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

This study has been terminated.
(Too low inclusion rate)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02017496
First Posted: December 20, 2013
Last Update Posted: October 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bjørn Naume, Oslo University Hospital
  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 Bjørn Naume, 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) ]
    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) ]
    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)

Enrollment: 18
Actual Study Start Date: October 2011
Study Completion Date: December 2015
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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02017496


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

Responsible Party: Bjørn Naume, Principal investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02017496     History of Changes
Other Study ID Numbers: S-08450d
First Submitted: October 23, 2013
First Posted: December 20, 2013
Last Update Posted: October 17, 2017
Last Verified: October 2017

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

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