Breast CancerISISNCT02055937
Immediate Implant Breast Reconstruction
A study testing immediate implant breast reconstruction in people with Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
The purpose of this study is to study the impact of the immediate implant breast reconstruction for patients with mastectomy and postoperative chest wall radiotherapy Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- immediate implant breast reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to 30 May 2018
- 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
- Histologically confirmed breast carcinoma
- Patients planned for mastectomy with immediate single stage breast reconstruction using an acellular dermal matrix (Strattice™, LifeCell Corporation)
- Patients planned to receive postoperative chest wall irradiation
- Age ≥ 18 years old
- WHO performance status 0-1
- Affiliation to a social security system
- Informed consent signed prior any study specific procedures
Who cannot join
- Inflammatory breast cancer
- Tumors with extensive involvement of the skin
- Use of tissue expander
- Indication of postoperative chemotherapy
- Patients planned for bilateral mastectomy
- History of previously treated ipsilateral breast carcinoma
Show all 12Show fewer
- Usual contraindications for ADM
- Medical debility precluding surgical treatment
- Psychological, social, geographical disorders or any other condition that would preclude study compliance (treatment modalities and study follow-up).
- Pregnancy or breast feeding
- Inability to attend or comply with interventions or follow-up scheduling, disability or difficulty preventing a proper understanding of trial instructions
- Legal inability or restricted legal ability
Trial locations and contacts
1 site in 1 country.
France1 site
Institut régional du Cancer - Montpellier - Val d'Aurelle
Montpellier, 34000
About this study
Official title: Immediate Implant Breast Reconstruction for Patients With Mastectomy Ans Post opérative Chest Wall Radiotherapy
The purpose of this study is to study the impact of the immediate implant breast reconstruction for patients with mastectomy and postoperative chest wall radiotherapy
Read the detailed description
non applicable
- Conditions
- Breast Cancer
- Being tested
- immediate implant breast reconstruction
- Keywords
- mastectomy, reconstruction
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate implant breast reconstructionProcedure or surgery
Eligible patients will undergo radical mastectomy with axillary lymph nodes sampling followed by immediate and single-stage breast reconstruction using the acellular dermal matrix Strattice™
| Study group | Role | What they receive |
|---|---|---|
| immediate implant breast reconstruction | Experimental | immediate implant breast reconstruction Receives: Procedure: immediate implant breast reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success is defined as a complete therapeutic sequence (surgery + RT) without any significant complication at 6 months.
Success is defined as a complete therapeutic sequence (surgery + RT) without any significant complication at 6 months.
Significant complication is defined as:
- Any event delaying RT (delay surgery/RT > 3 months)
- Any event preventing patients from receiving radiotherapy within 6 months after surgery
Measured: confirm the feasibility of the therapeutic sequence at 6 months
Secondary outcomes (1)
The rate of Baker
The rate of Baker grades 3/4 capsular contracture
Measured: up to 36 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startOct 2013
- Primary completionOct 2015
- Study completion30 May 2018
Why it stopped: autorities vorbidden this dispositif in other trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055937
- Sponsor's protocol ID
- VA2012/37
- Other IDs
- 2012-A01369-34
- Acronym
- ISIS
- Status last verified
- Aug 2020
- First submitted
- 9 Oct 2013
- Last updated
- 10 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Christian CK, Niland J, Edge SB, Ottesen RA, Hughes ME, Theriault R, Wilson J, Hergrueter CA, Weeks JC. A multi-institutional analysis of the socioeconomic determinants of breast reconstruction: a study of the National Comprehensive Cancer Network. Ann Surg. 2006 Feb;243(2):241-9. doi: 10.1097/01.sla.0000197738.63512.23.
PubMed 16432358Lambert K, Mokbel K. Does post-mastectomy radiotherapy represent a contraindication to skin-sparing mastectomy and immediate reconstruction: an update. Surg Oncol. 2012 Jun;21(2):e67-74. doi: 10.1016/j.suronc.2011.12.007. Epub 2012 Jan 30.
PubMed 22296996
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Implant Breast Reconstruction for Patients With Mastectomy Ans Post opérative Chest Wall Radiotherapy
- ClinicalTrials.gov ID
- NCT02055937
- Acronym / sponsor ID
- ISIS / VA2012/37
- Conditions
- Breast Cancer
- Keywords
- mastectomy, reconstruction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: autorities vorbidden this dispositif in other trial
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 5 Feb 2014 (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 purpose of this study is to study the impact of the immediate implant breast reconstruction for patients with mastectomy and postoperative chest wall radiotherapy
Detailed description
non applicable
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| immediate implant breast reconstruction | Experimental | Procedure: immediate implant breast reconstructionimmediate implant breast reconstruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed breast carcinoma
- Patients planned for mastectomy with immediate single stage breast reconstruction using an acellular dermal matrix (Strattice™, LifeCell Corporation)
- Patients planned to receive postoperative chest wall irradiation
- Age ≥ 18 years old
- WHO performance status 0-1
Key exclusion criteria (12 listed)
- Inflammatory breast cancer
- Tumors with extensive involvement of the skin
- Use of tissue expander
- Indication of postoperative chemotherapy
- Patients planned for bilateral mastectomy
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 |
|---|---|---|
| immediate implant breast reconstructionEligible patients will undergo radical mastectomy with axillary lymph nodes sampling followed by immediate and single-stage breast reconstruction using the acellular dermal matrix Strattice™ | Procedure or surgery | immediate implant breast reconstruction |
Primary outcome
Success is defined as a complete therapeutic sequence (surgery + RT) without any significant complication at 6 months.
Time frame: confirm the feasibility of the therapeutic sequence at 6 months
Success is defined as a complete therapeutic sequence (surgery + RT) without any significant complication at 6 months. Significant complication is defined as: * Any event delaying RT (delay surgery/RT > 3 months) * Any event preventing patients from receiving radiotherapy within 6 months after surgery
1 secondary outcome
The rate of Baker
Time frame: up to 36 months after surgery
Results and safety
The study was stopped early (reason given: autorities vorbidden this dispositif in other trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
- Background: PubMed 16432358Christian CK, Niland J, Edge SB, Ottesen RA, Hughes ME, Theriault R, Wilson J, Hergrueter CA, Weeks JC. A multi-institutional analysis of the socioeconomic determinants of breast reconstruction: a study of the National Comprehensive Cancer Network. Ann Surg. 2006 Feb;243(2):241-9. doi: 10.1097/01.sla.0000197738.63512.23.
- Background: PubMed 22296996Lambert K, Mokbel K. Does post-mastectomy radiotherapy represent a contraindication to skin-sparing mastectomy and immediate reconstruction: an update. Surg Oncol. 2012 Jun;21(2):e67-74. doi: 10.1016/j.suronc.2011.12.007. Epub 2012 Jan 30.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immediate implant breast reconstruction 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?
The sponsor lists 7 inclusion and 12 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 10 Aug 2020. 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.
Are results available for this study?
The study was stopped early (reason given: autorities vorbidden this dispositif in other trial). 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?
Success is defined as a complete therapeutic sequence (surgery + RT) without any significant complication at 6 months. (time frame: confirm the feasibility of the therapeutic sequence at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02055937, which also lists 2 linked publications.
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 10 Aug 2020.