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NCT Number: NCT05992870

Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Implant Breast Reconstruction Neoadjuvant Radiotherapy Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neoadjuvant radiotherapy

Radiation

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 outcomes

  1. 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.

Secondary outcomes

  1. 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

    Other adverse events following NART or surgery other than described in the primary outcome measure.

  2. Number of participants with removal of implant.

    Time frame: 6 months after surgery

    Implant are removed for postoperative complications.

  3. Patient satisfaction.

    Time frame: 3 months and 12 months after surgery

    Patient satisfaction (as measured using the BREAST-Q reconstruction module) before, 3 months after, and 12 months after surgery.

  4. Pathological complete response (pCR) assessed in skin-sparing mastectomy specimen

    Time frame: Within 2 weeks after skin-sparing mastectomy

    A pCR was defined as absence of invasive and in situ carcinoma in the breast, irrespective of nodal status (ypT0).

Study contacts

Contact information is provided by the study sponsor or research team.

Ning Zou, MD

CONTACT

[email protected]

+8615007162698

Xinhong Wu, MD

CONTACT

[email protected]

+8618602726300

Sponsors and collaborators

Lead sponsor

Hubei Cancer Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 15, 2023
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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