MammaplastyNCT04854525

Breast Reconstruction in Previously Irradiated Breast

An observational study of Mammaplasty and Radiotherapy; Complications, run by Humanitas Clinical and Research Center at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

For patients with breast cancer subject to a mastectomy, preserving the morphology of the breast with immediate reconstruction is a crucial aspect to preserve the quality of life. There are several types of breast reconstruction: prosthetic in one or two stages and autologous reconstruction. Read more about this study

Who is it for?: Ages 18 to 80 years, women only
Conditions the study is for: Mammaplasty, Radiotherapy; Complications, Breast Implant; Complications
What is being tested?: Pre reconstruction Radiotherapy
Type of treatment: Surgery or procedure
How many people: 2,150 participants
Where: 1 siteItaly
Study dates: 6 Jun 2020to 25 Jan 2021
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 to 80 years
Women only
No healthy volunteers
Adult, Older adult

Study population: Patients of some Breast Units in Italy

Who may be able to join

Patients subjected to mastectomy and immediate reconstruction directly with prostheses, in two times and by autologue flaps (TRAM, Latissimus Dorsi Flap, DIEP and any other method)

Who cannot join

Delayed prosthetic reconstruction

Trial locations and contacts

1 site in 1 country.

Italy1 site

Istituto Clinico Humanitas
Rozzano, Milan, 20089

Other trials in Italy

About this study

Official title: Multicenter Retrospective Evaluation Study of Pre-reconstruction Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction

For patients with breast cancer subject to a mastectomy, preserving the morphology of the breast with immediate reconstruction is a crucial aspect to preserve the quality of life.

There are several types of breast reconstruction: prosthetic in one or two stages and autologous reconstruction.

Adjuvant radiotherapy has shown an improvement of the overall survival and of the local control for patients with positive lymph nodes. As a consequence, plastic surgeons come into contact with more patients with a history of irradiation of their breasts than ever before.

However, there are few studies with a significant number that evaluate the effect of pre-reconstruction radiotherapy on the three types of reconstruction.

The aim of this study is to compare retrospectively these three types of reconstruction techniques to evaluate the impact of breast prior irradiation on the outcome of prosthetic reconstruction.

Conditions: Mammaplasty, Radiotherapy; Complications, Breast Implant; Complications, Transplant Failure
Being tested: Pre reconstruction Radiotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pre reconstruction RadiotherapyRadiation
Previous PMRT

Study groups in NCT04854525
Study group	Role	What they receive
One Stage Reconstruction With pre-reconstruction Radiotherapy		Not described Receives: Radiation: Pre reconstruction Radiotherapy
Two Stage Reconstruction With pre-reconstruction Radiotherapy		Not described Receives: Radiation: Pre reconstruction Radiotherapy
Autologous Reconstruction With pre-reconstruction Radiotherapy		Not described Receives: Radiation: Pre reconstruction Radiotherapy
One Stage Reconstruction Without pre-reconstruction Radiotherapy		Not described
Two Stage Reconstruction Without pre-reconstruction Radiotherapy		Not described
Autologous Reconstruction Without pre-reconstruction Radiotherapy		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Reconstruction failure
Complication rate (as hematoma, seroma, prosthetic exposure, skin and fat necrosis) that resulted in explant (prosthetic, expander or flap)
Measured: 2 years

Secondary outcomes (1)

Reconstruction Complications
Rate of need for reintervention
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jun 202025 Jan 2021

First posted22 Apr 2021
Study start6 Jun 2020
Primary completion23 Nov 2020
Study completion25 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for MammaplastyStudies 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: Case-control
Time perspective: Retrospective
Enrolment: 2,150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04854525
Sponsor's protocol ID: 49/20 b
Status last verified: Apr 2021
First submitted: 24 Mar 2021
Last updated: 22 Apr 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Al-Ghazal SK, Fallowfield L, Blamey RW. Comparison of psychological aspects and patient satisfaction following breast conserving surgery, simple mastectomy and breast reconstruction. Eur J Cancer. 2000 Oct;36(15):1938-43. doi: 10.1016/s0959-8049(00)00197-0.
PubMed 11000574
Cordeiro PG. Breast reconstruction after surgery for breast cancer. N Engl J Med. 2008 Oct 9;359(15):1590-601. doi: 10.1056/NEJMct0802899. No abstract available.
PubMed 18843123
Recht A, Comen EA, Fine RE, Fleming GF, Hardenbergh PH, Ho AY, Hudis CA, Hwang ES, Kirshner JJ, Morrow M, Salerno KE, Sledge GW Jr, Solin LJ, Spears PA, Whelan TJ, Somerfield MR, Edge SB. Postmastectomy Radiotherapy: An American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Focused Guideline Update. Pract Radiat Oncol. 2016 Nov-Dec;6(6):e219-e234. doi: 10.1016/j.prro.2016.08.009. Epub 2016 Sep 19.
PubMed 27659727
Yanko-Arzi R, Cohen MJ, Braunstein R, Kaliner E, Neuman R, Brezis M. Breast reconstruction: complication rate and tissue expander type. Aesthetic Plast Surg. 2009 Jul;33(4):489-96. doi: 10.1007/s00266-008-9192-0. Epub 2008 Jun 6.
PubMed 18535851
Christante D, Pommier SJ, Diggs BS, Samuelson BT, Truong A, Marquez C, Hansen J, Naik AM, Vetto JT, Pommier RF. Using complications associated with postmastectomy radiation and immediate breast reconstruction to improve surgical decision making. Arch Surg. 2010 Sep;145(9):873-8. doi: 10.1001/archsurg.2010.170.
PubMed 20855758
Berry T, Brooks S, Sydow N, Djohan R, Nutter B, Lyons J, Dietz J. Complication rates of radiation on tissue expander and autologous tissue breast reconstruction. Ann Surg Oncol. 2010 Oct;17 Suppl 3:202-10. doi: 10.1245/s10434-010-1261-3. Epub 2010 Sep 19.
PubMed 20853034
Chang DW, Barnea Y, Robb GL. Effects of an autologous flap combined with an implant for breast reconstruction: an evaluation of 1000 consecutive reconstructions of previously irradiated breasts. Plast Reconstr Surg. 2008 Aug;122(2):356-362. doi: 10.1097/PRS.0b013e31817d6303.
PubMed 18626350
Ascherman JA, Hanasono MM, Newman MI, Hughes DB. Implant reconstruction in breast cancer patients treated with radiation therapy. Plast Reconstr Surg. 2006 Feb;117(2):359-65. doi: 10.1097/01.prs.0000201478.64877.87.
PubMed 16462313
Nahabedian MY, Tsangaris T, Momen B, Manson PN. Infectious complications following breast reconstruction with expanders and implants. Plast Reconstr Surg. 2003 Aug;112(2):467-76. doi: 10.1097/01.PRS.0000070727.02992.54.
PubMed 12900604
Caviggioli F, Maione L, Klinger F, Lisa A, Klinger M. Autologous Fat Grafting Reduces Pain in Irradiated Breast: A Review of Our Experience. Stem Cells Int. 2016;2016:2527349. doi: 10.1155/2016/2527349. Epub 2015 Dec 29.
PubMed 26858758

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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ChatGPT & Surgeon Synergy: Redefining Breast Reconstruction Consultations for Enhanced Patient Engagement and Satisfaction
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The Study is an Observational Post-market Follow-up Program to Evaluate Long Term (5 Years) Safety of Mentor Breast Implants in Chinese Population
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Active, not recruiting
Memory Gel and Shape Combined Cohort
Primary Breast Augmentation, Primary Breast Reconstruction
Active, not recruiting
A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction
Breast Reconstruction, Revision Breast Reconstruction
Not yet recruiting
Impact of Intraoperative Neurotization on Sensory Recovery of the Nipple and Breast Skin in Patients Undergoing Nipple Sparing Mastectomy With Immediate Implant-Based Reconstruction: NERSENSE, Prospective Randomized Control Study
Breast Cancer

All Mammaplasty trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter Retrospective Evaluation Study of Pre-reconstruction Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction
ClinicalTrials.gov ID: NCT04854525
Acronym / sponsor ID: 49/20 b
Conditions: Mammaplasty, Radiotherapy; Complications, Breast Implant; Complications, Transplant Failure
Study type: Observational
Recruitment status: Completed
Enrolment: 2,150 participants (actual)
Lead sponsor: Humanitas Clinical and Research CenterUniversity, hospital or other
Collaborators: Marco Klinger, Marta Scorsetti, Davide Franceschini, Emanuela Morenghi
Study start: 6 Jun 2020 (actual)
Primary completion: 23 Nov 2020 (actual)
Study completion: 25 Jan 2021 (actual)
First posted: 22 Apr 2021 (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.

For patients with breast cancer subject to a mastectomy, preserving the morphology of the breast with immediate reconstruction is a crucial aspect to preserve the quality of life.

There are several types of breast reconstruction: prosthetic in one or two stages and autologous reconstruction.

However, there are few studies with a significant number that evaluate the effect of pre-reconstruction radiotherapy on the three types of reconstruction.

The aim of this study is to compare retrospectively these three types of reconstruction techniques to evaluate the impact of breast prior irradiation on the outcome of prosthetic reconstruction.

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 6

Arm	Type	Receives
One Stage Reconstruction With pre-reconstruction Radiotherapy	–	Radiation: Pre reconstruction Radiotherapy
Two Stage Reconstruction With pre-reconstruction Radiotherapy	–	Radiation: Pre reconstruction Radiotherapy
Autologous Reconstruction With pre-reconstruction Radiotherapy	–	Radiation: Pre reconstruction Radiotherapy
One Stage Reconstruction Without pre-reconstruction Radiotherapy	–	–
Two Stage Reconstruction Without pre-reconstruction Radiotherapy	–	–
Autologous Reconstruction Without pre-reconstruction Radiotherapy	–	–

Who may qualify

Ages: 18 to 80 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients of some Breast Units in Italy

Key inclusion criteria (1 listed)

Patients subjected to mastectomy and immediate reconstruction directly with prostheses, in two times and by autologue flaps (TRAM, Latissimus Dorsi Flap, DIEP and any other method)

Key exclusion criteria (1 listed)

Delayed prosthetic 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
Pre reconstruction RadiotherapyPrevious PMRT	Radiation	Autologous Reconstruction With pre-reconstruction Radiotherapy, One Stage Reconstruction With pre-reconstruction Radiotherapy, Two Stage Reconstruction With pre-reconstruction Radiotherapy

Primary outcome

Reconstruction failure
Time frame: 2 years
Complication rate (as hematoma, seroma, prosthetic exposure, skin and fat necrosis) that resulted in explant (prosthetic, expander or flap)

1 secondary outcome

Reconstruction Complications
Time frame: 2 years

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 22 Apr 2021.
Background: PubMed 11000574Al-Ghazal SK, Fallowfield L, Blamey RW. Comparison of psychological aspects and patient satisfaction following breast conserving surgery, simple mastectomy and breast reconstruction. Eur J Cancer. 2000 Oct;36(15):1938-43. doi: 10.1016/s0959-8049(00)00197-0.
Background: PubMed 18843123Cordeiro PG. Breast reconstruction after surgery for breast cancer. N Engl J Med. 2008 Oct 9;359(15):1590-601. doi: 10.1056/NEJMct0802899. No abstract available.
Background: PubMed 27659727Recht A, Comen EA, Fine RE, Fleming GF, Hardenbergh PH, Ho AY, Hudis CA, Hwang ES, Kirshner JJ, Morrow M, Salerno KE, Sledge GW Jr, Solin LJ, Spears PA, Whelan TJ, Somerfield MR, Edge SB. Postmastectomy Radiotherapy: An American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Focused Guideline Update. Pract Radiat Oncol. 2016 Nov-Dec;6(6):e219-e234. doi: 10.1016/j.prro.2016.08.009. Epub 2016 Sep 19.
Background: PubMed 18535851Yanko-Arzi R, Cohen MJ, Braunstein R, Kaliner E, Neuman R, Brezis M. Breast reconstruction: complication rate and tissue expander type. Aesthetic Plast Surg. 2009 Jul;33(4):489-96. doi: 10.1007/s00266-008-9192-0. Epub 2008 Jun 6.
Background: PubMed 20855758Christante D, Pommier SJ, Diggs BS, Samuelson BT, Truong A, Marquez C, Hansen J, Naik AM, Vetto JT, Pommier RF. Using complications associated with postmastectomy radiation and immediate breast reconstruction to improve surgical decision making. Arch Surg. 2010 Sep;145(9):873-8. doi: 10.1001/archsurg.2010.170.
Background: PubMed 20853034Berry T, Brooks S, Sydow N, Djohan R, Nutter B, Lyons J, Dietz J. Complication rates of radiation on tissue expander and autologous tissue breast reconstruction. Ann Surg Oncol. 2010 Oct;17 Suppl 3:202-10. doi: 10.1245/s10434-010-1261-3. Epub 2010 Sep 19.
Background: PubMed 18626350Chang DW, Barnea Y, Robb GL. Effects of an autologous flap combined with an implant for breast reconstruction: an evaluation of 1000 consecutive reconstructions of previously irradiated breasts. Plast Reconstr Surg. 2008 Aug;122(2):356-362. doi: 10.1097/PRS.0b013e31817d6303.
Background: PubMed 16462313Ascherman JA, Hanasono MM, Newman MI, Hughes DB. Implant reconstruction in breast cancer patients treated with radiation therapy. Plast Reconstr Surg. 2006 Feb;117(2):359-65. doi: 10.1097/01.prs.0000201478.64877.87.
Background: PubMed 12900604Nahabedian MY, Tsangaris T, Momen B, Manson PN. Infectious complications following breast reconstruction with expanders and implants. Plast Reconstr Surg. 2003 Aug;112(2):467-76. doi: 10.1097/01.PRS.0000070727.02992.54.
Background: PubMed 26858758Caviggioli F, Maione L, Klinger F, Lisa A, Klinger M. Autologous Fat Grafting Reduces Pain in Irradiated Breast: A Review of Our Experience. Stem Cells Int. 2016;2016:2527349. doi: 10.1155/2016/2527349. Epub 2015 Dec 29.
Individual participant dataSharing planned: No

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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.

Marco Klinger study director

Humanitas Hospital, Italy

Davide Franceschini study chair

Humanitas Hospital, Italy

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 Mammaplasty and Radiotherapy; Complications, run by Humanitas Clinical and Research Center at 1 site in Italy.

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 1 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 22 Apr 2021. 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 Italy. 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?

Reconstruction failure (time frame: 2 years). 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 NCT04854525, which also lists 10 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 22 Apr 2021.