Implant-based Breast Reconstruction and Mastectomy With Fat Grafting After Breast Conserving Surgery and Radiotherapy

Breast Cancer Clinical Trial

Official title:

Immediate Tissue Expander and Lipofilling After Mastectomy for Breast Cancer Recurrence Following Lumpectomy and Irradiation: Retrospective Multicentric Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06119633
• Other study ID #: INT 217/23
• Status: Completed
• Phase: N/A
• Start date: June 2007
• Est. completion date: December 2023

Study information

• Verified date: October 2023
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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: 1. the feasibility of implant-based breast reconstruction and fat grafting after mastectomy (simple mastectomy, nipple-sparing and skin-sparing mastectomy) 2. oncological safety of implant-based breast reconstruction and fat grafting.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• presence of distant metastases or other malignancies.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Immediate tissue expander and lipofilling after mastectomy
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).

Locations

Country	Name	City	State
Italy	Morgagni Pierantoni Hospital	Forlì
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milan

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano	Morgagni Pierantoni Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (7)

Coleman 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. — View Citation

Debald 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):44 — View Citation

Dickson 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. — View Citation

Khansa 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. — View Citation

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):713-2 — View Citation

Manyam 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 Breas — View Citation

Salgarello 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month, 6 months and 12 months
Primary	Patient's satisfaction	Self-assessed patient reports for identification of patient's satisfaction, measuring percentage of patients that were satisfied with results overall.	12 months
Primary	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.	1 month, 6 months and 12 months
Secondary	Oncological safety of implant-based breast reconstruction and fat grafting.	Identification of rate of loco-regional and distant metastases.	5 years

External Links

•   last day of access July 26th 2023