Recruiting
Phase 1

Preoperative Radiotherapy

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT05412225

Conditions

Breast Cancer

Invasive Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pre-neoadjuvant radiotherapy (NART) biopsy

Neoadjuvant radiotherapy

Unilateral total mastectomy with axillary lymph node dissection

Study Details

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.

Conditions

Breast Cancer

Invasive Breast Cancer

Study ID

NCT05412225

Start date

Jun 6, 2022

Status verified date

Jul, 2026

Completion date

Jun 6, 2027

Anticipated

Primary completion date

Jun 6, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Female sex, aged ≥18 years, with biopsy-proven invasive breast cancer
  • cT3-4 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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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

Neoadjuvant radiotherapy

After biopsy, participants will undergo neoadjuvant radiotherapy/NART

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. All patients will also undergo simultaneous unilateral autologous-based breast reconstruction with DIEP, ms-TRAM, or latissimus dorsi flap.

Primary outcome measure

  • 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 [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Minna Lee, MD

646-888-6898leem15@mskcc.org

Atif Khan, MD

848-225-6334khana7@mskcc.org

Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Minna Lee, MD

646-888-6898

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Minna Lee, MD

646-888-6898

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Minna Lee, MD

646-888-6898

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity)

Recruiting

Commack, New York, United States, 11725

Contacts

Minna Lee, MD

646-888-6898

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Minna Lee, MD

646-888-6898

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Minna Lee, MD

646-888-6898

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Minna Lee, MD

646-888-6898

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • breast cancer
  • mastectomy
  • Memorial Sloan Kettering Cancer Center
  • 22-136

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-07-24.