Bone Metastasis and Surgery in Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

460 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2019-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Systemic therapy

Standart chemotherapy

Systemic therapy

Intervention Type DRUG

Systemic therapy based on tumor phenotype

Primary surgery

Standart surgery

Surgery

Intervention Type PROCEDURE

Surgery to primary tumor

Neoadjuvant chemotherapy

Standart chemotherapy followed by surgery

Surgery

Intervention Type PROCEDURE

Surgery to primary tumor

Systemic therapy

Intervention Type DRUG

Systemic therapy based on tumor phenotype

Interventions

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Surgery

Surgery to primary tumor

Intervention Type PROCEDURE

Systemic therapy

Systemic therapy based on tumor phenotype

Intervention Type DRUG

Other Intervention Names

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mastectomy, lumpectomy Chemotherapy, hormone therapy, biphosphanetes

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No