What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as preoperative radiotherapy and immediate autologous reconstruction, have several known side effects. Radiotherapy can cause skin irritation, fatigue, and a slight increase in the risk of a second cancer. Surgical procedures, including mastectomy and immediate autologous reconstruction, can lead to complications such as infection, bleeding, and donor site issues. Long-term complications may include lymphedema, reduced shoulder mobility, and changes in breast sensation.

What prior FDA approvals exist?

The FDA has approved various treatments for breast cancer, including those involving preoperative radiotherapy to shrink tumors before surgery. This approach is often used to make surgical resection more effective and to increase the likelihood of a successful outcome. Immediate autologous reconstruction, where the breast is reconstructed using the patient's own tissue immediately after mastectomy, is a surgical option that has been increasingly adopted. While specific drugs for preoperative radiotherapy are not highlighted, the general approach of using radiation to manage tumor size before surgery is well-established in clinical practice.

What other types of research exist?

Promising alternatives to preoperative radiotherapy include neoadjuvant chemotherapy and targeted therapies, which can effectively shrink tumors before surgery. For reconstruction, novel techniques such as oncoplastic surgery, which combines tumor removal with plastic surgery techniques, and the use of advanced biomaterials for reconstruction, offer promising outcomes. Additionally, immediate lymphatic reconstruction to prevent lymphedema is an emerging option that can be considered.

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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.

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My condition was diagnosed at stage IV.

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

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

0 / 9Eligibility criteria met

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].