Breast CancerNCT07798466
Immediate Autologous Tissue Breast Reconstruction and Radiotherapy Strategy After Breast Cancer Surgery
An observational study of Breast Cancer and Breast Reconstruction, run by Fudan University at 1 site in China.
Trial summary
This is a prospective, open-label, controlled clinical trial aiming to investigate the optimal sequencing strategy between immediate autologous tissue breast reconstruction and radiotherapy in breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Reconstruction, Radiotherapy
- What is being tested?
- Immediate DIEP flap breast reconstruction and Hypofractionated radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 1 Nov 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Female patients diagnosed with breast cancer who receive immediate autologous-tissue breast reconstruction after mastectomy, with or without postoperative radiotherapy.
Who may be able to join
- Aged 18 years or older
- Female
- Pathologically confirmed invasive breast cancer prior to surgery
- Planned to receive neoadjuvant chemotherapy
- No clinical or radiographic evidence of distant metastasis
- Meets indication for postmastectomy radiotherapy (PMRT)
- Willing to undergo immediate autologous free flap breast reconstruction using abdominal tissue
- Able and willing to provide written informed consent
Who cannot join
- Completed neoadjuvant chemotherapy with no current indication for adjuvant radiotherapy
- Disease progression during neoadjuvant chemotherapy, failing to complete the planned regimen
- Pregnant or lactating women
- History of diabetes mellitus
- History of heavy smoking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Clinical Study of Immediate Autologous Tissue Breast Reconstruction and Radiotherapy-Related Diagnosis-Treatment Strategy After Breast Cancer Surgery
This is a prospective, open-label, controlled clinical trial aiming to investigate the optimal sequencing strategy between immediate autologous tissue breast reconstruction and radiotherapy in breast cancer patients. Eligible participants are female breast cancer patients who have completed neoadjuvant chemotherapy and are scheduled to undergo total mastectomy combined with immediate free abdominal flap (DIEP) breast reconstruction. Participants will be assigned to receive either preoperative radiotherapy followed by reconstruction, or postoperative adjuvant radiotherapy after reconstruction. The primary objectives are to compare surgical safety, oncological safety, patient-reported outcomes (PRO), and aesthetic evaluation between the two radiotherapy sequencing strategies. Secondary objectives include optimizing radiotherapy techniques, radiation doses, and target volume delineation for immediate abdominal free flap reconstruction; exploring the impact of hypofractionated radiotherapy on reconstruction-related complications; investigating the association between multi-omics and immune microenvironment changes and radiotherapy efficacy; and exploring the mechanism by which skin microbiota characteristics affect radiation-induced skin injury through modulation of the skin immune microenvironment. This study hopes to provide clinical evidence for establishing the optimal treatment sequence of immediate breast reconstruction and radiotherapy.
- Conditions
- Breast Cancer, Breast Reconstruction, Radiotherapy
- Being tested
- Immediate DIEP flap breast reconstruction, Hypofractionated radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate DIEP flap breast reconstructionProcedure or surgery
Autologous breast reconstruction using deep inferior epigastric perforator (DIEP) flap, performed by experienced plastic surgeons, with standard perforator dissection and microsurgical vascular anastomosis.
Hypofractionated radiotherapyRadiation
Standard hypofractionated radiotherapy delivered to the breast region with consistent radiation dose, fractionation protocol and radiotherapy technique for all enrolled patients.
| Study group | Role | What they receive |
|---|---|---|
| Pre-operative Radiotherapy Group | Patients receive pre-operative radiotherapy, followed by immediate DIEP flap breast reconstruction surgery. Post-operative rehabilitation and regular follow-up will be performed Receives: Procedure: Immediate DIEP flap breast reconstruction; Radiation: Hypofractionated radiotherapy | |
| Post-operative Radiotherapy Group | Patients undergo immediate DIEP flap breast reconstruction surgery first, followed by post-operative radiotherapy. Post-operative rehabilitation and regular follow-up will be performed. Receives: Procedure: Immediate DIEP flap breast reconstruction; Radiation: Hypofractionated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported breast satisfaction assessed by BREAST-Q 2.0 scale
Patient-reported outcome (PRO) of breast satisfaction will be measured using the validated Chinese version of BREAST-Q 2.0 questionnaire, including satisfaction with breast appearance, surgical outcome, psychosocial well-being and physical well-being.
Measured: 12-month after DIEP flap reconstruction surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Sep 2025
- Primary completion1 Nov 2025
- Study completion1 Nov 2026 (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.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiong Wu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798466
- Sponsor's protocol ID
- CAPPELALA
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Immediate Autologous Tissue Breast Reconstruction and Radiotherapy-Related Diagnosis-Treatment Strategy After Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT07798466
- Acronym / sponsor ID
- CAPPELALA
- Conditions
- Breast Cancer, Breast Reconstruction, Radiotherapy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 1 Sep 2026 (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.
This is a prospective, open-label, controlled clinical trial aiming to investigate the optimal sequencing strategy between immediate autologous tissue breast reconstruction and radiotherapy in breast cancer patients. Eligible participants are female breast cancer patients who have completed neoadjuvant chemotherapy and are scheduled to undergo total mastectomy combined with immediate free abdominal flap (DIEP) breast reconstruction. Participants will be assigned to receive either preoperative radiotherapy followed by reconstruction, or postoperative adjuvant radiotherapy after reconstruction. The primary objectives are to compare surgical safety, oncological safety, patient-reported outcomes (PRO), and aesthetic evaluation between the two radiotherapy sequencing strategies. Secondary objectives include optimizing radiotherapy techniques, radiation doses, and target volume delineation for immediate abdominal free flap reconstruction; exploring the impact of hypofractionated radiotherapy on reconstruction-related complications; investigating the association between multi-omics and immune microenvironment changes and radiotherapy efficacy; and exploring the mechanism by which skin microbiota characteristics affect radiation-induced skin injury through modulation of the skin immune microenvironment. This study hopes to provide clinical evidence for establishing the optimal treatment sequence of immediate breast reconstruction and radiotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-operative Radiotherapy Group | – | Procedure: Immediate DIEP flap breast reconstruction, Radiation: Hypofractionated radiotherapyPatients receive pre-operative radiotherapy, followed by immediate DIEP flap breast reconstruction surgery. Post-operative rehabilitation and regular follow-up will be performed |
| Post-operative Radiotherapy Group | – | Procedure: Immediate DIEP flap breast reconstruction, Radiation: Hypofractionated radiotherapyPatients undergo immediate DIEP flap breast reconstruction surgery first, followed by post-operative radiotherapy. Post-operative rehabilitation and regular follow-up will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients diagnosed with breast cancer who receive immediate autologous-tissue breast reconstruction after mastectomy, with or without postoperative radiotherapy.
Key inclusion criteria (8 listed)
- Aged 18 years or older
- Female
- Pathologically confirmed invasive breast cancer prior to surgery
- Planned to receive neoadjuvant chemotherapy
- No clinical or radiographic evidence of distant metastasis
Key exclusion criteria (5 listed)
- Completed neoadjuvant chemotherapy with no current indication for adjuvant radiotherapy
- Disease progression during neoadjuvant chemotherapy, failing to complete the planned regimen
- Pregnant or lactating women
- History of diabetes mellitus
- History of heavy smoking
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 |
|---|---|---|
| Immediate DIEP flap breast reconstructionAutologous breast reconstruction using deep inferior epigastric perforator (DIEP) flap, performed by experienced plastic surgeons, with standard perforator dissection and microsurgical vascular anastomosis. | Procedure or surgery | Post-operative Radiotherapy Group, Pre-operative Radiotherapy Group |
| Hypofractionated radiotherapyStandard hypofractionated radiotherapy delivered to the breast region with consistent radiation dose, fractionation protocol and radiotherapy technique for all enrolled patients. | Radiation | Post-operative Radiotherapy Group, Pre-operative Radiotherapy Group |
Primary outcome
Patient-reported breast satisfaction assessed by BREAST-Q 2.0 scale
Time frame: 12-month after DIEP flap reconstruction surgery
Patient-reported outcome (PRO) of breast satisfaction will be measured using the validated Chinese version of BREAST-Q 2.0 questionnaire, including satisfaction with breast appearance, surgical outcome, psychosocial well-being and physical well-being.
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 1 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Breast Reconstruction, run by Fudan University 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 8 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: enrolling by invitation, as of the sponsor's last update on 1 Sep 2026. 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?
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?
Patient-reported breast satisfaction assessed by BREAST-Q 2.0 scale (time frame: 12-month after DIEP flap reconstruction surgery). 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 1 Sep 2026.