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Radiation Therapy

3-Day Partial Breast Radiation for Breast Cancer

Phase 2
Recruiting
Led By Atif J Khan, 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
ECOG Performance Status of 0 or 1.
Presence or LVI (focal, limited or "not otherwise specified") in the lumpectomy specimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing if a higher does of radiation given over a shorter period is just as effective and has fewer side effects than the standard lower does given over a longer period.

Who is the study for?
This trial is for women aged 45 or older with early-stage breast cancer (stage I) or DCIS, who have had a lumpectomy. They must not be pregnant, breastfeeding, or at high risk of pregnancy without using contraception. Women under 70 with certain types of small tumors and no severe lymph invasion are eligible. Those with distant metastasis, prior chest radiation, active second malignancy other than non-melanoma skin cancers, or on investigational drugs are excluded.Check my eligibility
What is being tested?
The study tests if a concentrated dose of radiation therapy over three days is effective and safe for women after lumpectomy for breast cancer/DCIS. It aims to see if this shorter treatment period results in few or mild side effects compared to traditional longer treatments.See study design
What are the potential side effects?
Potential side effects from the accelerated partial breast irradiation may include skin changes like redness and irritation around the treated area, fatigue, discomfort in the breast tissue, and rare risks associated with radiation such as changes in breast shape.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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My breast cancer surgery showed signs of cancer in the lymph vessels.
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My breast cancer is of the invasive lobular type.
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I am aged 40-49, with no breast biopsies, atypia, LCIS history, or family history of breast cancer.
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Clips were placed in my surgery area to help guide future treatments.
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My breast cancer is in an early stage, not spread, and the tumor is smaller than 3cm.
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I am female.
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I am female.
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My Oncotype DX breast cancer test score is 26 or higher.
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I am 45 years old or older.
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My final surgery samples show no cancer at the edges or no cancer at all.
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I am using two birth control methods or am not able to have children, and will inform my doctor if I become pregnant.
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My cancer surgery cut very close to the cancer cells.
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I am not pregnant and can become pregnant but have taken a test confirming this within the last 14 days.
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My breast cancer was small (<=5cm) before treatment and no cancer in lymph nodes after.
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My breast cancer risk score is high.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Toxicity with novel APBI schedule as determined by CTCAE version 5

Side effects data

From 2021 Phase 2 trial • 200 Patients • NCT02526498
22%
Musculoskeletal and connective tissue disorders
20%
Injury, poisoning and procedural complications
18%
Reproductive system and breast disorder
15%
Breast Pain
14%
Fibrosis deep connective tissue
14%
Dermatitis radiation
10%
Superficial soft tissue fibrosis
6%
Seroma
5%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (APBI Using HDR Brachytherapy)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants with Breast CancerExperimental Treatment1 Intervention
Participants will have unicentric pathological stage I invasive ductal breast cancer or Grade 1 or 2 DCIS measuring <3cm in longest diameter on pathology and/or mammogram that is histologically confirmed at MSKCC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Accelerated Partial Breast Irradiation
2015
Completed Phase 2
~200

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,930 Previous Clinical Trials
596,978 Total Patients Enrolled
Atif J Khan, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Accelerated Partial Breast Irradiation (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04084730 — Phase 2
Ductal Carcinoma In Situ Research Study Groups: Participants with Breast Cancer
Ductal Carcinoma In Situ Clinical Trial 2023: Accelerated Partial Breast Irradiation Highlights & Side Effects. Trial Name: NCT04084730 — Phase 2
Accelerated Partial Breast Irradiation (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04084730 — Phase 2
Ductal Carcinoma In Situ Patient Testimony for trial: Trial Name: NCT04084730 — Phase 2

Frequently Asked Questions

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

What is the current capacity of this clinical trial's participant pool?

"Affirmative. According to the data hosted on clinicaltrials.gov, this medical study is presently recruiting participants. The trial was initially posted in August 2019 and updated lastly in October 2022; it requires 140 subjects from 12 sites for successful completion of the project."

Answered by AI

How many sites are in charge of managing this research endeavor?

"Through the course of this medical trial, 12 different hospitals are participating. These include Memorial Sloan Kettering Basking Ridge in Basking Ridge and two Memoral Sloan Kettering Monmouth locations (Middletown & Uniondale), as well as other healthcare institutions."

Answered by AI

Has the FDA given clearance for Accelerated Partial Breast Irradiation?

"Our team at Power assessed the safety of Accelerated Partial Breast Irradiation to be a 2, as this is still in Phase 2. This means that while there have been some data showing safety, efficacy has yet to be conclusively proven."

Answered by AI

Are there any vacancies remaining for the trial?

"The information hosted on clinicaltrials.gov indicates this trial is currently in need of enrollees, with the first posting date being August 30th 2019 and a recent update occuring October 4th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
What site did they apply to?
Memoral Sloan Kettering Basking Ridge
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I am trying to avoid traditional standard of care treatment which has been recommended to me.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How soon can treatment begin?
PatientReceived no prior treatments
~33 spots leftby Aug 2024