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Two-Drug HER2 attack vs one: which First-Line strategy helps advanced breast cancer patients live longer?

NCT ID NCT07829900

NEW Disease control Sponsor: Xin Li Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are comparing two first-line treatment strategies for women with advanced HER2-positive breast cancer: pertuzumab plus trastuzumab and docetaxel, versus trastuzumab and docetaxel alone. The study uses real-world electronic health records from about 2,250 patients treated in routine practice. It measures overall survival, progression-free survival, and side effects to see which approach works better and is safer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pertuzumab plus trastuzumab with docetaxel, compared with trastuzumab and docetaxel
What this could lead to
If the dual therapy performs better, it could reinforce it as a standard first-line option for advanced HER2-positive breast cancer and help guide treatment choices in routine care.
What could go wrong
This is an observational study using existing medical records, so it cannot prove cause and effect and may miss details that a randomized trial would capture. Results may not apply to patients treated outside the studied health system.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

2,250 people

The number who actually took part.

Started

Apr 2020

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Female patients aged 18 years or older on the index date. 2. Histologically or cytologically confirmed breast cancer. 3. HER2-positive disease, defined according to available pathology records as immunohistochemistry (IHC) 3+ or IHC 2+ with positive in situ hybridization. 4. Unresectable locally advanced, recurrent, or metastatic breast cancer on the index date. 5. No prior systemic anticancer therapy for unresectable locally advanced, recurrent, or metastatic breast cancer before the index date. 6. Initiation of first-line treatment with either: 1. pertuzumab plus trastuzumab plus docetaxel; or 2. trastuzumab plus docetaxel between January 1, 2020 and December 31, 2024. 7. Sufficient information available on or before the index date to determine eligibility, treatment assignment, and baseline covariates. Exclusion Criteria: 1. Early-stage or resectable breast cancer treated with curative intent on the index date. 2. Prior systemic anticancer therapy for unresectable locally advanced, recurrent, or metastatic breast cancer before the index date. 3. Another active primary malignant tumor on the index date that was expected to materially affect survival. 4. Insufficient or invalid information to determine HER2 status, advanced disease status, index treatment regimen, or index date. 5. Absence of a valid patient identifier required for linkage between the electronic health record database and the mortality registry.

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Conditions

The condition(s) this trial relates to.

breast cancer HER2 positive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced breast cancer HER2-positive breast cancer

Contacts and locations

Locations

  • Nanjing Medical University

    Nanjing, Jiangsu, 2111166, China

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