Safety of Breast Conserving Treatment in Locally Advanced... | NCT02017496

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

NCT02017496

Sponsor

Oslo University Hospital

Status

Terminated

Last Update Posted

Oct 17, 2017Actual

Enrollment

18Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Too low inclusion rate

Expanded Access Info

Start Date

Oct 2011Actual

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2015Actual

First Submitted Date

Oct 23, 2013

First Submission Date that Met QC Criteria

Dec 16, 2013

First Posted Date

Dec 20, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2017

Last Update Posted Date

Oct 17, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

18Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	The surgical specimens will be analysed after surgery, and the results of these analyses will be the basis for the final end point measurements.	24 weeks after start of neoadjuvant treatment (at surgery)

Secondary Outcomes

Measure	Description	Time Frame
Tumor molecular marker characteristics related to complete resection by BCT	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	24 weeks after start of neoadjuvant treatment (at surgery)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients referred to neoadjuvant treatment at the University Hospitals in Norway who are candidates for neoadjuvant treatment.

Sampling Method

Probability Sample

Name	Affiliation	Role
Bjørn Naume, Professor	Oslo University Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital		Oslo		0424	Norway

ID	Term
D001943	Breast Neoplasms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Description

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)