Clinical trial NCT02125630: Bone Metastasis and Surgery in Breast Cancer
Official title: The Effect of Primary Surgery in Patients With Stage IV Breast Cancer With Bone Metastasis Only
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Surgery
Keywords: Metastatic breast carcer
Bone metastasis
surgery
Lead sponsor: Federation of Breast Diseases Societies
Sponsor class: OTHER
First posted: 2014-04-29
Enrollment: 460
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All female patients diagnosed with de novo stage IV breast cancer

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.

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Locoregional progression
timeFrame: 5 years
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Medical faculty
Study officials:
affiliation: University of Pittsburgh
name: Atilla Soran, MD, MPH
role: STUDY_CHAIR
affiliation: Guven Hospital
name: Serdar Ozbas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara Onkoloji Hastanesi
name: Lutfi Doğan, MD
role: PRINCIPAL_INVESTIGATOR
References: