NCT06464913 Randomized Phase II Trial: Chest Wall RT Omission After Prosthetic Reconstruction
| NCT ID | NCT06464913 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Condition | Breast Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 152 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 152 participants in total. It began in 2024-09-01 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this randomized Phase II clinical trial is to test the effects of omitting chest wall radiotherapy (RT) after prosthetic reconstruction in early-stage breast cancer patients. The main questions it aims to answer are: * Can omitting chest wall RT after prosthetic reconstruction reduce the failure rate of breast reconstruction without significantly increasing the local recurrence rate? * Does this approach ensure an improvement in the quality of life for patients without sacrificing therapeutic effectiveness? Participants will: * Be randomly assigned to one of two groups. * One group will receive standard RT to the chest wall and supraclavicular and infraclavicular lymphatic drainage areas. * The other group will have chest wall RT omitted and will only receive RT to the supraclavicular and infraclavicular lymphatic drainage areas. * Participate in follow-up assessments to monitor reconstruction failure rates and local recurrence rates. If there is a comparison group: Researchers will compare the outcomes of the two groups to evaluate the impact of chest wall RT omission on reconstruction failure and local recurrence risks.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06464913 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Breast Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06464913 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06464913 currently recruiting?
Yes, NCT06464913 is actively recruiting participants. Contact the research team at zezht@zju.edu.cn for enrollment information.
Where is the NCT06464913 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06464913 clinical trial?
NCT06464913 is sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. The trial plans to enroll 152 participants.