Safety of Breast Conserving Treatment in Locally Advanced Breast Cancer Receiving Neoadjuvant Treatment (NeoBCT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Oslo University Hospital
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT02017496
First received: October 23, 2013
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety of Breast Conserving Treatment in Locally Advanced Breast Cancer Receiving Neoadjuvant Treatment

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 50
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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02017496

Contacts
Contact: Bjørn Naume, Professor +47 22934000 bna@ous-hf.no

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0424
Principal Investigator: Bjørn Naume, Professor         
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Bjørn Naume, Professor Oslo University Hospital
  More Information

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02017496     History of Changes
Other Study ID Numbers: S-08450d
Study First Received: October 23, 2013
Last Updated: December 16, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Breast cancer
locally advanced
neoadjuvant treatment
breast conserving surgery

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014