Randomized Phase II Trial: Chest Wall RT Omission After Prosthetic Reconstruction

NCT06464913 | Recruiting Phase 2

• 1 other identifier: Y2024-0423
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Keywords

Post-mastectomy radiation therapy; Implant-based breast reconstruction; Local recurrence; Reconstruction failure

Outcome Measures

Primary Outcomes (2)

• Reconstruction failure rate (Capsular Contracture Grade III or higher)

  Physicians assess the hardness, shape of the breast, and the presence of any abnormal hard lumps or asymmetry through palpation. According to the Baker classification system, capsular contracture is divided into four grades; Grades I and II typically have no clinical significance, while Grades III and IV require further evaluation and possible treatment. Breast Ultrasound or Chest CT is used to assess the condition of the implant and surrounding tissues. Particularly, the thickening of the fibrous capsule is considered an objective sign of capsular contracture. In cases where the results of the ultrasound examination are unclear or a more detailed assessment is needed, MRI may be required to evaluate the implant and surrounding tissues.

  2 years postoperatively

• The 3-year local recurrence rate (LRR)

  The 3-year LRR refers to the proportion of patients who experience a cancer recurrence within the breast tissue or chest wall area, or in the regional lymph nodes, within three years following the initial treatment. To determine the local recurrence rate, medical professionals: Conduct regular follow-up examinations, including physical assessments and patient-reported symptoms. Utilize imaging techniques such as mammography, ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI) when indicated. May also consider the use of tumor markers in blood tests to monitor for signs of recurrence.

  3 years postoperatively

Secondary Outcomes (3)

• Breast-Q score

  2 years postoperatively

• PROs and QoL score

  3 years postoperatively

• 3-year disease free survival rate (DFS)

  3 years postoperatively

Study Arms (2)

No Chest Wall RT

EXPERIMENTAL

This group will have chest wall RT omitted and will only receive RT to the supraclavicular and infraclavicular lymphatic drainage areas.

Radiation: With or without chest wall RT

Traditional RT

ACTIVE COMPARATOR

This group will receive standard RT to the chest wall and supraclavicular and infraclavicular lymphatic drainage areas.

Radiation: With or without chest wall RT

Interventions

With or without chest wall RT RADIATION

Supraclavicular and infraclavicular lymphatic drainage area radiotherapy with or without chest wall RT

No Chest Wall RT; Traditional RT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Ting Zhang

CONTACT

+86-571-87783521; zezht@zju.edu.cn

Yucui ZHAO

CONTACT

+86 18818270910; yucui_zhao@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-label design, where the assessors are not blinded to the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 18, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: October 15, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)