Dual Anti-HER2 Therapy (Lapatinib and Trastuzumab) Plus C... | NCT04001634

Studies
Dual Anti-HER2 Therapy (Lapatinib and Trastuzumab) Plus Chemotherapy in HER2-positive MBC

NCT04001634

Sponsor

Fudan University

Status

Completed

Last Update Posted

Feb 26, 2024Actual

Enrollment

285Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2015Actual

Primary Completion Date

May 15, 2019Actual

Completion Date

Aug 15, 2020Actual

First Submitted Date

Jun 27, 2019

First Submission Date that Met QC Criteria

Jun 27, 2019

First Posted Date

Jun 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2024

Last Update Posted Date

Feb 26, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

285Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dual anti-HER2 group		Dual anti-HER2 therapy (lapatinib and trastuzumab) plus chemotherapy

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PFS	Progression free survival	6 weeks
OS	Overall survival	6 weeks
ORR	Objective Response Rate	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Treatment Pattern	Choice of Treatment	6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. 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

Exclusion Criteria:

1. Incomplete medical history

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Biyun Wang, Professor	Fudan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Biyun Wang, MD		Shanghai	Shanghai Municipality	200032	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32195186	Derived	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.

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases