Clinical trial NCT05992870: Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction
Official title: Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Implant Breast Reconstruction
Neoadjuvant Radiotherapy
Keywords: neoadjuvant radiotherapy, implant, breast reconstruction
Lead sponsor: Hubei Cancer Hospital
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

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

Primary outcomes:
measure: Postoperative complications at 3 months following skin-sparing mastectomy and immediate implant-based breast reconstruction after NART
timeFrame: 3 months following skin-sparing mastectomy and immediate breast reconstruction
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 .
timeFrame: Within 3 months after both breast reconstruction and radiotherapy
measure: Number of participants with removal of implant.
timeFrame: 6 months after surgery
measure: Patient satisfaction.
timeFrame: 3 months and 12 months after surgery
measure: Pathological complete response (pCR) assessed in skin-sparing mastectomy specimen
timeFrame: Within 2 weeks after skin-sparing mastectomy
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Xinhong Wu
state: Hubei
Study officials:
References: