Breast CancerNCT05992870
Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction
A study testing Neoadjuvant radiotherapy in people with Breast Cancer and Implant Breast Reconstruction, run by Hubei Cancer Hospital at 1 site in China.
Trial summary
Neoadjuvant radiotherapy(NART) followed by mastectomy and immediate DIEP flap reconstruction is feasible and technically safe. However, reports of NACT followed immediate implant-based breast reconstruction are rare. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Implant Breast Reconstruction, Neoadjuvant Radiotherapy
- What is being tested?
- Neoadjuvant radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2023to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women >18 years with histopathologically-confirmed breast cancer, who:
- require mastectomy for any reason
- a known indication for (adjuvant) radiotherapy
- require implant-based breast reconstruction
Who cannot join
- Inability to give informed consent
- MDT unable to make recommendation for radiotherapy based on pre-operative histopathological and imaging findings
- Previous history of breast cancer or another malignancy for which radiotherapy of the breast or axilla
- Pregnant or lactating
- inflammatory breast cancer
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xinhong Wu
Wuhan, Hubei, 430079
Xinhong Wu, MD, +8618602726300, 34053889@qq.com
Ning Zou, MD, +8615007162698, sunnyning116@163.com
About this study
Neoadjuvant radiotherapy(NART) followed by mastectomy and immediate DIEP flap reconstruction is feasible and technically safe. However, reports of NACT followed immediate implant-based breast reconstruction are rare. Some studies have shown that NART followed immediate implant-based breast reconstruction seems feasible and can be safely attempted. It's well known that radiotherapy after implant-based breast reconstruction have negative effects on implant and cosmetic results. So, investigators conducted a polit study to learn about acute post-surgical complications following skin-sparing mastectomy and immediate implant-based breast reconstruction after NART.
Read the detailed description
Radiotherapy after implant-based breast reconstruction have negative effects on implant and cosmetic results, including severe capsular contracture, mastectomy flap necrosis ,reoperation and so on. Postmastectomy radiotherapy( PMRT )is associated with implant reconstruction failure. PRADA study has shown neoadjuvant radiotherapy followed by skin-sparing mastectomy and immediate DIEP flap reconstruction is feasible and technically safe. The investigators assume that neoadjuvant radiotherapy can avoid the negative effects of PMRT on an implant and the capsule of an implant and would lead to better cosmetic results and less complications compared to PMRT. Furthermore, some studies have shown that NART could potentially result in shorter time between diagnosis and treatment completion. So, investigators conducted a polit study to learn about acute post-surgical complications following skin-sparing mastectomy and immediate implant-based breast reconstruction after NART.
- Being tested
- Neoadjuvant radiotherapy
- Keywords
- neoadjuvant radiotherapy, implant, breast reconstruction
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant radiotherapyRadiation
In case of neoadjuvant chemotherapy, RT will start 3-4 weeks after the last course of chemotherapy. A dose of 15 x 2.67 Gy 5 fractions or 16 x 2.67Gy 5 fractions per week.
A skin-sparing mastectomy and a immediate implant-based breast reconstruction will be performed, approximately 2-6 weeks after latest radiotherapy treatment.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant radiotherapy group | Experimental | Radiotherapy followed by skin-sparing mastectomy and immediate implant-based reconstruction in HBCH Receives: Radiation: Neoadjuvant radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications at 3 months following skin-sparing mastectomy and immediate implant-based breast reconstruction after NART
Surgical complications are defined as any complication requiring surgical intervention necessary within a period up to three months after the final reconstruction. Including Infection, hematoma , loss of implant or flap, fat necrosis, wound breakdown,defined and scored using the C-DC37.
Measured: 3 months following skin-sparing mastectomy and immediate breast reconstruction
Secondary outcomes (4)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 .
Other adverse events following NART or surgery other than described in the primary outcome measure.
Measured: Within 3 months after both breast reconstruction and radiotherapy
Number of participants with removal of implant.
Implant are removed for postoperative complications.
Measured: 6 months after surgery
Patient satisfaction.
Patient satisfaction (as measured using the BREAST-Q reconstruction module) before, 3 months after, and 12 months after surgery.
Measured: 3 months and 12 months after surgery
Pathological complete response (pCR) assessed in skin-sparing mastectomy specimen
A pCR was defined as absence of invasive and in situ carcinoma in the breast, irrespective of nodal status (ypT0).
Measured: Within 2 weeks after skin-sparing mastectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start8 Jul 2023
- Primary completion8 Jul 2025 (estimated)
- Study completion31 Oct 2025 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hubei Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinhong Wu, PhD, Hubei Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992870
- Sponsor's protocol ID
- NeoRTIBR
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2023
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction
- ClinicalTrials.gov ID
- NCT05992870
- Acronym / sponsor ID
- NeoRTIBR
- Keywords
- neoadjuvant radiotherapy, implant, breast reconstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hubei Cancer HospitalUniversity, hospital or other
- Study start
- 8 Jul 2023 (actual)
- Primary completion
- 8 Jul 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 15 Aug 2023 (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.
Neoadjuvant radiotherapy(NART) followed by mastectomy and immediate DIEP flap reconstruction is feasible and technically safe. However, reports of NACT followed immediate implant-based breast reconstruction are rare. Some studies have shown that NART followed immediate implant-based breast reconstruction seems feasible and can be safely attempted. It's well known that radiotherapy after implant-based breast reconstruction have negative effects on implant and cosmetic results. So, investigators conducted a polit study to learn about acute post-surgical complications following skin-sparing mastectomy and immediate implant-based breast reconstruction after NART.
Detailed description
Radiotherapy after implant-based breast reconstruction have negative effects on implant and cosmetic results, including severe capsular contracture, mastectomy flap necrosis ,reoperation and so on. Postmastectomy radiotherapy( PMRT )is associated with implant reconstruction failure. PRADA study has shown neoadjuvant radiotherapy followed by skin-sparing mastectomy and immediate DIEP flap reconstruction is feasible and technically safe. The investigators assume that neoadjuvant radiotherapy can avoid the negative effects of PMRT on an implant and the capsule of an implant and would lead to better cosmetic results and less complications compared to PMRT. Furthermore, some studies have shown that NART could potentially result in shorter time between diagnosis and treatment completion. So, investigators conducted a polit study to learn about acute post-surgical complications following skin-sparing mastectomy and immediate implant-based breast reconstruction after NART.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant radiotherapy group | Experimental | Radiation: Neoadjuvant radiotherapyRadiotherapy followed by skin-sparing mastectomy and immediate implant-based reconstruction in HBCH |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- require mastectomy for any reason
- a known indication for (adjuvant) radiotherapy
- require implant-based breast reconstruction
Key exclusion criteria (5 listed)
- Inability to give informed consent
- MDT unable to make recommendation for radiotherapy based on pre-operative histopathological and imaging findings
- Previous history of breast cancer or another malignancy for which radiotherapy of the breast or axilla
- Pregnant or lactating
- inflammatory breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoadjuvant radiotherapyIn case of neoadjuvant chemotherapy, RT will start 3-4 weeks after the last course of chemotherapy. A dose of 15 x 2.67 Gy 5 fractions or 16 x 2.67Gy 5 fractions per week. A skin-sparing mastectomy and a immediate implant-based breast reconstruction will be performed, approximately 2-6 weeks after latest radiotherapy treatment. | Radiation | Neoadjuvant radiotherapy group |
Primary outcome
Postoperative complications at 3 months following skin-sparing mastectomy and immediate implant-based breast reconstruction after NART
Time frame: 3 months following skin-sparing mastectomy and immediate breast reconstruction
Surgical complications are defined as any complication requiring surgical intervention necessary within a period up to three months after the final reconstruction. Including Infection, hematoma , loss of implant or flap, fat necrosis, wound breakdown,defined and scored using the C-DC37.
4 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 .
Time frame: Within 3 months after both breast reconstruction and radiotherapy
Number of participants with removal of implant.
Time frame: 6 months after surgery
Patient satisfaction.
Time frame: 3 months and 12 months after surgery
Pathological complete response (pCR) assessed in skin-sparing mastectomy specimen
Time frame: Within 2 weeks after skin-sparing mastectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: No. Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neoadjuvant radiotherapy in people with Breast Cancer and Implant Breast Reconstruction, run by Hubei Cancer Hospital at 1 site in China.
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 5 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: status not confirmed, as of the sponsor's last update on 17 Mar 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinhong Wu, MD (+8618602726300, 34053889@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications at 3 months following skin-sparing mastectomy and immediate implant-based breast reconstruction after NART (time frame: 3 months following skin-sparing mastectomy and immediate breast reconstruction). 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 Mar 2025.