Analysis of Surgery in Patients Presenting With Stage IV Breast Cancer

A Prospective Analysis of Surgery in Patients Presenting With Stage IV Breast Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00941759

Enrollment

100

Registered

2009-07-20

Start date

2009-07-31

Completion date

2023-07-10

Last updated

2025-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast, Blood and tissue collection, Epidemiologic, Questionnaire, TBCRC (Translational Breast Cancer Research Consortium), 09-056

Brief summary

The purpose of this study is to study patients presenting with stage IV breast cancer. Stage IV means that the breast cancer has spread to another part of the body outside the breast. This study is important because in different parts of the country some patients are being offered surgical treatment for the breast tumor and some are not. The doctors do not know if surgery for the breast tumor is helpful in patients with stage IV breast cancer. The doctors will collect information about the patient and their treatment to learn more about how patients and doctors make treatment decisions. The doctor will also collect blood samples and tissue samples for laboratory studies to learn more about tumors that have spread to other parts of the body.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age 18 years or older * Known or suspected Stage IV breast cancer with intact primary tumor * Known or suspected Stage IV breast cancer with intact primary tumor, having begun systemic therapy within the past 12 months * Known or suspected Stage IV breast cancer within 3 months of local breast surgery * Known or suspected Stage IV breast cancer within 3 months of local breast surgery, having begun systemic therapy within the past 12 months

Exclusion criteria

* Primary breast cancer diagnosis made by FNA only and no pre-treatment core biopsy planned for diagnostic or research purposes. * Failure of MSKCC or participating site to confirm Stage IV breast cancer diagnosis by biopsy within 30 days of study enrollment

Design outcomes

Primary

Measure	Time frame
Measure response to first-line therapy, frequency of surgical referral and the proportion of patients who undergo surgery of the primary tumor in stage IV disease.	2 years

Secondary

Measure	Time frame
Determine the incidence of uncontrolled local disease in patients who do/do not undergo surgery.	2 years
Correlate molecular characteristics of the primary tumor with conventional prognostic factors and survival in patients presenting with stage IV breast cancer.	2 years
Perform correlative molecular studies of circulating tumor cells, primary and metastatic tumor samples in stage IV breast cancer.	2 years

Countries

United States

Outcome results