Breast CancerAMASTECNCT04270136
Feasibility of Total Mastectomy in Ambulatory Care
A study testing total mastectomy in people with Breast Cancer and Mastectomy, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Breast cancer is the first female cancer in France. Total mastectomy occurred in 30% of breast cancer patient population. The purpose of this study is to evaluate the feasibility of outpatient surgery for the total mastectomy. In France, Ambulatory care is developed as part of the new national health plan. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Mastectomy, Ambulatory Care
- What is being tested?
- total mastectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 12 Sep 2023
- 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
- All patient with an indication of breast non conserving surgery
Who cannot join
- Standard contra-indication for ambulatory care.
- Also bilateral surgery and immediate breast reconstruction.
Trial locations and contacts
1 site in 1 country.
About this study
Breast cancer is the first female cancer in France. Total mastectomy occurred in 30% of breast cancer patient population.
The purpose of this study is to evaluate the feasibility of outpatient surgery for the total mastectomy.
In France, Ambulatory care is developed as part of the new national health plan.
Breast conserving surgery for tumorectomy or partial mastectomy is already done in outpatient vacation.
Total mastectomy is an extension of this surgery, and, as such, underpins the investigator's hypothesis that total mastectomy is feasible in outpatient care .
- Conditions
- Breast Cancer, Mastectomy, Ambulatory Care
- Being tested
- total mastectomy
- Keywords
- Breast Cancer, mastectomy, ambulatory care
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total mastectomyProcedure or surgery
breast cancer non conserving surgery
| Study group | Role | What they receive |
|---|---|---|
| breast cancer mastectomy | Experimental | Not described Receives: Procedure: total mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of ambulatory care after total mastectomy allowed with PADSS score
Post Anaesthetic Discharge Scoring System (PADSS), which considers six criteria: vital signs, ambulation, nausea/vomiting, pain, bleeding and voiding. Each criterion is given a score ranging from 0 to 2. Only patients who achieve a score of 9 or more are considered ready for discharge.
Measured: day 0= day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Jan 2021
- Primary completion12 Sep 2023
- Study completion12 Sep 2023
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 Centre Hospitalier Universitaire, AmiensThe 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier de Beauvais, Centre Hospitalier de Saint-Quentin
- Responsible party
- Sponsor
- Investigators
- Elodie Demblocque, MD, Principal investigator, Centre Hospitalier de BeauvaisAlbine Mancaux, MD, Principal investigator, Centre Hospitalier de BeauvaisPierrick Theret, MD, Principal investigator, CH SAINT-QUENTIN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270136
- Sponsor's protocol ID
- PI2018_843_0061
- Acronym
- AMASTEC
- Status last verified
- Sep 2023
- First submitted
- 12 Feb 2020
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Total Mastectomy in Ambulatory Care
- ClinicalTrials.gov ID
- NCT04270136
- Acronym / sponsor ID
- AMASTEC / PI2018_843_0061
- Conditions
- Breast Cancer, Mastectomy, Ambulatory Care
- Keywords
- Breast Cancer, mastectomy, ambulatory care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Centre Hospitalier de Beauvais, Centre Hospitalier de Saint-Quentin
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 17 Feb 2020 (actual)
- 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.
Breast cancer is the first female cancer in France. Total mastectomy occurred in 30% of breast cancer patient population.
The purpose of this study is to evaluate the feasibility of outpatient surgery for the total mastectomy.
In France, Ambulatory care is developed as part of the new national health plan.
Breast conserving surgery for tumorectomy or partial mastectomy is already done in outpatient vacation.
Total mastectomy is an extension of this surgery, and, as such, underpins the investigator's hypothesis that total mastectomy is feasible in outpatient care .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| breast cancer mastectomy | Experimental | Procedure: total mastectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patient with an indication of breast non conserving surgery
Key exclusion criteria (2 listed)
- Standard contra-indication for ambulatory care.
- Also bilateral surgery and immediate breast reconstruction.
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 |
|---|---|---|
| total mastectomybreast cancer non conserving surgery | Procedure or surgery | breast cancer mastectomy |
Primary outcome
number of ambulatory care after total mastectomy allowed with PADSS score
Time frame: day 0= day of surgery
Post Anaesthetic Discharge Scoring System (PADSS), which considers six criteria: vital signs, ambulation, nausea/vomiting, pain, bleeding and voiding. Each criterion is given a score ranging from 0 to 2. Only patients who achieve a score of 9 or more are considered ready for discharge.
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 13 Sep 2023.
- Individual participant dataSharing planned: No
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.
Elodie Demblocque, MD principal investigator
Centre Hospitalier de Beauvais
Albine Mancaux, MD principal investigator
Centre Hospitalier de Beauvais
Pierrick Theret, MD principal investigator
CH SAINT-QUENTIN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing total mastectomy in people with Breast Cancer and Mastectomy, run by Centre Hospitalier Universitaire, Amiens 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 1 inclusion and 2 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 13 Sep 2023. 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 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?
number of ambulatory care after total mastectomy allowed with PADSS score (time frame: day 0= day of surgery). 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 13 Sep 2023.