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Immediate Breast Reconstruction Following Mastectomy (IRMA) (IRMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04390529
Recruitment Status : Recruiting
First Posted : May 15, 2020
Last Update Posted : November 3, 2022
Sponsor:
Information provided by (Responsible Party):
Thurgau Breast Center

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Breast Cancer Female Other: quality-of-life questionnaire: BREAST-Q

Detailed 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 360 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter, Observational Cohort Study of Women Undergoing Immediate Breast Reconstruction Following MAstectomy (IRMA)
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : June 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Groups and Cohorts
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Intervention Details:
  • Other: quality-of-life questionnaire: BREAST-Q
    quality-of-life questionnaire: BREAST-Q

Outcome Measures
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Primary Outcome Measures :
  1. Rate of nipple-areola complex (NAC) or skin flap necrosis requiring specific treatment/surgery [ Time Frame: Three years after surgery ]
    Postoperative follow-up assessments include the documentation of nipple-areola complex (NAC) or skin flap necrosis

  2. Rate of infection requiring surgery [ Time Frame: Three years after surgery ]
    Postoperative follow-up assessments include the documentation of infections requiring surgery

  3. Grade of surgical complications [ Time Frame: Three years after surgery ]
    Postoperative follow-up assessments include the documentation of surgical complications (grading according to Clavien-Dindo Classification of Surgical Complications)


Secondary Outcome Measures :
  1. Rate of minor complications not requiring surgery [ Time Frame: Three years after surgery ]
    Postoperative follow-up assessments include the documentation of skin necrosis outside NAC, wound dehiscence, and seroma requiring drainage

  2. Level of patient satisfaction with cosmesis [ Time Frame: Five years after surgery ]
    Postoperative follow-up assessment using BREAST-Q quality-of-life questionnaire that measures patient satisfaction with cosmetic outcome

  3. Level of sensitivity of the operated breast (NAC) compared to the non-operated breast [ Time Frame: Five years after surgery ]
    Postoperative follow-up assessments of breast functional outcomes

  4. Rate of breast cancer recurrence [ Time Frame: Five years after surgery ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Breast cancer
Sampling Method:   Non-Probability Sample
Study Population
Women undergoing IRMA (NSM: nipple-areola sparing mastectomy or SSM: skin-sparing mastectomy) at any participating breast center may be included in the study. Patients undergoing IRMA for either prophylactic or oncologic purposes are eligible.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04390529


Contacts
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Contact: Mathias Fehr, Prof. Dr. 0041 52 723 72 55 mathias.fehr@stgag.ch
Contact: JoEllen Welter, MPH 0041 52 723 72 56 joellen.welter@stgag.ch

Locations
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Switzerland
Kantonsspital Baden, PD Dr. med. Cornelia Leo Recruiting
Baden, Aargau, Switzerland, 5404
Contact: Christin Kiesewetter    0041 56 486 36 36    Gynstudien@ksb.ch   
Brustzentrum Bern Biel, Hirslanden Recruiting
Bern, BE, Switzerland, 3013
Contact: Patrizia Sager, Dr.       Patrizia.Sager@hirslanden.ch   
Contact: Silvia Andrist    0041 31 337 89 69    Silvia.Andrist@hirslanden.ch   
Centre du Sein de Genève - Hirslanden Clinique des Grangettes Recruiting
Chêne-Bougeries, GE, Switzerland, 1224
Contact: Anne-Patricia Brunelli Roche, Dr.       patricia.brunelli@bluewin.ch   
Contact: Ashley Machen    0041 22 545 28 73    ashley.machen@grangettes.ch   
Tumor- und Brustzentrum ZeTuP, Dr. Véronique Dupont Lampert Recruiting
St. Gallen, Saint Gallen, Switzerland, 9006
Contact: Nicolette Hoefnagels, MSc    0041 71 243 0227    nicolette.hoefnagels@zetup.ch   
Brustzentrum Ostschweiz Recruiting
St. Gallen, SG, Switzerland, 9016
Contact: Rahel Hiltebrand, Dr.    0041 71 552 33 33    rahel.hiltebrand@bz-ost.ch   
Contact: Claudia Frey       Claudia.Frey@bz-ost.ch   
Kantonsspital Frauenfeld, Prof. Dr. med. Mathias K. Fehr Recruiting
Frauenfeld, Thurgau, Switzerland, 8500
Contact: JoEllen Welter, MPH    0041 52 723 72 56    joellen.welter@stgag.ch   
Ospedale Regionale Bellinzona e Valli, Dr. Begoña Lipp von Wattenwyl Recruiting
Bellinzona, Ticino, Switzerland, 6500
Contact: Begoña Lipp von Wattenwyl, Dr.    0041 91 811 9438    BegonaMaria.LippVonWattenwyl@eoc.ch   
Spital Wetzikon Recruiting
Wetzikon, ZH, Switzerland, 8620
Contact: Denise Beck, Dr.       denise.beck@gzo.ch   
Contact: Marta Bachmann    0041 44 934 28 49    marta.bachmann@gzo.ch   
Brust Centrum Zürich, Bethanien & Zollikerberg Recruiting
Zollikerberg, ZH, Switzerland, 8125
Contact: Hisham Fansa, Prof. Dr.       hisham.fansa@spitalzollikerberg.ch   
Contact: Irene Brenneisen    0041 44 397 24 01    irene.brenneisen@spitalzollikerberg.ch   
Stadtspital Triemli Recruiting
Zürich, ZH, Switzerland, 8063
Contact: Heike Passmann, Dr.    0041 44 416 11 11    Heike.Passmann@triemli.zuerich.ch   
Contact: Barbara Herzog       Barbara.Herzog@triemli.zuerich.ch   
Campus SLB Sonnenhof AG Recruiting
Bern, Switzerland, 3001
Contact: Yves Brühlmann, Dr.    0041 31 309 95 30    yves.bruehlmann@plast.ch   
Contact: Cindy Groen       cindy.groen@lindenhofgruppe.ch   
Sub-Investigator: Gilles Berclaz, Prof. Dr.         
Universitätsspital Zürich, Klinik für Gynäkologie Recruiting
Zürich, Switzerland, 8091
Contact: Heike Frauchiger-Heuer, Dr.    0041 44 255 52 00    heike.frauchiger-heuer@usz.ch   
Contact: Isabel Breyer       Isabel.breyer@usz.ch   
Sponsors and Collaborators
Thurgau Breast Center
Investigators
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Principal Investigator: Mathias Fehr, Prof. Dr. Brustzentrum Thurgau, Kantonsspital Frauenfeld
More Information
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Responsible Party: Thurgau Breast Center
ClinicalTrials.gov Identifier: NCT04390529    
Other Study ID Numbers: IRMA
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: November 3, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No