Actively Recruiting

Phase 2
Age: 45Years +
FEMALE
NCT04084730

Study of 3-Day Partial Breast Radiation Therapy in Women With Breast Cancer

Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-09-16

280

Participants Needed

9

Research Sites

365 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to determine if the dose of radiation therapy that is effective in producing a treatment response, delivered over a shorter treatment period, is a safe approach that causes few or mild side effects in women with newly diagnosed breast cancer or DCIS who have had a lumpectomy procedure.

CONDITIONS

Official Title

Study of 3-Day Partial Breast Radiation Therapy in Women With Breast Cancer

Who Can Participate

Age: 45Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female
  • Age 45 years or older
  • Unicentric pathological stage I invasive ductal breast cancer or DCIS less than 3 cm confirmed by pathology or mammogram
  • Histologically negative tumor margin or no tumor in a re-excision specimen on final shaved specimen
  • ECOG Performance Status of 0 or 1
  • Negative serum pregnancy test within 14 days before treatment if of child-bearing potential
  • Ability to provide written informed consent and comply with study requirements
  • Female subjects of childbearing potential willing to use two methods of birth control, be surgically sterile, or abstain from heterosexual activity during study participation
  • Intermediate risk substudy includes specific criteria such as post-neoadjuvant chemotherapy status, oncotype RS score 26 or higher, PAM50 ROR high score, presence of lymphovascular invasion, age 40-49 with no history of certain breast conditions or family history, invasive lobular carcinoma, or surgical margins less than 1 mm to invasive or in-situ disease
Not Eligible

You will not qualify if you...

  • Patients with distant metastasis
  • Pregnant or breastfeeding patients
  • Patients with diffuse suspicious microcalcifications or known multicentric or multifocal disease
  • Prior radiation therapy to the ipsilateral or contralateral breast or thorax
  • Histological evidence of extensive lymphovascular invasion
  • Histological evidence of extensive intraductal component (EIC)
  • Known BRCA1 or BRCA2 mutation carriers
  • History of cosmetic or reconstructive breast surgery
  • Medical conditions such as uncontrolled infection, uncontrolled diabetes, or connective tissue diseases deemed hazardous
  • Currently active second malignancy other than non-melanoma skin cancers
  • Enrollment in other adjuvant systemic therapy protocols for breast cancer
  • Expecting to conceive during the study period up to 180 days after last treatment
  • Concurrent anti-neoplastic treatment during protocol treatment except hormonal or anti-Her2 therapies
  • Ongoing therapy with other investigational agents

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 9 locations

1

Norwalk Hospital

Norwalk, Connecticut, United States, 06850

Actively Recruiting

2

Baptist Alliance Miami Cancer Institute

Miami, Florida, United States, 33143

Actively Recruiting

3

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

4

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States, 07748

Actively Recruiting

5

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States, 07645

Actively Recruiting

6

Memorial Sloan Kettering Commack

Commack, New York, United States, 11725

Actively Recruiting

7

Memorial Sloan Kettering Westchester

Harrison, New York, United States, 10604

Actively Recruiting

8

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10021

Actively Recruiting

9

Memorial Sloan Kettering Nassau

Uniondale, New York, United States, 11553

Actively Recruiting

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Research Team

A

Atif J Khan, MD

CONTACT

S

Simon Powell, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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