Breast CancerPhase 2NCT00870415
Breast-Conserving Surgery Techniques in Treating Women With Breast Cancer
A Phase 2 study testing quality-of-life assessment and therapeutic conventional surgery in people with Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. PURPOSE: This phase II trial is studying different breast-conserving surgery techniques in treating women with breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- quality-of-life assessment and therapeutic conventional surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2007to Dec 2010
- Phase
- Phase 2
- 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 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Meets 1 of the following criteria:
- Diagnosis of intraductal breast cancer requiring a wide local resection
- Diagnosis of infiltrating ductal breast cancer within range
- Diagnosis of invasive breast cancer that has not responded well to neoadjuvant treatment
- No multicentric tumor
- No gigantomastia
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- No patients subject to a measure of legal protection or unable to express consent
- No patients deprived of liberty by judicial or administrative decision or hospitalized without patient consent
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy to the diseased breast
- No prior adjuvant treatment
- No concurrent participation in another clinical research study
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, 34298
About this study
Official title: Multicenter (Phase II) Study of Oncoplastic Surgical Techniques for Breast Conservation in Breast Cancers
RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery.
PURPOSE: This phase II trial is studying different breast-conserving surgery techniques in treating women with breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Evaluate the percentage of histologically healthy margins maintained during resection in women with breast cancer.
Secondary
- Evaluate local recurrence at 5 years.
- Evaluate aesthetic results.
- Evaluate quality of life using the QLQC30 and BR23 questionnaires.
OUTLINE: This is a multicenter study.
Patients undergo oncoplastic conservative surgery according to defined modalities across the various centers.
Quality of life is assessed periodically.
After completion of study treatment, patients are followed every 6 months for 2 years and then for at least 3 years.
- Conditions
- Breast Cancer
- Being tested
- quality-of-life assessment, therapeutic conventional surgery
- Keywords
- stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIC breast cancer, ductal breast carcinoma, invasive ductal breast carcinoma
- Medical subject headings
- Breast Neoplasms, Carcinoma, Ductal, Breast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality-of-life assessmentProcedure or surgery
therapeutic conventional surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Surgerie | Experimental | Not described Receives: Procedure: quality-of-life assessment; Procedure: therapeutic conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of histologically healthy margins maintained during resection
Measured: From inclusion to end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startApr 2007
- Primary completionApr 2009
- Study completionDec 2010
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 Institut du Cancer de Montpellier - Val d'AurelleThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Rouanet, MD, PhD, Principal investigator, Institut du Cancer de Montpellier - Val d'Aurelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870415
- Sponsor's protocol ID
- CDR0000633327
- Other IDs
- CLCC-PHRC-OP-06, CLCC-VA-2006/32, CLCC-ID-RCB-2006-A00694-47, INCA-RECF0638
- Status last verified
- Aug 2017
- First submitted
- 26 Mar 2009
- Last updated
- 21 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter (Phase II) Study of Oncoplastic Surgical Techniques for Breast Conservation in Breast Cancers
- ClinicalTrials.gov ID
- NCT00870415
- Acronym / sponsor ID
- CDR0000633327
- Conditions
- Breast Cancer
- Keywords
- stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIC breast cancer, ductal breast carcinoma, invasive ductal breast carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 27 Mar 2009 (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: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery.
PURPOSE: This phase II trial is studying different breast-conserving surgery techniques in treating women with breast cancer.
Detailed description
OBJECTIVES:
Primary
- Evaluate the percentage of histologically healthy margins maintained during resection in women with breast cancer.
Secondary
- Evaluate local recurrence at 5 years.
- Evaluate aesthetic results.
- Evaluate quality of life using the QLQC30 and BR23 questionnaires.
OUTLINE: This is a multicenter study.
Patients undergo oncoplastic conservative surgery according to defined modalities across the various centers.
Quality of life is assessed periodically.
After completion of study treatment, patients are followed every 6 months for 2 years and then for at least 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgerie | Experimental | Procedure: quality-of-life assessment, Procedure: therapeutic conventional surgery |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| quality-of-life assessment | Procedure or surgery | Surgerie |
| therapeutic conventional surgery | Procedure or surgery | Surgerie |
Primary outcome
Percentage of histologically healthy margins maintained during resection
Time frame: From inclusion to end of intervention
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 21 Aug 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.
Philippe Rouanet, MD, PhD principal investigator
Institut du Cancer de Montpellier - Val d'Aurelle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing quality-of-life assessment and therapeutic conventional surgery in people with Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 21 Aug 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 France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percentage of histologically healthy margins maintained during resection (time frame: From inclusion to end of intervention). 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 21 Aug 2017.