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Safety of Breast Conserving Treatment in Locally Advanced Breast Cancer Receiving Neoadjuvant Treatment

NCT ID: NCT02017496

Last Updated: 2017-10-17

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

TERMINATED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-12-31

Brief Summary

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The study explores the safety of breast conserving treatment (BCT)(defined as complete removal of tumor deposits) after neoadjuvant treatment for locally advanced breast cancer.

Detailed Description

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The standard breast surgical procedure of locally advanced breast cancer in Norway is mastectomy. There is increasing interest in performing breast conserving treatment (BCT) in locally advanced cases after chemotherapy or hormonal treatment - if there is a partial or complete clinical remission. To increase the evidence for the safety (no residual tumor) of such a procedure directly compared to mastectomy without compromising the safety of the treatment, a breast preserving procedure followed by an immediate mastectomy can be performed within a study. It would then be possible to study the margins after the breast preserving procedure as well as the tumor status in the rest of the breast.

Patients included in the study will receive neoadjuvant treatment followed by evaluation of the tumor reduction by magnetic resonance imaging (MRI) and selection of BCT candidates. Candidates will be prepared for BCT, and during the surgical procedure, BCT will be performed (as one surgical specimen) followed by immediate removal of the rest of the breast tissue (mastectomy). The BCT specimen and mastectomy specimen will be analysed for residual tumor cells. The tumor removal completeness of the BCT procedure can be evaluated, with comparison to the clinical and primary tumor characteristics, including analysis of the tumor biopsies and imaging before and during the neoadjuvant treatment, for selection of candidates for BCT in the future.

Conditions

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Breast Cancer

Keywords

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Breast cancer locally advanced neoadjuvant treatment breast conserving surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients with locally advanced breast cancer (cT3-4c, N0-3) with tumors \> 5 cm, as determined by MRI, where the present guidelines include them for neoadjuvant systemic therapy
* Written informed consent (informed consent document to be approved by the Independent Ethics Committee) prior to study-related procedures and examinations.
* Female age \> 18 years
* Able to comply with the protocol
* Histologically confirmed adenocarcinoma of the breast
* American Society of Anesthesiologist's physical status category 1 or 2 before surgery. Category 1 and 2 includes healthy patients and patients with only mild systemic disease, whereas category 3 includes patients with more serious systemic diseases (but still operable).

Exclusion Criteria

* Inflammatory breast cancer or diffuse locoregional involvement of the skin
* Stage IV - metastatic disease
* Locoregional relapse of earlier breast cancer
* Inability (irrespective of reason) to receive the recommended neoadjuvant treatment, - as decided by the treating physician.
* American Society of Anesthesiologist's physical status category 4-5
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bjørn Naume

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bjørn Naume, Professor

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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S-08450d

Identifier Type: -

Identifier Source: org_study_id