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Completed

NCT Number: NCT07829900

First-Line Dual Versus Single HER2-Targeted Therapy With Docetaxel for Advanced HER2-Positive Breast Cancer

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.

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Key information

Conditions

HER2-positive Breast Cancer Advanced Breast Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Nanjing Medical University

Nanjing, Jiangsu, 2111166, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Pertuzumab

Drug

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.

Trastuzumab

Drug

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.

docetaxel

Drug

Docetaxel administered as first-line chemotherapy in combination with HER2-targeted therapy. Exposure was identified from electronic prescriptions, medication orders, and administration records.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

    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.

  2. 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)

    Adverse-event severity was determined according to the severity grade documented in the electronic health record.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Xin Li

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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