Breast CancerPhase 3GRATSECNCT01035268
Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella
A Phase 3 study testing fatty tissue transfer in people with Breast Cancer, run by Institut Claudius Regaud at 23 sites in France.
Trial summary
This is a phase III randomized multi-center study of equivalence comparing the radiological follow-up for patients benefiting from the correction of the esthetical relapse of the preservative treatment by fatty transfer compared with a simple supervision. 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?
- fatty tissue transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 23 sitesFrance
- Study dates
- 8 Feb 2010to 21 Feb 2017
- Phase
- Phase 3
- 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
- History of breast cancer treated by conservative surgery .
- Normal inclusion radiological assessment normal (ACR1 or ACR2)
- Moderate Deformations (Type I and II of the classification of Clough).
- Delay with regard to the end of the radiotherapy superior or equal to one-year-old.
- Moderated radio-dystrophies (< Grade 2 of the score LENT/SOMA).
- Signature of the informed consent
- Patient benefiting from social security
- Patient of more than 18 years old
Who cannot join
- Abnormal radiological assessment (ACR3, ACR4 or ACR5)
- Absence of fatty excess .
- radio surgical relapses with vast fibroses of the breast (> Grade 2 of the score LENT/SOMA).
- Patient under 18 years old.
- administrative difficulties: impossibility to provide enlightened information to the patient, the refusal to sign the consent .
- pregnant women or breast feeding women
- patient under legal guardianship
- bilateral breast cancer regardless histologic type.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
France23 sites
CHU de Besançon
Besançon, 25030
Clinique Saint Antoine
Bois-Guillaume, 76230
CHU Pellegrin
Bordeaux, 33076
Institut Bergonie
Bordeaux, 33076
Pole de Sante de Leonard de Vinci
Chambray-lès-Tours, 37145
Hopital Henri Mondor
Créteil, 94010
Centre Hospitalier La Croix Rousse
Lyon, 69004
Hopital Edouard Herriot
Lyon, 69437
CHR Marseille Conception
Marseille, 13005
Institut Paoli Calmettes
Marseille, 13273
Centre Val d'Aurelle
Montpellier, 34298
Clinique Brétéché
Nantes, 44000
INSTITUT CURIE - Site Paris
Paris, 75005
Hopital Saint Louis
Paris, 75010
Centre Eugene Marquis
Rennes, 35042
Centre Henri Becquerel
Rouen, 76038
INSTITUT CURIE - René Huguenin
Saint-Cloud, 92210
INSTITUT DE CANCEROLOGIE DE L'OUEST - Centre René Gauducheau
Saint-Herblain, 44805
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
CHU Rangueil
Toulouse, 31000
Institut Claudius Regaud
Toulouse, 31059
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella. Adipocyte Transplant for Esthetical Relapse Treatment of Breast Conservative Treatment
This is a phase III randomized multi-center study of equivalence comparing the radiological follow-up for patients benefiting from the correction of the esthetical relapse of the preservative treatment by fatty transfer compared with a simple supervision.
It is planned that 440 patients participate in this study which plans to compare 2 groups of patients: a group of patients which will benefit from the surgical treatment by transfer of fatty tissue and a group of patients under simple supervision.
Read more
follow-up consultations are planned in 10 in 45 days post-surgery then at 3 months, 6 months, 12 months and 5 years to look for the expected unwanted effects in relation with the surgery but also to estimate the impact of the fatty transfer on the rate of local and\or from a distance relapse.
During these consultations, the surgeon and the patient will also estimate the cosmetic result of the surgery thanks to a questionnaire of cosmetic evaluation and to standardized photos.
- Conditions
- Breast Cancer
- Being tested
- fatty tissue transfer
- Keywords
- breast cancer treated by conservative surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fatty tissue transferProcedure or surgery
It will be proceeded to aspiration of the fat at the level of the natural steatomeries (hip, stomach), then in a transfer of the fat prepared in the breast by following the standardized protocol.
| Study group | Role | What they receive |
|---|---|---|
| surgery by fatty tissue transfer | Experimental | Not described Receives: Procedure: fatty tissue transfer |
| simple supervision | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verify that the disturbances of the radiological follow-up in 1 year will not be more frequent for the patient benefiting from fatty transfer with regard to a simple surveillance.
Measured: 1 year
Secondary outcomes (2)
Estimate the technique on the cosmetic plan : On the quality and on the stability of the result. On the satisfaction of the patient.
Measured: 1 year
Estimate the technique on the carcinological plan : Estimate the rate of local relapse and\or in distance. Estimate the rate of survival of the patients.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2009 (estimated)
- Study start8 Feb 2010
- Primary completionOct 2015
- Study completion21 Feb 2017
Why it stopped: Slow recruitment 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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ignacio GARRIDO, MD, Principal investigator, Institut Claudius Regaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01035268
- Sponsor's protocol ID
- 08 SEIN 08
- Acronym
- GRATSEC
- Status last verified
- Aug 2018
- First submitted
- 14 Dec 2009
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella. Adipocyte Transplant for Esthetical Relapse Treatment of Breast Conservative Treatment
- ClinicalTrials.gov ID
- NCT01035268
- Acronym / sponsor ID
- GRATSEC / 08 SEIN 08
- Conditions
- Breast Cancer
- Keywords
- breast cancer treated by conservative surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment rate
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 8 Feb 2010 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- 21 Feb 2017 (actual)
- First posted
- 18 Dec 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.
This is a phase III randomized multi-center study of equivalence comparing the radiological follow-up for patients benefiting from the correction of the esthetical relapse of the preservative treatment by fatty transfer compared with a simple supervision.
It is planned that 440 patients participate in this study which plans to compare 2 groups of patients: a group of patients which will benefit from the surgical treatment by transfer of fatty tissue and a group of patients under simple supervision.
follow-up consultations are planned in 10 in 45 days post-surgery then at 3 months, 6 months, 12 months and 5 years to look for the expected unwanted effects in relation with the surgery but also to estimate the impact of the fatty transfer on the rate of local and\or from a distance relapse.
During these consultations, the surgeon and the patient will also estimate the cosmetic result of the surgery thanks to a questionnaire of cosmetic evaluation and to standardized photos.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery by fatty tissue transfer | Experimental | Procedure: fatty tissue transfer |
| simple supervision | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- History of breast cancer treated by conservative surgery .
- Normal inclusion radiological assessment normal (ACR1 or ACR2)
- Moderate Deformations (Type I and II of the classification of Clough).
- Delay with regard to the end of the radiotherapy superior or equal to one-year-old.
- Moderated radio-dystrophies (< Grade 2 of the score LENT/SOMA).
Key exclusion criteria (8 listed)
- Abnormal radiological assessment (ACR3, ACR4 or ACR5)
- Absence of fatty excess .
- radio surgical relapses with vast fibroses of the breast (> Grade 2 of the score LENT/SOMA).
- Patient under 18 years old.
- administrative difficulties: impossibility to provide enlightened information to the patient, the refusal to sign the consent .
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 |
|---|---|---|
| fatty tissue transferIt will be proceeded to aspiration of the fat at the level of the natural steatomeries (hip, stomach), then in a transfer of the fat prepared in the breast by following the standardized protocol. | Procedure or surgery | surgery by fatty tissue transfer |
Primary outcome
Verify that the disturbances of the radiological follow-up in 1 year will not be more frequent for the patient benefiting from fatty transfer with regard to a simple surveillance.
Time frame: 1 year
2 secondary outcomes
Estimate the technique on the cosmetic plan : On the quality and on the stability of the result. On the satisfaction of the patient.
Time frame: 1 year
Estimate the technique on the carcinological plan : Estimate the rate of local relapse and\or in distance. Estimate the rate of survival of the patients.
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Slow recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Ignacio GARRIDO, MD principal investigator
Institut Claudius Regaud
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fatty tissue transfer in people with Breast Cancer, run by Institut Claudius Regaud at 23 sites 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 8 inclusion and 8 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 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Slow recruitment 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?
Verify that the disturbances of the radiological follow-up in 1 year will not be more frequent for the patient benefiting from fatty transfer with regard to a simple surveillance. (time frame: 1 year). 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 22 Aug 2018.