60 Participants Needed

Preoperative Radiotherapy + Mastectomy for Breast Cancer

Recruiting at 6 trial locations
AT
MC
AK
Overseen ByAtif Khan, MD
Age: 18+
Sex: Female
Trial Phase: Phase 1
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is preoperative radiotherapy for breast cancer generally safe for humans?

Preoperative radiotherapy for breast cancer has been shown to be generally safe, with mild side effects that do not require stopping the treatment. However, some patients may experience wound problems, such as infections or fistulas (abnormal connections between organs), which may need antibiotics or additional surgery.12345

How does the treatment of preoperative radiotherapy and mastectomy for breast cancer differ from other treatments?

This treatment is unique because it involves giving radiotherapy before surgery to shrink the tumor, potentially allowing for more effective surgery and better survival rates, unlike the traditional approach where radiotherapy is given after surgery.678910

What data supports the effectiveness of the treatment Preoperative Radiotherapy + Mastectomy for Breast Cancer?

Research suggests that preoperative radiotherapy, when combined with surgery, can help improve control and survival rates in breast cancer patients. Advances in radiotherapy techniques have made it more precise and effective, potentially increasing disease-free and overall survival rates when used before surgery.711121314

Who Is on the Research Team?

AT

Audree Tadros, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I want and am deemed suitable for breast reconstruction using my own tissues.
My tumor is large or has spread to nearby tissues but not to distant parts of the body.
I am a woman over 18 with confirmed invasive breast cancer.
See 2 more

Exclusion Criteria

I have had radiation therapy to my chest area before.
You have a body mass index (BMI) higher than 40.
My breast cancer cannot be removed with surgery.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Chemotherapy

Participants receive standard neoadjuvant chemotherapy to assess response before proceeding to radiotherapy

8-12 weeks

Preoperative Radiotherapy

Participants receive radiotherapy before their mastectomy

4-6 weeks

Surgery and Immediate Reconstruction

Participants undergo mastectomy followed by immediate autologous reconstruction

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on wound complications and surgical outcomes

5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Neoadjuvant radiotherapy
  • Pre-neoadjuvant radiotherapy (NART) biopsy
  • Unilateral total mastectomy with axillary lymph node dissection
Trial Overview 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.
How Is the Trial Designed?
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.

Neoadjuvant radiotherapy is already approved in United States, European Union, China for the following indications:

🇺🇸
Approved in United States as Neoadjuvant radiotherapy for:
  • Locally advanced breast cancer (LABC)
  • T4 breast cancer
🇪🇺
Approved in European Union as Preoperative radiotherapy for:
  • Locally advanced breast cancer (LABC)
  • T4 breast cancer
🇨🇳
Approved in China as Neoadjuvant radiotherapy for:
  • Locally advanced breast cancer (LABC)
  • T4 breast cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Published Research Related to This Trial

The increasing use of neoadjuvant chemotherapy in breast cancer patients with node-positive disease raises questions about the necessity of complete axillary lymph node dissection (ALND) after achieving a complete clinical response, highlighting a need for individualized treatment approaches.
The article emphasizes the importance of ongoing clinical trials to gather more evidence on optimal locoregional management, encouraging patient participation in trials and supporting informed decision-making based on personal values.
Debating the Optimal Approach to Nodal Management After Pathologic Complete Response to Neoadjuvant Chemotherapy in Patients With Breast Cancer.Carter, S., Neuman, H., Mamounas, EP., et al.[2019]
Recent advancements in breast cancer treatment are shifting towards administering systemic therapy before surgery, which can lead to more effective treatment outcomes and potentially higher rates of disease-free and overall survival.
The evolving approach to radiotherapy includes considering its use before surgery, supported by improved radiobiological knowledge and technology, allowing for safer and more effective combinations with other treatments like antitumor drugs or immunotherapy.
Preoperative Radio(Chemo)Therapy in Breast Cancer: Time to Switch the Perspective?Montero, A., Ciérvide, R.[2023]
In a study of 176 node-positive, ER+, HER2- breast cancer patients treated with neoadjuvant therapy, the overall rate of axillary pathologic complete response (pCR) was 12.3%, with higher rates observed in patients diagnosed at clinical stage II (20%) compared to stage III (8.4%).
Neoadjuvant chemotherapy (NCT) was associated with a higher pCR rate (13.9%) compared to neoadjuvant endocrine therapy (NET) (7.3%), and most patients achieving pCR after NCT were able to avoid axillary dissection, highlighting the potential of NAT to reduce surgical interventions.
Axillary Response to Neoadjuvant Therapy in Node-Positive, Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer Patients: Predictors and Oncologic Outcomes.Friedman-Eldar, O., Ozmen, T., El Haddi, SJ., et al.[2022]

Citations

Debating the Optimal Approach to Nodal Management After Pathologic Complete Response to Neoadjuvant Chemotherapy in Patients With Breast Cancer. [2019]
Preoperative Radio(Chemo)Therapy in Breast Cancer: Time to Switch the Perspective? [2023]
Axillary Response to Neoadjuvant Therapy in Node-Positive, Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer Patients: Predictors and Oncologic Outcomes. [2022]
Preoperative or postoperative irradiation as adjunctive treatment with radical mastectomy in breast cancer. [2019]
Management of the clinically positive axilla. [2020]
Breast conservative surgery for operable invasive ductal carcinoma after neoadjuvant chemotherapy or hormonal therapy- a challenge for breast surgeon: a review based on literature and experience. [2014]
Pre-OPerative accelerated radiotherapy for early stage breast cancer patients (POPART): A feasibility study. [2022]
[Preoperative radiotherapy in breast cancer. Description of a clinical trial record and first results]. [2009]
Prospective randomized clinical trial: protoadjuvant chemotherapy vs. protoadjuvant radiotherapy in breast cancer stages T3/4, N+/-, M0. [2007]
10.United Statespubmed.ncbi.nlm.nih.gov
Postmastectomy Radiotherapy: An American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Focused Guideline Update. [2022]
[Morbidity of surgical treatment for advanced cancer of the breast after irradiation]. [2009]
12.United Statespubmed.ncbi.nlm.nih.gov
Primary radiation therapy as an alternative to mastectomy for early-stage breast cancer. [2006]
[Preoperative radiotherapy and curative radiotherapy without mastectomy in carcinoma of the breast (author's transl)]. [2006]
Preoperative breast radiation therapy: Indications and perspectives. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security