Male Breast CancerNCT01222377
Endoscopic Breast Surgery in Treating Patients With Breast Cancer
A study testing endoscopic surgery and quality-of-life assessment in people with Male Breast Cancer and Recurrent Breast Cancer, run by University of Southern California at 1 site in United States.
Trial summary
RATIONALE: Endoscopic breast surgery (EBS) is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. PURPOSE: This clinical trial studies endoscopic breast surgery in treating patients with breast cancer. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Male Breast Cancer, Recurrent Breast Cancer, Stage IA Breast Cancer
- What is being tested?
- endoscopic surgery and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Oct 2011
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Breast cancer or prophylactic mastectomy requiring axillary nodal staging
- Breast disease (e.g., fibroadenoma, ADH)
- Ability to read and/or comprehend consent form and questionnaires
- Ability to follow-up per protocol
- Not pregnant or breastfeeding
Who cannot join
- Pregnant or breastfeeding
- Evidence of chest wall or skin* involvement
- NOTE: *may be endoscopy-assisted
Trial locations and contacts
1 site in 1 country.
United States1 site
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Endoscopic Breast Surgery Feasibility Study
RATIONALE: Endoscopic breast surgery (EBS) is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. PURPOSE: This clinical trial studies endoscopic breast surgery in treating patients with breast cancer.
Read the detailed description
PRIMARY OBJECTIVES: I. To determine the surgical complication rate in patients undergoing EBS for benign or malignant disease and the 5-year local recurrence rate following endoscopic breast surgery among subjects undergoing EBS for breast cancer at USC. SECONDARY OBJECTIVES: I. To evaluate the safety, breast cosmesis and patient quality of life following EBS. OUTLINE: Patients undergo endoscopic breast surgery. After completion of study treatment, patients are followed up every 6 months for 5 years.
- Conditions
- Male Breast Cancer, Recurrent Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer
- Being tested
- endoscopic surgery, quality-of-life assessment
- Medical subject headings
- Breast Neoplasms, Male, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic surgeryProcedure or surgery
Also called surgery, endoscopic
Undergo endoscopic breast surgery
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients undergo endoscopic breast surgery. Receives: Procedure: endoscopic surgery; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the surgical complication rate among all patients having EBS and the local recurrence rate among patients with breast cancer
Measured: 5 years
Secondary outcomes (1)
To evaluate the safety, breast cosmesis and patient quality of life following EBS
Measured: After completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: P.I. left
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Dennis Holmes, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222377
- Sponsor's protocol ID
- 1B-09-14
- Other IDs
- NCI-2010-02088
- Status last verified
- Feb 2014
- First submitted
- 14 Oct 2010
- Last updated
- 6 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Breast Surgery Feasibility Study
- ClinicalTrials.gov ID
- NCT01222377
- Acronym / sponsor ID
- 1B-09-14
- Conditions
- Male Breast Cancer, Recurrent Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: P.I. left
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 18 Oct 2010 (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.
RATIONALE: Endoscopic breast surgery (EBS) is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. PURPOSE: This clinical trial studies endoscopic breast surgery in treating patients with breast cancer.
Detailed description
PRIMARY OBJECTIVES: I. To determine the surgical complication rate in patients undergoing EBS for benign or malignant disease and the 5-year local recurrence rate following endoscopic breast surgery among subjects undergoing EBS for breast cancer at USC. SECONDARY OBJECTIVES: I. To evaluate the safety, breast cosmesis and patient quality of life following EBS. OUTLINE: Patients undergo endoscopic breast surgery. After completion of study treatment, patients are followed up every 6 months for 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Procedure: endoscopic surgery, Procedure: quality-of-life assessmentPatients undergo endoscopic breast surgery. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Breast cancer or prophylactic mastectomy requiring axillary nodal staging
- Breast disease (e.g., fibroadenoma, ADH)
- Ability to read and/or comprehend consent form and questionnaires
- Ability to follow-up per protocol
- Not pregnant or breastfeeding
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding
- Evidence of chest wall or skin* involvement
- NOTE: *may be endoscopy-assisted
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 |
|---|---|---|
| endoscopic surgeryAlso: surgery, endoscopicUndergo endoscopic breast surgery | Procedure or surgery | Arm I |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Arm I |
Primary outcome
To estimate the surgical complication rate among all patients having EBS and the local recurrence rate among patients with breast cancer
Time frame: 5 years
1 secondary outcome
To evaluate the safety, breast cosmesis and patient quality of life following EBS
Time frame: After completion of study treatment
Results and safety
The study was stopped early (reason given: P.I. left). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2014.
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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.
Dennis Holmes principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic surgery and quality-of-life assessment in people with Male Breast Cancer and Recurrent Breast Cancer, run by University of Southern California 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 5 inclusion and 3 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 6 Feb 2014. 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 was stopped early (reason given: P.I. left). 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?
To estimate the surgical complication rate among all patients having EBS and the local recurrence rate among patients with breast cancer (time frame: 5 years). 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 6 Feb 2014.