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Breast Cancer FemaleIRMANCT04390529

Immediate Breast Reconstruction Following Mastectomy (IRMA)

An observational study of Breast Cancer Female, run by Thurgau Breast Center at 15 sites in Switzerland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer Female
What is being tested?
quality-of-life questionnaire: BREAST-Q
How many people
515 participants
Where
15 sitesSwitzerland
Study dates
1 Jan 2018to 30 Apr 2030
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • Women only
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • Unwillingness to have follow-up assessments at the participating breast centers
  • Limited ability to understand study-specific procedures, which includes language difficulties.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Switzerland15 sites

  • Kantonsspital Aarau AG

    Aarau, Canton of Aargau, 5001

  • Kantonsspital Baden, Prof. Dr. med. Cornelia Leo

    Baden, Canton of Aargau, 5404

  • Brustzentrum Bern Biel, Hirslanden

    Bern, Canton of Bern, 3013

  • Campus SLB Sonnenhof AG

    Bern, 3001

  • Centre du Sein de Genève - Hirslanden Clinique des Grangettes

    Chêne-Bougeries, Canton of Geneva, 1224

  • Brustzentrum Thurgau, Spital Thurgau AG, Prof. Dr. med. Mathias K. Fehr

    Frauenfeld, Thurgau, 8500

  • HUG - Hôpitaux universitaires de Genève

    Geneva, 1205

  • Ente Ospedaliero Cantonale (Ospedale Regionale di Bellinzona e Valli and Ospedale Regionale di Lugano)

    Lugano, Canton Ticino, 6500

  • Tumor- und Brustzentrum ZeTuP

    Sankt Gallen, Canton of St. Gallen, 9006

  • Brustzentrum Ostschweiz

    Sankt Gallen, Canton of St. Gallen, 9016

  • Tumor- und BrustZentrum Ostschweiz

    Sankt Gallen, Canton of St. Gallen, 9016

  • Spital Wetzikon

    Wetzikon, Canton of Zurich, 8620

  • Brust Centrum Zürich, Bethanien & Zollikerberg

    Zollikerberg, Canton of Zurich, 8125

  • Stadtspital Triemli

    Zurich, Canton of Zurich, 8063

  • Universitätsspital Zürich, Klinik für Gynäkologie

    Zurich, 8091

Other trials in Switzerland

About this study

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

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.

Read the 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.

Being tested
quality-of-life questionnaire: BREAST-Q

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • quality-of-life questionnaire: BREAST-QOther

    quality-of-life questionnaire: BREAST-Q

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Three years after surgery

  2. Rate of infection requiring surgery

    Postoperative follow-up assessments include the documentation of infections requiring surgery

    Measured: Three years after surgery

  3. Grade of surgical complications

    Postoperative follow-up assessments include the documentation of surgical complications (grading according to Clavien-Dindo Classification of Surgical Complications)

    Measured: Three years after surgery

Secondary outcomes (4)

  1. 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

    Measured: Three years after surgery

  2. Level of patient satisfaction with cosmesis

    Postoperative follow-up assessment using BREAST-Q quality-of-life questionnaire that measures patient satisfaction with cosmetic outcome

    Measured: Five years after surgery

  3. Level of sensitivity of the operated breast (NAC) compared to the non-operated breast

    Postoperative follow-up assessments of breast functional outcomes

    Measured: Five years after surgery

  4. 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

    Measured: Five years after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2020
  2. Study start1 Jan 2018
  3. Primary completion30 Apr 2030 (estimated)
  4. Study completion30 Apr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
515 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04390529
Sponsor's protocol ID
IRMA
Acronym
IRMA
Status last verified
May 2025
First submitted
27 Apr 2020
Last updated
15 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer Female, run by Thurgau Breast Center at 15 sites in Switzerland.

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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Switzerland. 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?

This study is still under way. Results are not available in the source record yet.

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?

Rate of nipple-areola complex (NAC) or skin flap necrosis requiring specific treatment/surgery (time frame: Three years after surgery). 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 NCT04390529.

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 15 May 2025.

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