Breast CancerNCT06119633
Implant-based Breast Reconstruction and Mastectomy With Fat Grafting After Breast Conserving Surgery and Radiotherapy
A study testing Immediate tissue expander and lipofilling after mastectomy in people with Breast Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 2 sites in Italy.
Trial summary
Higher rates of complications and poorer cosmetic outcomes have been reported after salvage mastectomy and implant-based versus autologous reconstruction in patients previously exposed to radiation therapy (i) on the breast as adjuvant treatment after breast conserving surgery (BCS) or (ii) on thoracic wall for… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Immediate tissue expander and lipofilling after mastectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 2 sitesItaly
- Study dates
- Jun 2007to Dec 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients candidate to mastectomy (salvage mastectomy for breast cancer recurrence or prophylactic mastectomy) who had been irradiated as adjuvant treatment after breast conserving surgery or as treatment for Hodgkin lymphoma
- signed informed consent to participate and to implant-based breast reconstruction
- absence of distant metastases or other malignancies.
Who cannot join
- presence of distant metastases or other malignancies.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Morgagni Pierantoni Hospital
Forlì, 47121
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
About this study
Official title: Immediate Tissue Expander and Lipofilling After Mastectomy for Breast Cancer Recurrence Following Lumpectomy and Irradiation: Retrospective Multicentric Clinical Trial
Higher rates of complications and poorer cosmetic outcomes have been reported after salvage mastectomy and implant-based versus autologous reconstruction in patients previously exposed to radiation therapy (i) on the breast as adjuvant treatment after breast conserving surgery (BCS) or (ii) on thoracic wall for Hodgkin Lymphoma (HL). Nevertheless, selected patients with favourable preoperative soft-tissue assessment may benefit from alloplastic reconstruction and fat grafting that has been suggested as an effective technique to promote the regeneration of irradiated tissues.
The aims of this study are to assess:
- the feasibility of implant-based breast reconstruction and fat grafting after mastectomy (simple mastectomy, nipple-sparing and skin-sparing mastectomy)
- oncological safety of implant-based breast reconstruction and fat grafting.
Read the detailed description
National Comprehensive Cancer Network guidelines recommend autologous reconstruction as the preferred breast reconstruction after mastectomy in previously irradiated patients because of higher complication rates and worse aesthetic outcomes as compared to immediate breast implant reconstruction. In fact, unacceptable rates of complications (60-70%) have been reported by first experiences. Instead, autologous reconstruction showed lower complication rates as compared to implant-based breast reconstruction (25.5% vs 50.9%). However, it may not be indicated in patients with previous surgery at the donor site or in case of other contraindications, requires longer surgical time and is at risk of donor-site morbidity and loss of sensation.
On the other hand, fat grafting improves softness of tissues and scars, releasing their rigidity and for these effects it has been studied for effectively promoting the regeneration of irradiated tissues, enlarging the envelope thickness for safety reasons, optimizing cosmetic outcomes and ultimately increasing patient comfort and quality of life.
Therefore, a surgical technique combining implant-based breast reconstruction after mastectomy and fat grafting may favor alloplastic reconstruction in selected patients.
The investigators enroll patients candidate to mastectomy and breast reconstruction who had received prior adjuvant radiation therapy after breast conserving surgery (BCS) or radiation therapy for the treatment of Hodgkin Lymphoma (HL).
Aims of the study are to investigate (i) the feasibility of implant-based breast reconstruction and fat grafting after mastectomy (simple mastectomy, nipple-sparing and skin-sparing mastectomy); (ii) the oncological safety of implant-based breast reconstruction and fat grafting.
- Conditions
- Breast Cancer
- Being tested
- Immediate tissue expander and lipofilling after mastectomy
- Keywords
- Breast cancer, Radiotherapy, Implant-based breast reconstruction, Fat grafting, Adipose tissue transplant, Lipofilling, Hodgkin lymphoma, Expander
- Medical subject headings
- Breast Neoplasms, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate tissue expander and lipofilling after mastectomyProcedure or surgery
Implant-based breast reconstruction and fat grafting after salvage or prophylactic mastectomy in patients previously exposed to radiation therapy on the breast as adjuvant treatment after breast conserving surgery (BCS) or on thoracic wall for Hodgkin Lymphoma (HL).
| Study group | Role | What they receive |
|---|---|---|
| Immediate tissue expander and fat grafting after mastectomy | Experimental | Patients underwent simple mastectomy, skin-sparing or nipple-sparing mastectomy and implant-based, two-stage breast reconstruction: contextual mastectomy and expander positioning were performed during first stage (stage I) while substitution of the expander with definitive implant occurred during second stage (stage II). Fat grafting with regenerative intent was performed during stage I or between stage I and II. Adipose tissue was harvested from the abdomen, flanks, trochanter regions, inner thigh and medial aspect of knees. Fat was injected in the subfascial plane of the pectoralis major muscle with blunt cannula in order to avoid thrombo-embolic risks. At least six months after stage I patients underwent expander substitution with definitive implant and contralateral mammoplasty when required. In case of complications that required removal of the implant, autologous reconstruction was performed. Receives: Procedure: Immediate tissue expander and lipofilling after mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rates after stage I and II
Identification of complication rates after stage I and II, measuring percentage of complications (pain and patient discomfort, partial necrosis of mastectomy flaps, nipple-areolar necrosis, delayed wound healing, capsular contracture, bleeding, expander or implant exposition, infection, expander rupture, re-operations, reconstruction failures) over the total number of surgical procedures of stage I and II.
Measured: 1 month, 6 months and 12 months
Patient's satisfaction
Self-assessed patient reports for identification of patient's satisfaction, measuring percentage of patients that were satisfied with results overall.
Measured: 12 months
Cosmetic outcomes
Clinical and photography-based assessments for cosmetic outcomes measurement graded by a plastic breast surgeon as excellent, very good, good, fair, or poor.
Measured: 1 month, 6 months and 12 months
Secondary outcomes (1)
Oncological safety of implant-based breast reconstruction and fat grafting.
Identification of rate of loco-regional and distant metastases.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study startJun 2007
- Primary completionDec 2023
- Study completionDec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe 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
- 163 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Morgagni Pierantoni Hospital
- Responsible party
- Sponsor
- Investigators
- Chiara Listorti, MD, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoSecondo Folli, MD, Study director, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119633
- Sponsor's protocol ID
- INT 217/23
- Status last verified
- Oct 2023
- First submitted
- 30 Oct 2023
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Krueger EA, Wilkins EG, Strawderman M, Cederna P, Goldfarb S, Vicini FA, Pierce LJ. Complications and patient satisfaction following expander/implant breast reconstruction with and without radiotherapy. Int J Radiat Oncol Biol Phys. 2001 Mar 1;49(3):713-21. doi: 10.1016/s0360-3016(00)01402-4.
PubMed 11172953Dickson MG, Sharpe DT, Dickson WA, Wilde GP, Brennan TG, Roberts AH. Breast reconstruction by tissue expansion. Ann R Coll Surg Engl. 1987 Jan;69(1):19-21.
PubMed 3566111Manyam BV, Shah C, Woody NM, Reddy CA, Weller MA, Juloori A, Naik M, Valente S, Grobmyer S, Durand P, Djohan R, Tendulkar RD. Long-Term Outcomes After Autologous or Tissue Expander/Implant-Based Breast Reconstruction and Postmastectomy Radiation for Breast Cancer. Pract Radiat Oncol. 2019 Nov;9(6):e497-e505. doi: 10.1016/j.prro.2019.06.008. Epub 2019 Jun 22.
PubMed 31238166Khansa I, Boehmler JH 4th. Aesthetic outcomes in women undergoing breast-conserving therapy followed by mastectomy and microsurgical reconstruction. Microsurgery. 2015 Jan;35(1):21-8. doi: 10.1002/micr.22225. Epub 2014 Jan 21.
PubMed 24449018Debald M, Pech T, Kaiser C, Keyver-Paik MD, Walgenbach-Bruenagel G, Kalff JC, Kuhn W, Walgenbach KJ. Lipofilling effects after breast cancer surgery in post-radiation patients: an analysis of results and algorithm proposal. Eur J Plast Surg. 2017;40(5):447-454. doi: 10.1007/s00238-017-1311-1. Epub 2017 May 29.
PubMed 28989237Salgarello M, Visconti G, Barone-Adesi L. Fat grafting and breast reconstruction with implant: another option for irradiated breast cancer patients. Plast Reconstr Surg. 2012 Feb;129(2):317-329. doi: 10.1097/PRS.0b013e31822b6619.
PubMed 21987041Coleman SR, Saboeiro AP. Fat grafting to the breast revisited: safety and efficacy. Plast Reconstr Surg. 2007 Mar;119(3):775-85; discussion 786-7. doi: 10.1097/01.prs.0000252001.59162.c9.
PubMed 17312477
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Tissue Expander and Lipofilling After Mastectomy for Breast Cancer Recurrence Following Lumpectomy and Irradiation: Retrospective Multicentric Clinical Trial
- ClinicalTrials.gov ID
- NCT06119633
- Acronym / sponsor ID
- INT 217/23
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Radiotherapy, Implant-based breast reconstruction, Fat grafting, Adipose tissue transplant, Lipofilling, Hodgkin lymphoma, Expander
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Collaborators
- Morgagni Pierantoni Hospital
- Study start
- Jun 2007 (actual)
- Primary completion
- Dec 2023 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 7 Nov 2023 (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.
Higher rates of complications and poorer cosmetic outcomes have been reported after salvage mastectomy and implant-based versus autologous reconstruction in patients previously exposed to radiation therapy (i) on the breast as adjuvant treatment after breast conserving surgery (BCS) or (ii) on thoracic wall for Hodgkin Lymphoma (HL). Nevertheless, selected patients with favourable preoperative soft-tissue assessment may benefit from alloplastic reconstruction and fat grafting that has been suggested as an effective technique to promote the regeneration of irradiated tissues.
The aims of this study are to assess:
- the feasibility of implant-based breast reconstruction and fat grafting after mastectomy (simple mastectomy, nipple-sparing and skin-sparing mastectomy)
- oncological safety of implant-based breast reconstruction and fat grafting.
Detailed description
National Comprehensive Cancer Network guidelines recommend autologous reconstruction as the preferred breast reconstruction after mastectomy in previously irradiated patients because of higher complication rates and worse aesthetic outcomes as compared to immediate breast implant reconstruction. In fact, unacceptable rates of complications (60-70%) have been reported by first experiences. Instead, autologous reconstruction showed lower complication rates as compared to implant-based breast reconstruction (25.5% vs 50.9%). However, it may not be indicated in patients with previous surgery at the donor site or in case of other contraindications, requires longer surgical time and is at risk of donor-site morbidity and loss of sensation.
On the other hand, fat grafting improves softness of tissues and scars, releasing their rigidity and for these effects it has been studied for effectively promoting the regeneration of irradiated tissues, enlarging the envelope thickness for safety reasons, optimizing cosmetic outcomes and ultimately increasing patient comfort and quality of life.
Therefore, a surgical technique combining implant-based breast reconstruction after mastectomy and fat grafting may favor alloplastic reconstruction in selected patients.
The investigators enroll patients candidate to mastectomy and breast reconstruction who had received prior adjuvant radiation therapy after breast conserving surgery (BCS) or radiation therapy for the treatment of Hodgkin Lymphoma (HL).
Aims of the study are to investigate (i) the feasibility of implant-based breast reconstruction and fat grafting after mastectomy (simple mastectomy, nipple-sparing and skin-sparing mastectomy); (ii) the oncological safety of implant-based breast reconstruction and fat grafting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immediate tissue expander and fat grafting after mastectomy | Experimental | Procedure: Immediate tissue expander and lipofilling after mastectomyPatients underwent simple mastectomy, skin-sparing or nipple-sparing mastectomy and implant-based, two-stage breast reconstruction: contextual mastectomy and expander positioning were performed during first stage (stage I) while substitution of the expander with definitive implant occurred during second stage (stage II). Fat grafting with regenerative intent was performed during stage I or between stage I and II. Adipose tissue was harvested from the abdomen, flanks, trochanter regions, inner thigh and medial aspect of knees. Fat was injected in the subfascial plane of the pectoralis major muscle with blunt cannula in order to avoid thrombo-embolic risks. At least six months after stage I patients underwent expander substitution with definitive implant and contralateral mammoplasty when required. In case of complications that required removal of the implant, autologous reconstruction was performed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients candidate to mastectomy (salvage mastectomy for breast cancer recurrence or prophylactic mastectomy) who had been irradiated as adjuvant treatment after breast conserving surgery or as treatment for Hodgkin lymphoma
- signed informed consent to participate and to implant-based breast reconstruction
- absence of distant metastases or other malignancies.
Key exclusion criteria (1 listed)
- presence of distant metastases or other malignancies.
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 tissue expander and lipofilling after mastectomyImplant-based breast reconstruction and fat grafting after salvage or prophylactic mastectomy in patients previously exposed to radiation therapy on the breast as adjuvant treatment after breast conserving surgery (BCS) or on thoracic wall for Hodgkin Lymphoma (HL). | Procedure or surgery | Immediate tissue expander and fat grafting after mastectomy |
Primary outcome
Complication rates after stage I and II
Time frame: 1 month, 6 months and 12 months
Identification of complication rates after stage I and II, measuring percentage of complications (pain and patient discomfort, partial necrosis of mastectomy flaps, nipple-areolar necrosis, delayed wound healing, capsular contracture, bleeding, expander or implant exposition, infection, expander rupture, re-operations, reconstruction failures) over the total number of surgical procedures of stage I and II.
Patient's satisfaction
Time frame: 12 months
Self-assessed patient reports for identification of patient's satisfaction, measuring percentage of patients that were satisfied with results overall.
Cosmetic outcomes
Time frame: 1 month, 6 months and 12 months
Clinical and photography-based assessments for cosmetic outcomes measurement graded by a plastic breast surgeon as excellent, very good, good, fair, or poor.
1 secondary outcome
Oncological safety of implant-based breast reconstruction and fat grafting.
Time frame: 5 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 8 Mar 2024.
- Results publication: PubMed 11172953Krueger EA, Wilkins EG, Strawderman M, Cederna P, Goldfarb S, Vicini FA, Pierce LJ. Complications and patient satisfaction following expander/implant breast reconstruction with and without radiotherapy. Int J Radiat Oncol Biol Phys. 2001 Mar 1;49(3):713-21. doi: 10.1016/s0360-3016(00)01402-4.
- Results publication: PubMed 3566111Dickson MG, Sharpe DT, Dickson WA, Wilde GP, Brennan TG, Roberts AH. Breast reconstruction by tissue expansion. Ann R Coll Surg Engl. 1987 Jan;69(1):19-21.
- Results publication: PubMed 31238166Manyam BV, Shah C, Woody NM, Reddy CA, Weller MA, Juloori A, Naik M, Valente S, Grobmyer S, Durand P, Djohan R, Tendulkar RD. Long-Term Outcomes After Autologous or Tissue Expander/Implant-Based Breast Reconstruction and Postmastectomy Radiation for Breast Cancer. Pract Radiat Oncol. 2019 Nov;9(6):e497-e505. doi: 10.1016/j.prro.2019.06.008. Epub 2019 Jun 22.
- Results publication: PubMed 24449018Khansa I, Boehmler JH 4th. Aesthetic outcomes in women undergoing breast-conserving therapy followed by mastectomy and microsurgical reconstruction. Microsurgery. 2015 Jan;35(1):21-8. doi: 10.1002/micr.22225. Epub 2014 Jan 21.
- Results publication: PubMed 28989237Debald M, Pech T, Kaiser C, Keyver-Paik MD, Walgenbach-Bruenagel G, Kalff JC, Kuhn W, Walgenbach KJ. Lipofilling effects after breast cancer surgery in post-radiation patients: an analysis of results and algorithm proposal. Eur J Plast Surg. 2017;40(5):447-454. doi: 10.1007/s00238-017-1311-1. Epub 2017 May 29.
- Results publication: PubMed 21987041Salgarello M, Visconti G, Barone-Adesi L. Fat grafting and breast reconstruction with implant: another option for irradiated breast cancer patients. Plast Reconstr Surg. 2012 Feb;129(2):317-329. doi: 10.1097/PRS.0b013e31822b6619.
- Results publication: PubMed 17312477Coleman SR, Saboeiro AP. Fat grafting to the breast revisited: safety and efficacy. Plast Reconstr Surg. 2007 Mar;119(3):775-85; discussion 786-7. doi: 10.1097/01.prs.0000252001.59162.c9.
- last day of access July 26th 2023Link provided by the sponsor.
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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.
Chiara Listorti, MD principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Secondo Folli, MD study director
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate tissue expander and lipofilling after mastectomy in people with Breast Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 2 sites 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 3 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 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Complication rates after stage I and II (time frame: 1 month, 6 months and 12 months). The study lists 3 primary outcomes in all. 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 NCT06119633, which also lists 7 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 8 Mar 2024.