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

Terminated

• Conditions: Breast Cancer

• Registration Number: NCT02017496
• Lead Sponsor: Oslo University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2013-10-23
• Study First Submitted QC: 2013-12-16
• Study First Posted: 2013-12-20
• Primary Completion: 2014-12
• Study Completion: 2015-12
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-16
• Last Update Posted: 2017-10-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1 The presence of viable tumor cells at the margins and in the mastectomy specimen after conducted breast preserving resection followed by mastectomy in the same procedure	24 weeks after start of neoadjuvant treatment (at surgery)	The surgical specimens will be analysed after surgery, and the results of these analyses will be the basis for the final end point measurements.

Secondary Outcome Measures

Name	Time	Method
Tumor molecular marker characteristics related to complete resection by BCT	24 weeks after start of neoadjuvant treatment (at surgery)	Tumor molecular marker characteristics, MRI, mammography (Mx) and ultrasound (US) results and clinical parameters in patients with residual tumor cells in the mastectomy specimen compared to those with no tumor cells

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway