BreCLIM-2 - A RCT Investigating Local Treatment for Breas... | NCT04079049

Studies
BreCLIM-2 - A RCT Investigating Local Treatment for Breast Cancer Liver Metastases

NCT04079049

Sponsor

Umeå University

Status

Recruiting

Last Update Posted

May 25, 2022Actual

Enrollment

200Estimated

Phase

Phase 3

Conditions

Breast Cancer
Liver Metastases

Interventions

Surgical intervention
Control

Countries

Sweden

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

May 2022

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Dec 31, 2029Estimated

Completion Date

Dec 31, 2029Estimated

First Submitted Date

Sep 2, 2019

First Submission Date that Met QC Criteria

Sep 2, 2019

First Posted Date

Sep 6, 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

May 24, 2022

Last Update Posted Date

May 25, 2022Actual

Name	Class
Uppsala University	OTHER
Karolinska Institutet	OTHER
Linkoeping University	OTHER_GOV
Lund University

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Breast cancer is the second most common cancer in Sweden with an incidence of 8000 per year. The role of surgery for distant breast cancer metastasis beyond local lymph nodes remains controversial even though some reports suggest there might be a survival benefit from resection of oligometastases in the liver.

The purpose of this multicentre randomized clinical trial is to evaluate local treatment for breast cancer liver metastases, compared to systemic oncological treatment only. The primary endpoint is time to death from any cause, which will be compared using cox proportional hazard regression. The secondary endpoints are three years survival, progression-free survival, median overall survival and quality of life. The aim is also to evaluate overall safety and predictive factors for survival during oncological and surgical treatment. The overall purpose is to ameliorate treatment for advanced breast cancer.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgical intervention	Experimental	Surgical and oncological treatment	Procedure: Surgical intervention
Control	Active Comparator	Oncological treatment	Drug: Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgical intervention	Procedure	Surgical intervention by liver resection, ablation or stereotactic body radiotherapy as complement to oncological treatment	Surgical intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival	Time to death from any cause	Three years after randomization

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent
>18 years old
ECOG 0-1
Breast cancer history
Breast cancer liver metastasis verified by biopsy
Patient amendable for liver surgery and pre- and postoperative oncological treatment
1-4 liver metastasis amendable to surgery with functional liver remnant volume >30%
Liver metastasis (and skeletal metastasis) stable or responding to preoperative oncological treatment

Exclusion Criteria:

Non-skeletal extrahepatic disease
Non-resected primary tumour
Pregnancy
Progression of disease upon oncological treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Oskar Hemmingsson, MD, PhD	Contact	0046707197548		oskar.hemmingsson@umu.se
Malin Sund, MD, PhD	Contact	0046907850000		malin.sund@umu.se

Overall Officials

Name	Affiliation	Role
Oskar Hemmingsson, MD, PhD	Umeå University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Umeå University Hospital	Recruiting	Umeå		90185	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided