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

NCT02017496 | Terminated

• 1 other identifier: S-08450d
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast cancer; locally advanced; neoadjuvant treatment; breast conserving surgery

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Tumor molecular marker characteristics related to complete resection by BCT

  24 weeks after start of neoadjuvant treatment (at surgery)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

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)

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Bjørn Naume, Professor

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: December 20, 2013
• Study Start: October 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: October 17, 2017

Record last verified: 2017-10

Locations

NO (1)