Invasive Ductal Breast CarcinomaNCT05837767
A Study of Radiation Therapy to Treat Solid Tumor Cancer That Has Spread to Soft Tissue
A study testing Palliative radiotherapy in people with Invasive Ductal Breast Carcinoma and Invasive Ductal Breast Carcinoma Stage IV, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of this study is to find out whether lattice radiation therapy (LRT) is an effective radiation therapy technique when compared to standard stereotactic body radiation therapy (SBRT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Ductal Breast Carcinoma, Invasive Ductal Breast Carcinoma Stage IV, Lobular Breast Carcinoma
- What is being tested?
- Palliative radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 7 sitesUnited States
- Study dates
- 24 Jul 2023to 24 Jul 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with biopsy confirmed advanced/metastatic solid tumors of the following types: invasive ductal or lobular breast carcinoma (all histological and intrinsic subtypes), non-small cell lung cancer (NSCLC, all subtypes), gastrointestinal squamous cell or adenocarcinomas (including pancreatic cancer), bladder cancer, renal cell carcinoma, melanoma, and soft tissue sarcoma (all subtypes), who require and are being planned for palliative radiation therapy to at least one site of extracranial metastatic disease measuring at least 5 cm in a single axis. If a patient, requires palliative radiotherapy to additional sites, these can be treated with standard of care SBRT per departmental guidelines.
- Age ≥ 18 years
- ECOG Performance Status of 0 or 1.
Who cannot join
- Patients who are pregnant or breastfeeding
- Prior radiation therapy to the candidate metastatic sites under consideration for treatment ("re-irradiation" is disallowed).
- 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" metastatic second malignancy.
- Patients on oral or parental corticosteroids. Physiological doses of steroids are permitted (eg for patients with adrenal insufficiency). If patients are on supraphysiological doses of steroids, these must be discontinued and held during the period of the study.
- Concomitant anti-neoplastic treatment is not allowed during the days of radiation treatment delivery and should be completed or held for 3 days prior to commencement of protocol treatment and for 3 days following completion of radiotherapy, or with resolution of associated acute toxicities.
- Unwilling or unable to participate in all required study evaluations and procedures.
- Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local patient privacy regulations).
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Atif Khan, MD, 848-225-6334
- Recruiting
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
Commack, New York, 11725
Atif Khan, MD, 848-225-6334
- Recruiting
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Atif Khan, MD, 848-225-6334
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Atif Khan, MD, 848-225-6334
- Recruiting
Memorial Sloan Kettering Bergen (Limited protocol activities)
Montvale, New Jersey, 07645
Atif Khan, MD, 848-225-6334
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Atif Khan, MD, 848-225-6334
- Recruiting
Memorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, New York, 11553
Atif Khan, MD, 848-225-6334
About this study
Official title: A Pilot Study of Spatially Fractionated Radiation Therapy in Patients With Extra-Cranial Soft Tissue Metastases
The purpose of this study is to find out whether lattice radiation therapy (LRT) is an effective radiation therapy technique when compared to standard stereotactic body radiation therapy (SBRT). The study will also study how the different radiation therapy techniques (LRT and SBRT) affect how many immune cells are able to attack and kill tumor cells (immune infiltration).
- Conditions
- Invasive Ductal Breast Carcinoma, Invasive Ductal Breast Carcinoma Stage IV, Lobular Breast Carcinoma, Lobular Breast Carcinoma Stage IV, Non Small Cell Lung Cancer, NSCLC
- Being tested
- Palliative radiotherapy
- Keywords
- Invasive Ductal Breast Carcinoma, Lobular Breast Carcinoma, Non Small Cell Lung Cancer, NSCLC, Gastrointestinal Cancer, Gastrointestinal Squamous Cell Cancer, Pancreatic Cancer, Bladder Cancer, Renal Cell Carcinoma, Melanoma, Sarcoma, Metastatic Solid Tumor, extra-cranial disease, lattice radiation therapy, LRT, spatially fractionated radiation therapy, SFRT, SBRT, stereotactic body radiation therapy, 22-207
- Medical subject headings
- Carcinoma, Ductal, Breast, Carcinoma, Lobular, Carcinoma, Non-Small-Cell Lung, Gastrointestinal Neoplasms, Pancreatic Neoplasms, Urinary Bladder Neoplasms, Carcinoma, Renal Cell, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative radiotherapyRadiation
Palliative radiotherapy (RT) will be performed using external beam ionizing radiation in accordance with standard practice
| Study group | Role | What they receive |
|---|---|---|
| Participants with metastatic solid tumors | Experimental | Participants will have metastatic solid tumors and at least two sites of measurable extra-cranial disease Receives: Radiation: Palliative radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
The primary endpoint is ORR in the LRT-treated lesion, as defined by RECIST v.1.1 criteria, at 12 weeks on a standard-of-care response assessment CT or F-18-FDG PET/CT scan after LRT.
Measured: 12 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start24 Jul 2023
- Primary completion24 Jul 2027 (estimated)
- Study completion24 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Ductal Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems
- Responsible party
- Sponsor
- Investigators
- Atif Khan, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837767
- Sponsor's protocol ID
- 22-207
- Status last verified
- Sep 2026
- First submitted
- 20 Apr 2023
- Last updated
- 2 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Spatially Fractionated Radiation Therapy in Patients With Extra-Cranial Soft Tissue Metastases
- ClinicalTrials.gov ID
- NCT05837767
- Acronym / sponsor ID
- 22-207
- Conditions
- Invasive Ductal Breast Carcinoma, Invasive Ductal Breast Carcinoma Stage IV, Lobular Breast Carcinoma, Lobular Breast Carcinoma Stage IV, Non Small Cell Lung Cancer, NSCLC
- Keywords
- Invasive Ductal Breast Carcinoma, Lobular Breast Carcinoma, Non Small Cell Lung Cancer, NSCLC, Gastrointestinal Cancer, Gastrointestinal Squamous Cell Cancer, Pancreatic Cancer, Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Varian Medical Systems
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 24 Jul 2027 (estimated)
- Study completion
- 24 Jul 2027 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out whether lattice radiation therapy (LRT) is an effective radiation therapy technique when compared to standard stereotactic body radiation therapy (SBRT). The study will also study how the different radiation therapy techniques (LRT and SBRT) affect how many immune cells are able to attack and kill tumor cells (immune infiltration).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with metastatic solid tumors | Experimental | Radiation: Palliative radiotherapyParticipants will have metastatic solid tumors and at least two sites of measurable extra-cranial disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with biopsy confirmed advanced/metastatic solid tumors of the following types: invasive ductal or lobular breast carcinoma (all histological and intrinsic subtypes), non-small cell lung cancer (NSCLC, all subtypes), gastrointestinal squamous cell or adenocarcinomas (including pancreatic cancer), bladder cancer, renal cell carcinoma, melanoma, and soft tissue sarcoma (all subtypes), who require and are being planned for palliative radiation therapy to at least one site of extracranial metastatic disease measuring at least 5 cm in a single axis. If a patient, requires palliative radiotherapy to additional sites, these can be treated with standard of care SBRT per departmental guidelines.
- Age ≥ 18 years
- ECOG Performance Status of 0 or 1.
Key exclusion criteria (8 listed)
- Patients who are pregnant or breastfeeding
- Prior radiation therapy to the candidate metastatic sites under consideration for treatment ("re-irradiation" is disallowed).
- 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" metastatic second malignancy.
- Patients on oral or parental corticosteroids. Physiological doses of steroids are permitted (eg for patients with adrenal insufficiency). If patients are on supraphysiological doses of steroids, these must be discontinued and held during the period of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palliative radiotherapyPalliative radiotherapy (RT) will be performed using external beam ionizing radiation in accordance with standard practice | Radiation | Participants with metastatic solid tumors |
Primary outcome
Overall Response Rate (ORR)
Time frame: 12 weeks from baseline
The primary endpoint is ORR in the LRT-treated lesion, as defined by RECIST v.1.1 criteria, at 12 weeks on a standard-of-care response assessment CT or F-18-FDG PET/CT scan after LRT.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Atif Khan, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palliative radiotherapy in people with Invasive Ductal Breast Carcinoma and Invasive Ductal Breast Carcinoma Stage IV, run by Memorial Sloan Kettering Cancer Center at 7 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 3 inclusion and 8 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 2 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 7 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.
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 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?
Overall Response Rate (ORR) (time frame: 12 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2026.