CClinicalTrials.gg
CompletedNCT02125630Updated Jul 31, 2019

Bone Metastasis and Surgery in Breast Cancer

An observational study in Breast Cancer and Surgery, sponsored by Federation of Breast Diseases Societies. Completed at 1 site in Turkey. Open to female participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-07-31.

Sponsored by Federation of Breast Diseases Societies · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
460
Ages
20 Years to 80 Years
Sex
Female
01

Study 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.

Read the detailed description

This 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. Our goal is to test if primary surgery improves overall survival in bone only metastasis.

02

Conditions studied

  • Breast Cancer
  • Surgery

Keywords

  • Metastatic breast carcer
  • Bone metastasis
  • surgery
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 460 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Federation of Breast Diseases Societies is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All female patients diagnosed with de novo stage IV breast cancer

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
460 participants (actual)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • Systemic therapy

    Standart chemotherapy

    Drug: Systemic therapy

  • Primary surgery

    Standart surgery

    Procedure: Surgery

  • Neoadjuvant chemotherapy

    Standart chemotherapy followed by surgery

    Procedure: Surgery · Drug: Systemic therapy

Interventions

  • ProcedureSurgery

    Surgery to primary tumor

    Also known as: mastectomy, lumpectomy

  • DrugSystemic therapy

    Systemic therapy based on tumor phenotype

    Also known as: Chemotherapy, hormone therapy, biphosphanetes

06

What researchers measure

Primary outcomes

  1. Overall survival

    Years

    Time frame: 5 years

Secondary outcomes

  1. Locoregional progression

    Number

    Time frame: 5 years

07

Study locations

1 site
  • Istanbul University Medical faculty
    Istanbul, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02125630
Lead sponsor
Federation of Breast Diseases Societies
Responsible party
Sponsor
First posted
Apr 29, 2014
Start date
Jan 2014
Primary completion
Jun 2019
Completion
Jun 2019
Last update
Jul 31, 2019

Study contacts

Atilla Soran, MD, MPH
study chair · University of Pittsburgh
Serdar Ozbas, MD
principal investigator · Guven Hospital
Lutfi Doğan, MD
principal investigator · Ankara Onkoloji Hastanesi

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion