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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
Must not have
Ongoing therapy with other investigational agents. Patients may not be receiving any other investigational agents.
Patients who are already enrolled in or planning to enroll in other adjuvant systemic therapy protocols for both non-invasive or invasive breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
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 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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My cancer surgery cut very close to the cancer cells.
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My breast cancer risk score is high.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not currently on any experimental treatments.
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I am enrolled or plan to enroll in another treatment study for my breast cancer.
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I have had radiation therapy on the same or opposite side of my chest before.
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I have had cosmetic or reconstructive surgery on my breast.
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My cancer has spread to distant parts of my body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Toxicity with novel APBI schedule as determined by CTCAE version 5
Side effects data
From 2021 Phase 2 trial • 200 Patients • NCT0252649822%
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)
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 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
1,979 Previous Clinical Trials
599,798 Total Patients Enrolled
207 Trials studying Breast Cancer
82,683 Patients Enrolled for Breast Cancer
Atif J Khan, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.My breast cancer surgery showed signs of cancer in the lymph vessels.My breast cancer is of the invasive lobular type.I do not have uncontrolled infections, diabetes, or connective tissue diseases that would make treatment risky.I am not currently on any experimental treatments.The cancer has spread beyond the edges of the main tumor and makes up at least 25% of the tumor area.I do not have an active cancer other than non-melanoma skin cancer, or my doctor believes my relapse risk is below 5% in the next 3 years.I am aged 40-49, with no breast biopsies, atypia, LCIS history, or family history of breast cancer.Clips were placed in my surgery area to help guide future treatments.I have not been tested for BRCA mutations, or if tested, I am not a carrier.I am enrolled or plan to enroll in another treatment study for my breast cancer.I have had radiation therapy on the same or opposite side of my chest before.There is a lot of evidence showing that the cancer has spread through the lymph vessels.I have had cosmetic or reconstructive surgery on my breast.My breast cancer is in an early stage, not spread, and the tumor is smaller than 3cm.I am female.My breast cancer is widespread or in multiple areas.My cancer has spread to distant parts of my body.My Oncotype DX breast cancer test score is 26 or higher.I am 45 years old or older.I haven't had cancer treatments other than bisphosphonates, hormonal therapies, or anti-HER2 therapies in the last 2 weeks.My final surgery samples show no cancer at the edges or no cancer at all.I am using two birth control methods or am not able to have children, and will inform my doctor if I become pregnant.My cancer surgery cut very close to the cancer cells.I am not pregnant and can become pregnant but have taken a test confirming this within the last 14 days.My breast cancer was small (<=5cm) before treatment and no cancer in lymph nodes after.My breast cancer risk score is high.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with Breast Cancer
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Breast Cancer Patient Testimony for trial: Trial Name: NCT04084730 — Phase 2