Local Surgery for Metastatic 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

Clinical Phase

NA

Total Enrollment

281 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2012-11-30

Brief Summary

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Primary treatments for metastatic breast cancer are chemotherapy and radiation therapy, and surgery is reserved for tumor related complications such as bleeding. Retrospective studies showed that surgical removal of the primary tumor improves survival of patients with metastatic breast cancer at diagnosis. We hypothesis and testing that surgical removal of the primary tumor will lead to an improvement of overall survival

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Detailed Description

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This is a randomised, controled clinical trial. Our aim is to observe whether primary surgery improves survival in metastatic breast cancer. Women who have metastatic breast cancer at the initial diagnosis will be included in the study. There will be two study arms: primary surgery and systemic chemotherapy groups.

In the primary surgery group patients will have adjuvant therapies after they had the proper surgery. In the systemic chemotherapy group patients will be followed after their initial therapy and will have surgery only if they have locoregional problems (such as wide necrosis or bleeding, etc). During the follow-up period, patients will be seen in every 6 months.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Standard Systemic Therapy only group (no primary surgery)

Group Type NO_INTERVENTION

No interventions assigned to this group

B

Surgery group

Group Type OTHER

Primary surgery

Intervention Type PROCEDURE

Primary breast surgery before systemic therapy

Interventions

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Primary surgery

Primary breast surgery before systemic therapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women with metastatic breast cancer at the initial diagnosis

Exclusion Criteria

* Women needs breast surgery at the time of initial diagnosis (such as bleeding, necrosis, etc)
* who have systemic morbidity that do not allows her to be in the trial,
* who have synchronous breast cancer at the contralateral breast,
* who have a previous cancer history or another primary cancer history and metastasis at the past,
* who have palpable lymph node/nodes at the contralateral axilla,
* who do not agree to participate the trial

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No