Breast CancerCONRADNCT07178886
Breast Reconstruction and Radiotherapy
An observational study of Breast Cancer, run by Janine M. Simons MD PhD at 1 site in Netherlands.
Trial summary
If the whole breast is removed because of breast cancer, several options for breast reconstruction are available. All these options have an increased complication risk if a patient has been or will be treated with radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 750 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Aug 2025to 31 Dec 2032
- How long will I take part?
- 5 Years
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with breast cancer (to be) treated with mastectomy who have an indication for radiotherapy and who may or may not undergo breast reconstruction will be included.
Who may be able to join
- 18 years of age or older
- Diagnosed with unilateral non-metastatic breast cancer
- (to be) Treated with mastectomy and to be treated with adjuvant radiotherapy
- Willing and able to provide written informed consent
Who cannot join
- History of DCIS or invasive breast cancer
- Previous thoracic radiotherapy treatment
- History of other malignancies (except for patients with basal or squamous cell skin cancer, in situ carcinoma of the cervix and patients who are disease-free at least 5 years following successful treatment for other malignancies)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medical Center
Rotterdam
Simone Schnitzler, MD, 0031630899908, s.schnitzler@erasmusmc.nl
About this study
Official title: Breast Reconstruction and Radiotherapy: a Nationwide Cohort Study on Care Evaluation and Optimization
If the whole breast is removed because of breast cancer, several options for breast reconstruction are available. All these options have an increased complication risk if a patient has been or will be treated with radiotherapy. However, only a few high-quality studies addressed patient satisfaction and complication risks, both in terms of timing (prior to or after irradiation) and type of reconstruction (implant or own tissue). As radiotherapy indications expand and more patients desire a reconstruction, this is a progressively relevant issue. Through this nationwide prospective study, the investigators aim to identify the most ideal treatment strategy by comparing different reconstruction options in terms of patient reported outcomes (PROs), toxicity, oncological safety and costs. These results will enable improvement of shared decision-making and cost-effectiveness of breast reconstruction strategies in case of radiotherapy.
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Mastectomy, Radiotherapy, Reconstruction, Quality of life, Patient Reported Outcomes
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All patients, 18 years or older, treated with mastectomy and radiotherapy for breast cancer. | Adult patients with breast cancer (to be) treated with mastectomy who have an indication for radiotherapy and who may or may not undergo breast reconstruction will be included. The following treatments of interest will be identified: * "immediate breast reconstruction" (implant-based or autologous) * "delayed breast reconstruction" group (implant-based or autologous) * "no breast reconstruction" group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction at 1 year
The primary objective is to assess patient reported outcomes at 1 year (after mastectomy), by means of the validated questionnaire BREAST-Q. With the BREAST-Q questionnaire, four domains will be evaluated (psychosocial well-being (score ranges from 10 to 50), physical well-being (score ranges from 10 to 30), sexual well-being (score ranges from 6 to 30) and satisfaction with breasts (score ranges from 4 to 16) and higher scores indicate better outcomes.
Measured: From enrollment to one year follow-up after treatment.
Patient quality of life at 1 year
The primary objective is to assess patient reported outcomes at 1 year (after mastectomy), by means of the validated questionnaire EQ-5D-5L.
The EQ-5D-5L questionnaire consists of two parts: the descriptive system, with a minimum value of 5 and maximum value of 25 (higher scores mean worse quality of life) and the visual analogue scale, with a minimum value of 0 and maximum value of 100 (higher scores mean better quality of life).
Measured: From enrollment to one year follow-up after treatment.
Secondary outcomes (7)
Patient satisfaction at 3 and 5 years
To assess patient reported outcomes at 3, and 5 years (after mastectomy), by means of the validated questionnaire BREAST-Q. With the BREAST-Q questionnaire, four domains will be evaluated (psychosocial well-being (score ranges from 10 to 50), physical well-being (score ranges from 10 to 30), sexual well-being (score ranges from 6 to 30) and satisfaction with breasts (score ranges from 4 to 16) and higher scores indicate better outcomes.
Measured: From enrollment to 3 and 5 years follow-up after treatment.
Patient quality of life at 3 and 5 years
To assess patient reported outcomes at 3, and 5 years (after mastectomy), by means of the validated questionnaire EQ-5D-5L. The EQ-5D-5L questionnaire consists of two parts: the descriptive system, with a minimum value of 5 and maximum value of 25 (higher scores mean worse quality of life) and the visual analogue scale, with a minimum value of 0 and maximum value of 100 (higher scores mean better quality of life).
Measured: From enrollment to 3 and 5 years follow-up after treatment.
Complications prior to and following radiotherapy
To assess complication rates prior to and after radiotherapy (e.g., total number of surgical reinterventions, reconstruction failure, capsular contracture, fibrosis, pain). Data on type of complications and complication rates (categorized as early (<90 days after surgery) or late (>90 days after surgery will be collected
Measured: From enrollment to end of study follow-up (i.e. 5 years after treatment).
Cost-effectiveness and consumption of medical care and materials.
The main outcomes of the economic evaluation will be the incremental cost-effectiveness per life-year gained and per quality-adjusted life-year gained. Primary care resource use (e.g., visits to the general practitioner, physiotherapist and home care) will be collected using the iMTA Medical Consumption Questionnaire (iMCQ), Productivity Cost Questionnaire (iPCQ) and Valuation of Informal Care Questionnaire (iVICQ) and administered at baseline (after surgery and before radiotherapy) and 3 months after surgery. Secondary care resource use (e.g., inpatient days, outpatient visits, RT and surgery procedures) will be obtained through DHD.
Measured: Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable).
Time to adjuvant treatment (radiotherapy/systemic therapy).
To assess time to adjuvant oncologic treatment (radiotherapy/systemic therapy)
Measured: Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable).
Breast cancer recurrence rates at 3, and 5 years
Regarding breast cancer recurrence and time-to-event analysis, any (invasive or in situ) local, regional or distant recurrence will be registered as a recurrence event. The locoregional recurrence rate is defined as the time from diagnosis to a local and/or regional recurrence. The distant recurrence rate is defined as the time from diagnosis to a distant recurrence.
Measured: Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable).
Recurrence free interval, disease free survival and overall survival at 3 and 5 years.
The recurrence-free interval is defined as the time from diagnosis to any event related to breast cancer, including death from breast cancer. Disease free survival is defined as the time from diagnosis to any event related to breast cancer or death (irrespective of cause of death). Overall survival is defined as the time from diagnosis to death from any cause. Patients will be censored if lost to follow-up before 5 years of follow-up or if they are alive at 5 years follow-up.
Measured: Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start22 Aug 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 750 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Janine M. Simons MD PhD
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Maastro Clinic, The Netherlands
- Responsible party
- Sponsor-investigator, Janine M. Simons MD PhD, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178886
- Sponsor's protocol ID
- 10390032310055
- Other IDs
- 10390032310055
- Acronym
- CONRAD
- Status last verified
- Sep 2025
- First submitted
- 21 Feb 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Other scientist can contact the PI and request data. The purpose of the request should be provided in writing. If a data transfer is agreed upon, the data will be shared according to the Erasmus MC guidelines on data security and after a DTA has been signed by both parties.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Reconstruction and Radiotherapy: a Nationwide Cohort Study on Care Evaluation and Optimization
- ClinicalTrials.gov ID
- NCT07178886
- Acronym / sponsor ID
- CONRAD / 10390032310055
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Mastectomy, Radiotherapy, Reconstruction, Quality of life, Patient Reported Outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Janine M. Simons MD PhDUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Maastro Clinic, The Netherlands
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
If the whole breast is removed because of breast cancer, several options for breast reconstruction are available. All these options have an increased complication risk if a patient has been or will be treated with radiotherapy. However, only a few high-quality studies addressed patient satisfaction and complication risks, both in terms of timing (prior to or after irradiation) and type of reconstruction (implant or own tissue). As radiotherapy indications expand and more patients desire a reconstruction, this is a progressively relevant issue. Through this nationwide prospective study, the investigators aim to identify the most ideal treatment strategy by comparing different reconstruction options in terms of patient reported outcomes (PROs), toxicity, oncological safety and costs. These results will enable improvement of shared decision-making and cost-effectiveness of breast reconstruction strategies in case of radiotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients, 18 years or older, treated with mastectomy and radiotherapy for breast cancer. | – | –Adult patients with breast cancer (to be) treated with mastectomy who have an indication for radiotherapy and who may or may not undergo breast reconstruction will be included. The following treatments of interest will be identified: * "immediate breast reconstruction" (implant-based or autologous) * "delayed breast reconstruction" group (implant-based or autologous) * "no breast reconstruction" group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with breast cancer (to be) treated with mastectomy who have an indication for radiotherapy and who may or may not undergo breast reconstruction will be included.
Key inclusion criteria (4 listed)
- 18 years of age or older
- Diagnosed with unilateral non-metastatic breast cancer
- (to be) Treated with mastectomy and to be treated with adjuvant radiotherapy
- Willing and able to provide written informed consent
Key exclusion criteria (3 listed)
- History of DCIS or invasive breast cancer
- Previous thoracic radiotherapy treatment
- History of other malignancies (except for patients with basal or squamous cell skin cancer, in situ carcinoma of the cervix and patients who are disease-free at least 5 years following successful treatment for other malignancies)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient satisfaction at 1 year
Time frame: From enrollment to one year follow-up after treatment.
The primary objective is to assess patient reported outcomes at 1 year (after mastectomy), by means of the validated questionnaire BREAST-Q. With the BREAST-Q questionnaire, four domains will be evaluated (psychosocial well-being (score ranges from 10 to 50), physical well-being (score ranges from 10 to 30), sexual well-being (score ranges from 6 to 30) and satisfaction with breasts (score ranges from 4 to 16) and higher scores indicate better outcomes.
Patient quality of life at 1 year
Time frame: From enrollment to one year follow-up after treatment.
The primary objective is to assess patient reported outcomes at 1 year (after mastectomy), by means of the validated questionnaire EQ-5D-5L. The EQ-5D-5L questionnaire consists of two parts: the descriptive system, with a minimum value of 5 and maximum value of 25 (higher scores mean worse quality of life) and the visual analogue scale, with a minimum value of 0 and maximum value of 100 (higher scores mean better quality of life).
7 secondary outcomes
Patient satisfaction at 3 and 5 years
Time frame: From enrollment to 3 and 5 years follow-up after treatment.
Patient quality of life at 3 and 5 years
Time frame: From enrollment to 3 and 5 years follow-up after treatment.
Complications prior to and following radiotherapy
Time frame: From enrollment to end of study follow-up (i.e. 5 years after treatment).
Cost-effectiveness and consumption of medical care and materials.
Time frame: Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable).
Time to adjuvant treatment (radiotherapy/systemic therapy).
Time frame: Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable).
Breast cancer recurrence rates at 3, and 5 years
Time frame: Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable).
Recurrence free interval, disease free survival and overall survival at 3 and 5 years.
Time frame: Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: Yes. Other scientist can contact the PI and request data. The purpose of the request should be provided in writing. If a data transfer is agreed upon, the data will be shared according to the Erasmus MC guidelines on data security and after a DTA has been signed by both parties.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Janine M. Simons MD PhD at 1 site in Netherlands.
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 3 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: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Contact Janine M Simons, MD PhD (0031107040521, j.simons@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction at 1 year (time frame: From enrollment to one year follow-up after treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2025.