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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is testing an alternative treatment approach for people with T4 breast cancer that involves giving radiotherapy before their mastectomy and performing immediate reconstruction surgery. The trial is comparing the safety of this alternative approach with the standard treatment approach.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,937 Previous Clinical Trials

588,260 Total Patients Enrolled

202 Trials studying Breast Cancer

81,033 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings available for those wishing to join this medical trial?

"According to the clinicaltrials.gov page, this research trial is actively seeking out subjects, with a start date of June 6th 2022 and an update on November 23rd 2022."

Answered by AI

What is the current participation rate for this medical experiment?

"Right, the clinicaltrials.gov page states that this trial is currently recruiting participants. This research program was opened on June 6th 2022 and recently updated on November 23rd 2022 - 60 volunteers are required from a single medical centre."

Answered by AI

What risks and potential benefits should be taken into account when considering Unilateral total mastectomy with axillary lymph node dissection?

"The safety of Unilateral total mastectomy with axillary lymph node dissection is estimated at a score of 1, as it is currently undergoing Phase 1 testing. This indicates that limited data exists to support efficacy and safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Study of an Alternative Treatment Approach (Preoperative Radiotherapy, Then Mastectomy, Then Immediate Reconstruction Surgery) in People With T4 Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05412225.

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