Breast Cancer FemaleDREAM-RMINCT05527769
Pain and Functional Recovery After Mastectomy and IBR by Implant: Prepectoral Versus Subpectoral Technique
An observational study of Breast Cancer Female, run by Institut Cancerologie de l'Ouest at 1 site in France.
Trial summary
This is a prospective, single-center, non-randomized study of immediate breast reconstruction (IBR) using a pre- or retro-pectoral technique in patients with breast cancer who have undergone total mastectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- mastectomy + immediate breast reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 7 Sep 2022to 30 Nov 2023
- Phase
- Observational
- 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
Study population: Major patients followed for breast cancer with indication of mastectomy with immediate breast reconstruction by prosthesis.
Who may be able to join
- Major patients
- With breast cancer and indication for total mastectomy
- With a desire for immediate breast reconstruction
- Total mastectomy procedure and Immediate Breast Reconstruction by Pre-pectoral or Retro-Pectoral prosthesis
- Information of the patient and collection of his/her non-opposition
- Affiliation with a social securitý scheme, or beneficiary of such a scheme
Who cannot join
- Prophylactic mastectomies
- Metastatic patients
- Patients requiring another surgical technique
- Person in an emergency situation, person of legal age under legal protection (adult under guardianship, curators or safeguard of justice), or unable to express consent,
- Impossibility to submit to the medical follow-up of the trial for geographical, social or psychological reasons
- Pregnant or likely to be pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study Evaluating Postoperative Pain and Functional Recovery After Mastectomy and Immediate Breast Reconstruction by Implant: Prepectoral Versus Subpectoral Technique
This is a prospective, single-center, non-randomized study of immediate breast reconstruction (IBR) using a pre- or retro-pectoral technique in patients with breast cancer who have undergone total mastectomy.
The technique used is chosen according to the characteristics of the breast, the morphology of the patient and her wishes after informed information on the different techniques. The aim is not to compare the two techniques but rather to evaluate the early functional results of these two methods in order to better understand them and to propose a management adapted to each.
Read more
The main objective will be to evaluate the postoperative pain by BPI questionnaire.
The investigators also wish to observe the functional results of the homolateral upper limb by DASH questionnaire, the quality of life by BREAST Q questionnaire and the occurrence of complications.
Read the detailed description
describe the occurrence of complications between pre-pectoral and retro-pectoral technique in patients with breast cancer who have total mastectomy.
evaluate the postoperative pain by Brief Pain Inventory (BPI) self assesment observe the functional results of the homolateral upper limb by Disabilities of the Arm, Shoulder and Hand (DASH) self assesment observe quality of life by BREAST Q questionary
- Conditions
- Breast Cancer Female
- Being tested
- mastectomy + immediate breast reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mastectomy + immediate breast reconstructionProcedure or surgery
pre- or retro pectoral prosthesis
| Study group | Role | What they receive |
|---|---|---|
| pre-pectoral prosthesis | breast cancer patients with an indication for total mastectomy + immediate breast reconstruction (IBR) by prosthesis using a pre-pectoral technique Receives: Procedure: mastectomy + immediate breast reconstruction | |
| retropectoral prosthesis | breast cancer patients with an indication for total mastectomy + immediate breast reconstruction (IBR) by prosthesis using the retropectoral technique Receives: Procedure: mastectomy + immediate breast reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe postoperative pain and functional results
Brief Pain Inventory (BPI) short form - 4 scales from 1 (No pain) to 10 (max pain) + 7 scales from 1 (no discomfort) to 10 (max discomfort) to determine if the pain interfered with activities of daily living
Measured: 6 month
Secondary outcomes (7)
Assessing quality of life and aesthetic satisfaction
breast questionary pre-post operative reconstruction module
Measured: 6 months
Evaluate the function of the homolateral upper limb
Disabilities of the Arm, Shoulder and Hand self-assessment
Measured: 6 months
Describe the occurrence of postoperative complications
postoperative complications
Measured: 3 months
Describe the length of operative stay (for the initial reconstruction), for all patients and according to the methods of reconstruction performed
duration of hospitalization
Measured: 3 months
Describe the duration of drainage for all patients and according to the methods of reconstruction performed
duration of drainage in the breast and back, number of punctures and total volume of seroma punctures (classification <2)
Measured: 3 months
Describe the number of surgery(s) required to obtain a good aesthetic result
number of surgery(s)
Measured: 3 months
Describe the number of consultations for seroma punctures, for all patients and according to the methods of reconstruction performed
number of punctures and total volume of seroma punctures (classification <2)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start7 Sep 2022
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline RENAUDEAU, MD, Principal investigator, celine.renaudeau@ico.unicancer.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527769
- Sponsor's protocol ID
- ICO-2021-36
- Acronym
- DREAM-RMI
- Status last verified
- Sep 2023
- First submitted
- 29 Aug 2022
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Evaluating Postoperative Pain and Functional Recovery After Mastectomy and Immediate Breast Reconstruction by Implant: Prepectoral Versus Subpectoral Technique
- ClinicalTrials.gov ID
- NCT05527769
- Acronym / sponsor ID
- DREAM-RMI / ICO-2021-36
- Conditions
- Breast Cancer Female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 6 Sep 2022 (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.
This is a prospective, single-center, non-randomized study of immediate breast reconstruction (IBR) using a pre- or retro-pectoral technique in patients with breast cancer who have undergone total mastectomy.
The technique used is chosen according to the characteristics of the breast, the morphology of the patient and her wishes after informed information on the different techniques. The aim is not to compare the two techniques but rather to evaluate the early functional results of these two methods in order to better understand them and to propose a management adapted to each.
The main objective will be to evaluate the postoperative pain by BPI questionnaire.
The investigators also wish to observe the functional results of the homolateral upper limb by DASH questionnaire, the quality of life by BREAST Q questionnaire and the occurrence of complications.
Detailed description
describe the occurrence of complications between pre-pectoral and retro-pectoral technique in patients with breast cancer who have total mastectomy.
evaluate the postoperative pain by Brief Pain Inventory (BPI) self assesment observe the functional results of the homolateral upper limb by Disabilities of the Arm, Shoulder and Hand (DASH) self assesment observe quality of life by BREAST Q questionary
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre-pectoral prosthesis | – | Procedure: mastectomy + immediate breast reconstructionbreast cancer patients with an indication for total mastectomy + immediate breast reconstruction (IBR) by prosthesis using a pre-pectoral technique |
| retropectoral prosthesis | – | Procedure: mastectomy + immediate breast reconstructionbreast cancer patients with an indication for total mastectomy + immediate breast reconstruction (IBR) by prosthesis using the retropectoral technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major patients followed for breast cancer with indication of mastectomy with immediate breast reconstruction by prosthesis.
Key inclusion criteria (6 listed)
- Major patients
- With breast cancer and indication for total mastectomy
- With a desire for immediate breast reconstruction
- Total mastectomy procedure and Immediate Breast Reconstruction by Pre-pectoral or Retro-Pectoral prosthesis
- Information of the patient and collection of his/her non-opposition
Key exclusion criteria (6 listed)
- Prophylactic mastectomies
- Metastatic patients
- Patients requiring another surgical technique
- Person in an emergency situation, person of legal age under legal protection (adult under guardianship, curators or safeguard of justice), or unable to express consent,
- Impossibility to submit to the medical follow-up of the trial for geographical, social or psychological reasons
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 |
|---|---|---|
| mastectomy + immediate breast reconstructionpre- or retro pectoral prosthesis | Procedure or surgery | pre-pectoral prosthesis, retropectoral prosthesis |
Primary outcome
Describe postoperative pain and functional results
Time frame: 6 month
Brief Pain Inventory (BPI) short form - 4 scales from 1 (No pain) to 10 (max pain) + 7 scales from 1 (no discomfort) to 10 (max discomfort) to determine if the pain interfered with activities of daily living
7 secondary outcomes
Assessing quality of life and aesthetic satisfaction
Time frame: 6 months
Evaluate the function of the homolateral upper limb
Time frame: 6 months
Describe the occurrence of postoperative complications
Time frame: 3 months
Describe the length of operative stay (for the initial reconstruction), for all patients and according to the methods of reconstruction performed
Time frame: 3 months
Describe the duration of drainage for all patients and according to the methods of reconstruction performed
Time frame: 3 months
Describe the number of surgery(s) required to obtain a good aesthetic result
Time frame: 3 months
Describe the number of consultations for seroma punctures, for all patients and according to the methods of reconstruction performed
Time frame: 3 months
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 Feb 2026.
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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.
Céline RENAUDEAU, MD principal investigator
celine.renaudeau@ico.unicancer.fr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female, run by Institut Cancerologie de l'Ouest 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 6 inclusion and 6 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 Feb 2026. 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?
Describe postoperative pain and functional results (time frame: 6 month). 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 Feb 2026.