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

NCT06119633 | Completed DMC

• 1 other identifier: INT 217/23
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 2

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

Conditions

Breast Cancer

Keywords

Breast cancer; Radiotherapy; Implant-based breast reconstruction; Fat grafting; Adipose tissue transplant; Lipofilling; Hodgkin lymphoma; Expander

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Oncological safety of implant-based breast reconstruction and fat grafting.

  5 years

Study Arms (1)

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.

Procedure: Immediate tissue expander and lipofilling after mastectomy

Interventions

Immediate tissue expander and lipofilling after mastectomy PROCEDURE

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).

Immediate tissue expander and fat grafting after mastectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- presence of distant metastases or other malignancies.

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead
• Morgagni Pierantoni Hospital: collaborator

Study Sites (2)

Morgagni Pierantoni Hospital

Forlì, 47121, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

Location

Related Publications (7)

• 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.

  PMID: 11172953 RESULT

• 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.

  PMID: 3566111 RESULT

• 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 Breast Cancer. Pract Radiat Oncol. 2019 Nov;9(6):e497-e505. doi: 10.1016/j.prro.2019.06.008. Epub 2019 Jun 22.

  PMID: 31238166 RESULT

• 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.

  PMID: 24449018 RESULT

• 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):447-454. doi: 10.1007/s00238-017-1311-1. Epub 2017 May 29.

  PMID: 28989237 RESULT

• 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.

  PMID: 21987041 RESULT

• 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.

  PMID: 17312477 RESULT

Related Links

• last day of access July 26th 2023

MeSH Terms

Conditions

Breast Neoplasms; Hodgkin Disease

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Chiara Listorti, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

  PRINCIPAL INVESTIGATOR

• Secondo Folli, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 7, 2023
• Study Start: June 1, 2007
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 8, 2024

Record last verified: 2023-10

Locations

IT (2)