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Invasive Ductal Breast CarcinomaPhase 2NCT04084730

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

A Phase 2 study testing Accelerated Partial Breast Irradiation in people with Invasive Ductal Breast Carcinoma and Invasive Ductal Carcinoma, Breast, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 45 years and older, women only
What is being tested?
Accelerated Partial Breast Irradiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
9 sitesUnited States
Study dates
30 Aug 2019to 30 Aug 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female
  • Age >/= 45 years
  • Unicentric pathological stage I (pT1 or T2 pN0_M0) invasive ductal breast cancer or DCIS measuring <3 cm in longest diameter on pathology and/or mammogram that is histologically confirmed. If T2, the tumor must be less than 3cm in longest diameter. Note: Women ≥ 70 years or older with T1 invasive ductal carcinoma who are estrogen- receptor positive (ER+) with clinically negative axillary nodes, and do not undergo surgical lymph node mapping or dissection (i.e., if tumor deposit is 0.2 mm or less, regardless of whether the deposit is detected by immunohistochemistry or hematoxylin and eosin staining) will also be eligible. Patients age 50 or older who are clinically node-negative by physical exam and ultrasound and have a primary tumor that is <=2 cm and hormone-receptor positive, are also eligible.
  • 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 prior to study treatment if a woman has child-bearing potential. Subjects of child bearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year
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  • Written informed consent obtained from subject and ability for subject or comply with the requirements of the study
  • Female subjects of childbearing potential should be willing to use 2 methods or birth control or be surgically sterile or abstain from heterosexual activity for the duration of study participation. Should a woman become pregnant while participating on study, she should inform the treating physician immediately.
  • Post-NAC cohort patients: clinical T1-T2 (less than or equal to 5cm in longest diameter on available imaging) and clinical N0-N1 (on exam and imaging) with pathological ypT0, ypTis, or ypT1 (<=2cm) and ypN0 (any regimen of neoadjuvant chemotherapy agents is allowed)
  • OR
  • Oncotype RS score of 26 or higher
  • OR
  • PAM50 ROR scored as "HIGH"
  • OR
  • Presence or LVI (focal, limited or "not otherwise specified") in the lumpectomy specimen
  • OR
  • Age 40-49 years (ALL OF THE FOLLOWING MUST BE TRUE : 1) no history of prior benign breast biopsies, 2) no concomitant or prior atypia in either breast, 3) no concomitant or prior LCIS in either breast, 4) no family history of breast cancer in first degree relatives)
  • OR
  • Invasive lobular carcinoma
  • OR
  • Surgical margins less than 1 mm to invasive or in-situ disease.

Who cannot join

  • Patients with distant metastasis
  • Patients who are pregnant or breastfeeding
  • Patients with diffuse (>1 quadrant or >5cm) suspicious microcalcifications or patients with known multicentric OR multifocal disease. (microscopic multifocal disease that may be unifocal and/or appear multifocal due to sectioning is allowed after review with PI).
  • Prior radiation therapy to the ipsilateral or contralateral breast or thorax.
  • Histological evidence of extensive lymphovascular invasion (LVI)
  • Histological evidence of extensive intraductal component (EIC), defined as the presence of intraductal carcinoma both within the primary infiltrating ductal tumor (comprising at least 25% of the tumo area) and intraductal carcinoma present clearly beyond the edges of the invasive tumor.
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  • Patients are not required to undergo BRCA1 and BRCA2 or other genetic mutation tests in order to enroll on the study. Note: in the event a patient is tested and is found to be a mutation carrier, she would be excluded from the study. It would be an extremely rare/unlikely scenario for patients to be discovered BRCA positive after the completion of PBI, as all patients with risk factors for BRCA mutations (positive family history, Ashkenazi Jewish descent, ER-/PR-/her2-neu-negative receptor status) are usually tested prior to radiation. Should such a situation exist, these patients will be given the option of remaining on the breast conservation paradigm or opting for mastectomy (as is done in this rare scenario is standard of care practice). The patient will be replaced on the trial.
  • History of cosmetic or reconstructive breast surgery.
  • Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other collagen vascular diseases) that, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
  • Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have "currently active" malignancies if they have completed therapy and are considered by their physicians to be at <5% risk of relapse within 3 years.
  • Patients who are already enrolled in or planning to enroll in other adjuvant systemic therapy protocols for both non-invasive or invasive breast cancer
  • Expecting to conceive within the projected duration of the trials, starting with screening visit through 180 days after the last dose of trial treatment
  • Concomitant anti-neoplastic treatment is not allowed during protocol treatment and should be completed at least 2 weeks prior to commencement of protocol treatment, with resolution of associated acute toxicities. Bisphosponates are permitted without restriction even during protocol treatment. Note: This does not apply to hormonal therapies such as tamoxifen or AIs, which are permitted. This does not apply to anti-Her2 therapies such as trastuzumab or TDM-1, which are also permitted.
  • Ongoing therapy with other investigational agents. Patients may not be receiving any other investigational agents.

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Atif J Khan, MD contact

848-225-6334

khana7@mskcc.org

Simon Powell, MD, PhD contact

212-639-3639

powells@mskcc.org

9 sites in 1 country

United States9 sites, 9 recruiting

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

    Atif J Khan, MD, 848-225-6334

    Recruiting

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

    Atif J Khan, MD, 848-225-6334

    Recruiting

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

    Atif J Khan, MD, 848-225-6334

    Recruiting

  • Baptist Alliance Miami Cancer Institute

    Miami, Florida, 33143

    Joseph Panoff, MD, 786-596-2000

    Recruiting

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

    Atif J Khan, MD, 848-225-6334

    Recruiting

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

    Atif J Khan, MD, 848-225-6334

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

    Atif J Khan, MD, 848-225-6334

    Recruiting

  • Norwalk Hospital

    Norwalk, Connecticut, 06850

    Philip Gilbo, MD, 203-845-4811

    Recruiting

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

    Atif J Khan, MD, 848-225-6334

    Recruiting

Other trials in United States

About this study

Official title: Ultra-Short External Beam-Based Accelerated Partial Breast Irradiation (APBI): A Phase II Toxicity Study Nested With a Non-inferiority Assessment of APBI in New Patient Cohorts

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.

Being tested
Accelerated Partial Breast Irradiation
Keywords
Unicentric pathological stage I breast invasive ductal breast cancer, Breast Cancer, Memorial Sloan Kettering Cancer Center, 19-300
Medical subject headings
Carcinoma, Ductal, Breast, Carcinoma, Intraductal, Noninfiltrating, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Accelerated Partial Breast IrradiationRadiation

    Also called APBI

    Treatment will consist of APBI delivered using external beam RT techniques to a dose of 24 Gy in 3 fractions of 8.0 Gy delivered on consecutive weekdays

Study groups in NCT04084730
Study groupRoleWhat they receive
Participants with Breast CancerExperimentalParticipants 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.
Receives: Radiation: Accelerated Partial Breast Irradiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Toxicity with novel APBI schedule as determined by CTCAE version 5

    The study is deemed too toxic if the rate of serious toxicity is >/= 10%.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2019
  2. Study start30 Aug 2019
  3. Primary completion30 Aug 2027 (estimated)
  4. Study completion30 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04084730
Sponsor's protocol ID
19-300
Status last verified
Sep 2026
First submitted
4 Sep 2019
Last updated
21 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Accelerated Partial Breast Irradiation in people with Invasive Ductal Breast Carcinoma and Invasive Ductal Carcinoma, Breast, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Atif J Khan, MD (848-225-6334, khana7@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Toxicity with novel APBI schedule as determined by CTCAE version 5 (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04084730.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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