NCT04001634

Brief Summary

To explore the real world situation of trastuzumab and lapatinib combined chemotherapy in China, and to explore the relationship between progression free survival and treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 27, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2020

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

4.4 years

First QC Date

June 27, 2019

Last Update Submit

February 23, 2024

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

  • PFS

    Progression free survival

    6 weeks

  • OS

    Overall survival

    6 weeks

  • ORR

    Objective Response Rate

    6 weeks

Secondary Outcomes (1)

  • Treatment Pattern

    6 weeks

Study Arms (1)

Dual anti-HER2 group

Dual anti-HER2 therapy (lapatinib and trastuzumab) plus chemotherapy

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage

You may qualify if:

  • \. woman, age \> 18 years old 2. Diagnosed with HER2 +Metastatic Breast Cancer 3. Dual anti-HER2 therapy (lapatinib and trastuzumab) plus chemotherapy for at least one cycle, starting from 2013.09.01-2019.07.31 4. Available medical history

You may not qualify if:

  • \. Incomplete medical history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biyun Wang, MD

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

  • Li Y, Gong C, Lu Q, Zhou Z, Luo T, Li W, Li G, Ge R, Xu F, Wang B. Real-World Data of Triplet Combination of Trastuzumab, Lapatinib, and Chemotherapy in HER2-Positive Metastatic Breast Cancer: A Multicenter Retrospective Study. Front Oncol. 2020 Mar 3;10:271. doi: 10.3389/fonc.2020.00271. eCollection 2020.

    PMID: 32195186DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Biyun Wang, Professor

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 27, 2019

First Posted

June 28, 2019

Study Start

January 1, 2015

Primary Completion

May 15, 2019

Study Completion

August 15, 2020

Last Updated

February 26, 2024

Record last verified: 2024-02

Locations

CN(1)