Breast NeoplasmsNCT01271738
Evaluating and Comparing Two Surgical Methods for Treatment of Early Stage Breast Cancer
A study testing Remove tumor only and Removal of tumor and tissue in people with Breast Neoplasms and Breast Cancer, run by Emory University at 1 site in United States.
Trial summary
The goal of this study is to compare two different types of breast surgery. In the first type, the doctor removes only the tumor. In the second type, the doctor removes the tumor and some of the tissue around the tumor called margins. The amount of breast tissue removed is similar. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Breast Cancer, Breast Tumors
- What is being tested?
- Remove tumor only and Removal of tumor and tissue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Feb 2015
- Phase
- Interventional
- 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
Who may be able to join
- Female Patients with the diagnosis of Stage 0, I, II and III breast cancer diagnosed/treated at the AVON Foundation Comprehensive Breast Center (AFCBC) of Grady Memorial Hospital
- Age: no limit
Who cannot join
- Stage IV breast cancers
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
About this study
Official title: Measuring the Effect of Additional Tumor Cavity Margins Excision at the Time of Breast Conserving Surgery for Stage 0, I, II, and III Breast Cancer Patients on Re-excision Rate, Cosmetic Results and Total Costs
The goal of this study is to compare two different types of breast surgery. In the first type, the doctor removes only the tumor. In the second type, the doctor removes the tumor and some of the tissue around the tumor called margins. The amount of breast tissue removed is similar. The removal of the tumor only has up to 40% chance of reoperation because the tumor is too close to the margin. The primary goal of this study is to see if the additional margins can decrease the need to return to the operating room. Both types of surgery are well accepted, and participating in the study would not give you a better chance to cure the cancer. At present, most breast surgeons remove the tumor without the additional margins. For all patients who have this operation, there is a high incidence of return to the operating room for margins re-excision: as many as 40% as patients can have a re-operation.
At present, we do not know if taking the additional margins prevents the cancer from returning in the breast or not. If the cancer comes back in your breast, this is a recurrence and your breast will have to be removed (mastectomy).
- Conditions
- Breast Neoplasms, Breast Cancer, Breast Tumors, Cancer of Breast, Cancer of the Breast, Human Mammary Carcinoma
- Being tested
- Remove tumor only, Removal of tumor and tissue
- Keywords
- Breast Cancer, Tumors or cancer of the human breast, Breast Tumors, Cancer of Breast, Cancer of the Breast, Human Mammary Carcinoma, Neoplasms, Breast
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remove tumor onlyProcedure or surgery
No additional margins (tissue) removed at the initial surgery
Removal of tumor and tissueProcedure or surgery
5 additional margins (tissue) removed at the time of surgery
| Study group | Role | What they receive |
|---|---|---|
| Breast Conserving Surgery (BCS) | Active comparator | Not described Receives: Procedure: Remove tumor only |
| Breast Conserving Surgery with Additional 5 Margins (BCS + M) | Active comparator | Not described Receives: Procedure: Removal of tumor and tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing 2 surgical methods for treatment of early stage breast cancer
The investigator will survey patients with the cosmetic assessment survey after the surgical procedure.
Measured: Post operative evaluation will be at 30 days, then at 4-7 months and last at 12-15 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startSep 2009
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica Rizzo, Emory University
- Investigators
- Monica Rizzo, MD, Principal investigator, EmoryUniversity Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271738
- Sponsor's protocol ID
- IRB00013658
- Other IDs
- WCI1659-09
- Status last verified
- Aug 2015
- First submitted
- 6 Dec 2010
- Last updated
- 17 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Effect of Additional Tumor Cavity Margins Excision at the Time of Breast Conserving Surgery for Stage 0, I, II, and III Breast Cancer Patients on Re-excision Rate, Cosmetic Results and Total Costs
- ClinicalTrials.gov ID
- NCT01271738
- Acronym / sponsor ID
- IRB00013658
- Conditions
- Breast Neoplasms, Breast Cancer, Breast Tumors, Cancer of Breast, Cancer of the Breast, Human Mammary Carcinoma
- Keywords
- Breast Cancer, Tumors or cancer of the human breast, Breast Tumors, Cancer of Breast, Cancer of the Breast, Human Mammary Carcinoma, Neoplasms, Breast
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 7 Jan 2011 (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 goal of this study is to compare two different types of breast surgery. In the first type, the doctor removes only the tumor. In the second type, the doctor removes the tumor and some of the tissue around the tumor called margins. The amount of breast tissue removed is similar. The removal of the tumor only has up to 40% chance of reoperation because the tumor is too close to the margin. The primary goal of this study is to see if the additional margins can decrease the need to return to the operating room. Both types of surgery are well accepted, and participating in the study would not give you a better chance to cure the cancer. At present, most breast surgeons remove the tumor without the additional margins. For all patients who have this operation, there is a high incidence of return to the operating room for margins re-excision: as many as 40% as patients can have a re-operation.
At present, we do not know if taking the additional margins prevents the cancer from returning in the breast or not. If the cancer comes back in your breast, this is a recurrence and your breast will have to be removed (mastectomy).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Conserving Surgery (BCS) | Active comparator | Procedure: Remove tumor only |
| Breast Conserving Surgery with Additional 5 Margins (BCS + M) | Active comparator | Procedure: Removal of tumor and tissue |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female Patients with the diagnosis of Stage 0, I, II and III breast cancer diagnosed/treated at the AVON Foundation Comprehensive Breast Center (AFCBC) of Grady Memorial Hospital
- Age: no limit
Key exclusion criteria (1 listed)
- Stage IV breast cancers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remove tumor onlyNo additional margins (tissue) removed at the initial surgery | Procedure or surgery | Breast Conserving Surgery (BCS) |
| Removal of tumor and tissue5 additional margins (tissue) removed at the time of surgery | Procedure or surgery | Breast Conserving Surgery with Additional 5 Margins (BCS + M) |
Primary outcome
Comparing 2 surgical methods for treatment of early stage breast cancer
Time frame: Post operative evaluation will be at 30 days, then at 4-7 months and last at 12-15 months.
The investigator will survey patients with the cosmetic assessment survey after the surgical procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
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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.
Monica Rizzo, MD principal investigator
EmoryUniversity Winship Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remove tumor only and Removal of tumor and tissue in people with Breast Neoplasms and Breast Cancer, run by Emory University at 1 site in United States.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 17 Aug 2015. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparing 2 surgical methods for treatment of early stage breast cancer (time frame: Post operative evaluation will be at 30 days, then at 4-7 months and last at 12-15 months.). 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 Aug 2015.