- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04084730
Study of 3-Day Partial Breast Radiation Therapy in Women With Breast Cancer
June 14, 2023 updated by: Memorial Sloan Kettering Cancer Center
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
400
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Atif J Khan, MD
- Phone Number: 848-225-6334
- Email: khana7@mskcc.org
Study Contact Backup
- Name: Simon Powell, MD, PhD
- Phone Number: 212-639-3639
- Email: powells@mskcc.org
Study Locations
-
-
Connecticut
-
Norwalk, Connecticut, United States, 06850
- Recruiting
- Norwalk Hospital
-
Contact:
- Philip Gilbo, MD
- Phone Number: 203-845-4811
-
-
Florida
-
Miami, Florida, United States, 33143
- Recruiting
- Baptist Alliance Miami Cancer Institute
-
Contact:
- Joseph Panoff, MD
- Phone Number: 786-596-2000
-
-
New Jersey
-
Basking Ridge, New Jersey, United States, 07920
- Recruiting
- Memorial Sloan Kettering Basking Ridge
-
Contact:
- Atif J Khan, MD
- Phone Number: 848-225-6334
-
Middletown, New Jersey, United States, 07748
- Recruiting
- Memorial Sloan Kettering Monmouth
-
Contact:
- Atif J Khan, MD
- Phone Number: 848-225-6334
-
Montvale, New Jersey, United States, 07645
- Recruiting
- Memorial Sloan Kettering Bergen
-
Contact:
- Atif J Khan, MD
- Phone Number: 848-225-6334
-
-
New York
-
Commack, New York, United States, 11725
- Recruiting
- Memorial Sloan Kettering Commack
-
Contact:
- Atif J Khan, MD
- Phone Number: 848-225-6334
-
Harrison, New York, United States, 10604
- Recruiting
- Memorial Sloan Kettering Westchester
-
Contact:
- Atif J Khan, MD
- Phone Number: 848-225-6334
-
New York, New York, United States, 10021
- Recruiting
- Memorial Sloan Kettering Cancer Center
-
Contact:
- Atif J Khan, MD
- Phone Number: 848-225-6334
-
Uniondale, New York, United States, 11553
- Recruiting
- Memorial Sloan Kettering Nassau
-
Contact:
- Atif J Khan, MD
- Phone Number: 848-225-6334
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
- Histologically negative tumor margin or no tumor in a re-excision specimen on final shaved specimen.
- ECOG Performance Status of 0 or 1.
- Clips must be placed in the lumpectomy cavity at the time of final excision in order to aid in the delineation of the tumor cavity at the time of simulation and radiation delivery.
- 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
- 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.
Inclusion Criteria for intermediate risk substudy:
- Post-NAC cohort patients: clinical T1 or T2 (less than or equal to 5cm in longest diameter on available imaging) and clinical N0 (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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Participants with Breast Cancer
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 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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Toxicity with novel APBI schedule as determined by CTCAE version 5
Time Frame: 24 months
|
The study is deemed too toxic if the rate of serious toxicity is >/= 10%.
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Atif J Khan, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 30, 2019
Primary Completion (Estimated)
August 30, 2024
Study Completion (Estimated)
August 30, 2024
Study Registration Dates
First Submitted
September 4, 2019
First Submitted That Met QC Criteria
September 9, 2019
First Posted (Actual)
September 10, 2019
Study Record Updates
Last Update Posted (Actual)
June 15, 2023
Last Update Submitted That Met QC Criteria
June 14, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-300
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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