NCT02125630

Brief Summary

A registry trial evaluating resection of the primary breast tumor in women presenting with de novo stage IV breast cancer with bone metastasis only. Previous reports of carefully selected patients presenting with stage IV breast cancer suggest that surgery on the primary tumor may result in improved survival, but this remains unproven. The early results of our ongoing trial MF07-01 trial (a phase III randomized controlled trial of breast cancer women with distant metastases at presentation who receive loco-regional treatment for intact primary tumor compared with those who do not receive such treatment) showed that patients with bone metastasis only have a trend toward improved survival with initial surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
460

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

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, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2014

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

5.4 years

First QC Date

April 27, 2014

Last Update Submit

July 29, 2019

Conditions

Breast CancerSurgery

Keywords

Metastatic breast carcerBone metastasissurgery

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Years

    5 years

Secondary Outcomes (1)

  • Locoregional progression

    5 years

Study Arms (3)

Systemic therapy

Standart chemotherapy

Drug: Systemic therapy

Primary surgery

Standart surgery

Procedure: Surgery

Neoadjuvant chemotherapy

Standart chemotherapy followed by surgery

Procedure: SurgeryDrug: Systemic therapy

Interventions

SurgeryPROCEDURE

Surgery to primary tumor

Also known as: mastectomy, lumpectomy
Neoadjuvant chemotherapyPrimary surgery
Systemic therapyDRUG

Systemic therapy based on tumor phenotype

Also known as: Chemotherapy, hormone therapy, biphosphanetes
Neoadjuvant chemotherapySystemic therapy

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All female patients diagnosed with de novo stage IV breast cancer

You may qualify if:

  • Primary breast tumor amenable for complete surgical resection
  • Patients in good physical condition for receiving protocol driven locoregional and systemic treatment
  • Patients eligible for sentinel lymph node (SLN) biopsy and receiving radiotherapy.

You may not qualify if:

  • Primary tumor not amenable for complete resection (such as tumor extending to neighboring tissues; T4a,c or inflammatory breast cancer; T4d)
  • Primary tumor with extended infection, bleeding, or necrosis
  • Patients with poor physical condition which prevents the patient from receiving protocol driven locoregional and systemic treatment
  • Synchronous primary cancer at the contralateral breast
  • Previous diagnosis of other cancers (excluding basal cell skin cancer
  • Squamous cell skin cancer
  • Cervical intraepithelial neoplasia)
  • Clinically involved contralateral axillary nodes
  • Patients not suitable for adequate follow-up
  • Failure to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Medical faculty

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surgical Procedures, OperativeMastectomyMastectomy, SegmentalDrug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Atilla Soran, MD, MPH

    University of Pittsburgh

    STUDY CHAIR

  • Serdar Ozbas, MD

    Guven Hospital

    PRINCIPAL INVESTIGATOR

  • Lutfi Doğan, MD

    Ankara Onkoloji Hastanesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2014

First Posted

April 29, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

July 31, 2019

Record last verified: 2019-07

Locations

TU(1)