Breast CancerNeoBCTNCT02017496
Safety of Breast Conserving Treatment in Locally Advanced Breast Cancer Receiving Neoadjuvant Treatment
An observational study of Breast Cancer, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 18 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2011to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to neoadjuvant treatment at the University Hospitals in Norway who are candidates for neoadjuvant treatment.
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, locally advanced, neoadjuvant treatment, breast conserving surgery
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks after start of neoadjuvant treatment (at surgery)
Secondary outcomes (1)
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
Measured: 24 weeks after start of neoadjuvant treatment (at surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startOct 2011
- Primary completionDec 2014
- Study completionDec 2015
Why it stopped: Too low inclusion rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bjørn Naume, Oslo University Hospital
- Investigators
- Bjørn Naume, Professor, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017496
- Sponsor's protocol ID
- S-08450d
- Acronym
- NeoBCT
- Status last verified
- Oct 2017
- First submitted
- 23 Oct 2013
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Breast Conserving Treatment in Locally Advanced Breast Cancer Receiving Neoadjuvant Treatment
- ClinicalTrials.gov ID
- NCT02017496
- Acronym / sponsor ID
- NeoBCT / S-08450d
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, locally advanced, neoadjuvant treatment, breast conserving surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Too low inclusion rate
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Oct 2011 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to neoadjuvant treatment at the University Hospitals in Norway who are candidates for neoadjuvant treatment.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Tumor molecular marker characteristics related to complete resection by BCT
Time frame: 24 weeks after start of neoadjuvant treatment (at surgery)
Results and safety
The study was stopped early (reason given: Too low inclusion rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bjørn Naume, Professor principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Too low inclusion rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2017.