Immediate Breast Reconstruction Following Mastectomy (IRMA)

Breast Cancer Female Clinical Trial

— IRMA  

Official title:

A Multicenter, Observational Cohort Study of Women Undergoing Immediate Breast Reconstruction Following MAstectomy (IRMA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04390529
• Other study ID #: IRMA
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: June 30, 2026

Study information

• Verified date: June 2023
• Source: Thurgau Breast Center
• Contact: Mathias Fehr, Prof. Dr.
• Phone: 0041 52 723 72 55
• Email: mathias.fehr[@]stgag.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Based on data from the US Surveillance, Epidemiology and End Result Program (SEER), the rates of nipple-sparing mastectomy (NSM) have risen 202% since 2009. In spite of the increasing popularity of IRMA, limited research has been done to identify complications in patients undergoing these procedures. Of particular importance is to assess the effects of combining the procedure with radiotherapy, and undergoing a one- versus two-step surgical procedure.

Active monitoring and periodic assessment of IRMA patients are needed to establish the safety of these different techniques in terms of complications and recurrence rates. Identifying an optimal strategy for IRMA may lead to the development of clinical guidelines, which are currently lacking.

Description:

This is a multicenter observational, cohort study. The study is designed to serve a similar purpose as a disease registry. The only study-specific intervention will be the completion of the BREAST-Q quality-of-life (QoL) form. Only quantitative data will be collected. The rationale for this study design is to identify and describe the type and frequency of complications related to IRMA. No hypothesis is being tested. Although group comparisons based on surgical techniques will be made, conclusions based on these findings will be limited by the observational nature of the design.

Data from patients will be collected using a series of pseudonymized case report forms, including the validated quality-of-life questionnaire: BREAST-Q. These data will be entered into the web-based data collection system, SecuTrial. A precise description of the surgical procedure will be required, as specified on the case report forms (e.g., implantation of a mesh, resection margins), to allow for subsequent multivariate analyses.

During the first year of follow-up, data from routine clinical assessments and the QoL forms will be gathered at baseline (within 90 days after mastectomy), 6 and 12 months. Thereafter, data will be collected from annual clinical assessments and completion of the QoL form will be done for an additional four years (24, 36, 48 and 60 months postoperatively). Consequently, a total of five years of postoperative follow-up data will be collected to allow sufficient time for the development of the majority of foreseeable complications.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 455
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any women = 18 years of age undergoing IRMA (NSM or SSM) at any participating breast center may be included in the study.

• Women undergoing IRMA for either prophylactic or oncologic purposes

• Enrolment is possible up to 90 days after mastectomy

• A patient who has had the mastectomy at a non-participating institution, but has subsequently sought treatment at one of the study centers, may be eligible for enrolment up to 90 days following mastectomy

Exclusion Criteria:

• Unwillingness to have follow-up assessments at the participating breast centers

• Limited ability to understand study-specific procedures, which includes language difficulties.

Related Conditions & MeSH terms

• Breast Cancer Female

Intervention

Other:
• quality-of-life questionnaire: BREAST-Q
quality-of-life questionnaire: BREAST-Q

Locations

Country	Name	City	State
Switzerland	Kantonsspital Aarau AG	Aarau	Aargau
Switzerland	Kantonsspital Baden, Prof. Dr. med. Cornelia Leo	Baden	Aargau
Switzerland	Ospedale Regionale Bellinzona e Valli, Dr. Begoña Lipp von Wattenwyl	Bellinzona	Ticino
Switzerland	Brustzentrum Bern Biel, Hirslanden	Bern	BE
Switzerland	Campus SLB Sonnenhof AG	Bern
Switzerland	Centre du Sein de Genève - Hirslanden Clinique des Grangettes	Chêne-Bougeries	GE
Switzerland	Brustzentrum Thurgau, Spital Thurgau AG, Prof. Dr. med. Mathias K. Fehr	Frauenfeld	Thurgau
Switzerland	HUG - Hôpitaux universitaires de Genève	Genève
Switzerland	Brustzentrum Ostschweiz	St. Gallen	SG
Switzerland	Tumor- und BrustZentrum Ostschweiz	St. Gallen	Saint Gallen
Switzerland	Tumor- und Brustzentrum ZeTuP	St. Gallen	Saint Gallen
Switzerland	Spital Wetzikon	Wetzikon	ZH
Switzerland	Brust Centrum Zürich, Bethanien & Zollikerberg	Zollikerberg	ZH
Switzerland	Stadtspital Triemli	Zürich	ZH
Switzerland	Universitätsspital Zürich, Klinik für Gynäkologie	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Thurgau Breast Center

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of nipple-areola complex (NAC) or skin flap necrosis requiring specific treatment/surgery	Postoperative follow-up assessments include the documentation of nipple-areola complex (NAC) or skin flap necrosis	Three years after surgery
Primary	Rate of infection requiring surgery	Postoperative follow-up assessments include the documentation of infections requiring surgery	Three years after surgery
Primary	Grade of surgical complications	Postoperative follow-up assessments include the documentation of surgical complications (grading according to Clavien-Dindo Classification of Surgical Complications)	Three years after surgery
Secondary	Rate of minor complications not requiring surgery	Postoperative follow-up assessments include the documentation of skin necrosis outside NAC, wound dehiscence, and seroma requiring drainage	Three years after surgery
Secondary	Level of patient satisfaction with cosmesis	Postoperative follow-up assessment using BREAST-Q quality-of-life questionnaire that measures patient satisfaction with cosmetic outcome	Five years after surgery
Secondary	Level of sensitivity of the operated breast (NAC) compared to the non-operated breast	Postoperative follow-up assessments of breast functional outcomes	Five years after surgery
Secondary	Rate of breast cancer recurrence	Postoperative follow-up assessments include the documentation of recurrence in the NAC, skin flap outside the NAC, chest wall, locoregional lymph node (axillary, supraclavicular), distant metastasis	Five years after surgery