Omitting chest wall radiation after breast reconstruction
Official title: A Randomized Phase II Trial on Omission of Chest Wall Radiotherapy After Implant-Based Breast Reconstruction in Early Breast Cancer Patients
Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT06464913 · Data updated 2026-11-12
This study is testing if skipping chest wall radiation after breast reconstruction can help early-stage breast cancer patients have better recovery and quality of life without raising the chances of cancer coming back.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | Women only |
| Enrollment | 152 (estimated) |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | September 1, 2024 |
| Main results expected | September 1, 2028 |
| Study ends | September 1, 2029 |
| Registry record updated | October 15, 2024 |
| Trial ID | NCT06464913 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include early-stage breast cancer patients undergoing prosthetic reconstruction with specific tumor characteristics.
✕Probably not a fit
Patients with other active malignancies or severe organ dysfunction may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized Phase II clinical trial investigates the effects of omitting chest wall radiotherapy (RT) after prosthetic reconstruction in early-stage breast cancer patients. Participants will be randomly assigned to receive either standard RT or no chest wall RT, while still receiving RT to specific lymphatic drainage areas. The study aims to determine if this omission can reduce reconstruction failure rates and improve patients' quality of life without significantly increasing local recurrence rates. Follow-up assessments will monitor the outcomes related to reconstruction and cancer recurrence.
Why it matters
Potential benefit: If successful, this approach could lead to improved outcomes and quality of life for breast cancer patients undergoing reconstruction.
How similar studies have gone: While there is existing research on post-mastectomy radiation therapy, this specific approach of omitting chest wall RT in the context of prosthetic reconstruction is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Undergoes prosthetic reconstruction (including cold knife one-step prosthetic reconstruction or two-step expander-prosthetic reconstruction.); * Histologically confirmed invasive breast cancer patients with stage T1-2N1M0; * ECOG score of 0-1; * Indications for neoadjuvant therapy before surgery and adjuvant therapy after surgery. Exclusion Criteria: * Other metabolically active malignant tumors; * Severe dysfunction of heart, lung, liver, kidney, or other vital organs; * Uncontrolled diabetes or other endocrine diseases; * Known allergy to radiotherapy or chemotherapy drugs; * Pregnant or lactating women.
Where it's running
-
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Ting Zhang
- Email: zezht@zju.edu.cn
- Phone: +86-571-87783521
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.