A Study of an Alternative Treatment Approach (Preoperative Radiotherapy, Then Mastectomy, Then Immediate Reconstruction Surgery) in People With T4 Breast Cancer

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05412225
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

The purpose of this study to test an alternative treatment approach that involves giving participants radiotherapy before their mastectomy (preoperative radiotherapy) and performing immediate reconstruction surgery at the time of mastectomy. The immediate reconstruction surgery is called an immediate autologous reconstruction (IR) and is different than the standard reconstruction surgery people with T4 breast cancer have. IR is a surgical procedure where immediately following your mastectomy, the surgeon takes tissue from another part of your body and uses it to re-create your breast. The standard reconstruction surgery occurs later and can be done with an implant or tissue from your body.

The main purpose of this study to find out if the alternative treatment approach shown above is feasible. The study will see how safe this alternative treatment approach is compared with the standard treatment approach.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Invasive Breast Cancer	Diagnostic Test: Pre-neoadjuvant radiotherapy (NART) biopsy; Radiation: Neoadjuvant radiotherapy; Procedure: Unilateral total mastectomy with axillary lymph node dissection	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Feasibility of Preoperative Radiotherapy in T4 Breast Cancer Patients Who Are Responders to Neoadjuvant Chemotherapy to Allow for Immediate Reconstruction: A Prospective Study
• Actual Study Start Date: Jun 6, 2022
• Anticipated Primary Completion Date: Jun 6, 2025
• Anticipated Study Completion Date: Jun 6, 2025

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Participants with clinical T4 biopsy-proven breast cancer Participants with clinical T4 biopsy-proven breast cancer with no evidence of distant metastases who demonstrate a complete or partial response to standard neoadjuvant chemotherapy/NAC and desire immediate autologous reconstruction/IR will be eligible to enroll.

Diagnostic Test: Pre-neoadjuvant radiotherapy (NART) biopsy; Participants will undergo pre-NART core biopsy guided by post-NAC MRI to the area of residual enhancement or to the previously biopsied cancer if no residual enhancement remains; Radiation: Neoadjuvant radiotherapy; After biopsy, participants will undergo neoadjuvant radiotherapy/NART; Other Names: NART ; Procedure: Unilateral total mastectomy with axillary lymph node dissection; At 2-6 weeks after completion of NART, participants will undergo unilateral MRM (total mastectomy with axillary lymph node dissection), with resection of all involved breast skin. Skin-sparing mastectomy will not be permitted.; Other Names: MRM

Outcome Measures

Primary Outcome Measures

1. Compare the rate of wound complications for partners who receive neoadjuvant radiotherapy (NART) and modified radical mastectomy with immediate autologous reconstruction (IR) following neoadjuvant chemotherapy (NAC) compared w/current standard of care [5 years]

   Prospectively assess the feasibility of neoadjuvant radiotherapy (NART) and modified radical mastectomy with immediate autologous reconstruction (IR) following neoadjuvant chemotherapy (NAC) in patients with clinical T4 breast cancer, compared with the current standard of care ( [NAC, modified radical mastectomy [MRM] with delayed reconstruction, and postmastectomy radiotherapy [PMRT]), by assessing the rate of wound complications (surgical site infection [SSI], reoperative intervention, and flap failure)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Female sex, aged ≥18 years, with biopsy-proven invasive breast cancer

• cT4 cN0-3 tumor

• Partial or complete response to NAC on imaging and clinical examination using the Response Evaluation Criteria in Solid Tumors (RECISTv1.1) definition.

• Desire to undergo autologous reconstruction and assessed to be an appropriate candidate by a plastic and reconstructive surgeon

• Able to read and understand English

Exclusion Criteria:

• Prior ipsilateral breast cancer

• Bilateral breast cancer

• Pregnant

• Stage IV disease at presentation

• Stable disease or progressive disease after NAC

• Surgically unresectable breast disease

• BMI >40

• Prior history of thoracic radiotherapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065

Sponsors and Collaborators

• Memorial Sloan Kettering Cancer Center

Investigators

• Principal Investigator: Audree Tadros, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Memorial Sloan Kettering Cancer Center

Publications

None provided.

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT05412225
• Other Study ID Numbers: 22-136
• First Posted: Jun 9, 2022
• Last Update Posted: Jul 28, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Memorial Sloan Kettering Cancer Center: breast cancer; mastectomy; Memorial Sloan Kettering Cancer Center; 22-136
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Jul 28, 2022