Safety of Breast Conserving Treatment in Locally Advanced Breast Cancer Receiving Neoadjuvant Treatment (NeoBCT)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Safety of Breast Conserving Treatment in Locally Advanced Breast Cancer Receiving Neoadjuvant Treatment|
- 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 [ Time Frame: 24 weeks after start of neoadjuvant treatment (at surgery) ] [ Designated as safety issue: No ]The surgical specimens will be analysed after surgery, and the results of these analyses will be the basis for the final end point measurements.
- Tumor molecular marker characteristics related to complete resection by BCT [ Time Frame: 24 weeks after start of neoadjuvant treatment (at surgery) ] [ Designated as safety issue: No ]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
Biospecimen Retention: Samples With DNA
Sampling of primary tumor DNA and RNA is not included as a study specific procedure, but if the patient is included in a different ongoing protocol with tumor sampling, there is approval/allowance for using tumor tissue for the purpose of the current study (characteristics of the primary tumor that may predict residual tumor pattern and BCT success)
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02017496
|Contact: Bjørn Naume, Professor||+47 firstname.lastname@example.org|
|Oslo University Hospital||Recruiting|
|Oslo, Norway, 0424|
|Principal Investigator: Bjørn Naume, Professor|
|Principal Investigator:||Bjørn Naume, Professor||Oslo University Hospital|