusion and 5 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: finished, as of the sponsor's last update on 21 Sep 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall Survival (OS) (time frame: From the index date until death, last known follow-up, or December 31, 2024, whichever occurred first (up to 60 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 21 Sep 2026.