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Radiation

Preoperative Radiotherapy + Mastectomy for Breast Cancer

Phase 1
Recruiting
Led By Audree Tadros, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
cT3-4 cN0-3 tumor
Female sex, aged ≥18 years, with biopsy-proven invasive breast cancer
Must not have
Prior history of thoracic radiotherapy
Surgically unresectable breast disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new treatment for people with advanced breast cancer. It uses radiation to shrink the tumor before surgery and then rebuilds the breast using tissue from another part of the body. The goal is to see if this approach is safe and practical compared to standard treatments.

Who is the study for?
This trial is for women over 18 with invasive breast cancer at a specific stage (cT3-4 cN0-3). They should have responded to initial chemotherapy, want reconstruction surgery using their own tissue, and be able to read English. It's not for those with unresectable disease, bilateral or previous same-side breast cancer, pregnancy, no change or worsening after chemo, prior chest radiotherapy, or BMI over 40.
What is being tested?
The study tests preoperative radiotherapy followed by mastectomy and immediate autologous reconstruction in T4 breast cancer patients. This means radiation treatment before surgery and using the patient's own tissue for breast reconstruction right after removing the cancer.
What are the potential side effects?
Potential side effects may include skin changes from radiotherapy like redness or peeling; surgical risks such as infection; pain; swelling; complications from anesthesia; and issues related to tissue transfer for reconstruction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor is large or has spread to nearby tissues but not to distant parts of the body.
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I am a woman over 18 with confirmed invasive breast cancer.
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My cancer responded to initial chemotherapy, as shown by scans and exams.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had radiation therapy to my chest area before.
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My breast cancer cannot be removed with surgery.
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I have cancer in both of my breasts.
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I have had breast cancer in the same breast before.
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My cancer did not improve or got worse after chemotherapy before surgery.
Select...
My condition was diagnosed at stage IV.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants with clinical T4 biopsy-proven breast cancerExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neoadjuvant radiotherapy
2016
Completed Early Phase 1
~90

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Preoperative radiotherapy uses high-energy radiation to shrink the tumor before surgery, making the tumor easier to remove and potentially allowing for less extensive surgery. Immediate autologous reconstruction involves using the patient's own tissue to reconstruct the breast immediately after mastectomy, which can provide better cosmetic results and improve psychological well-being. These treatments are significant for breast cancer patients as they can enhance surgical outcomes, reduce the need for multiple surgeries, and improve overall quality of life.
Abbreviated course of radiotherapy (RT) for breast cancer.[Radiation therapy after mastectomy--interdisciplinary consensus puts and end to a controversy. German Society of Senology].

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,973 Previous Clinical Trials
597,678 Total Patients Enrolled
206 Trials studying Breast Cancer
82,263 Patients Enrolled for Breast Cancer
Audree Tadros, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Neoadjuvant radiotherapy (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT05412225 — Phase 1
Breast Cancer Research Study Groups: Participants with clinical T4 biopsy-proven breast cancer
Breast Cancer Clinical Trial 2023: Neoadjuvant radiotherapy Highlights & Side Effects. Trial Name: NCT05412225 — Phase 1
Neoadjuvant radiotherapy (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05412225 — Phase 1
~10 spots leftby Jun 2025