Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neoadjuvant radiotherapy.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Implant Breast Reconstruction, Neoadjuvant Radiotherapy. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Radiation Neoadjuvant radiotherapy
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.
Primary outcome measures
- 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]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Xinhong Wu — Wuhan
Identifiers
NCT: NCT05992870 · NeoRTIBR