Triple Negative Breast CancerPhase 2NCT03808337
Investigating the Effectiveness of Stereotactic Body Radiotherapy (SBRT) in Addition to Standard of Care Treatment for Cancer That Has Spread Beyond the Original Site of Disease
A Phase 2 study testing Stereotactic Body Radiotherapy/SBRT in people with Triple Negative Breast Cancer and Non Small Cell Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 12 sites in United States.
Trial summary
This study is being done to determine if stereotactic body radiotherapy (SBRT) when delivered to all sites of disease in participants with 1-5 metastases will increase the length of time before participants' disease gets worse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer, Non Small Cell Lung Cancer, Metastatic Breast Cancer
- What is being tested?
- Stereotactic Body Radiotherapy/SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 12 sitesUnited States
- Study dates
- 16 Jan 2019to Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic disease detected on imaging and histologically confirmed
- Metastatic breast cancer (all subtypes)
- Non-small cell lung cancer (NSCLC) without known targetable molecular alterations in EGFR, ALK, or ROS1
- NSCLC with EGFR, ALK, or ROS1 targetable molecular alterations who had a history of disease progression on first-line tyrosine kinase inhibitor
- Patient can either have newly diagnosed metastatic disease, or have non-progressive disease on systemic therapy (for at least 3 months on systemic imaging)
- Patients must have measurable disease at baseline (RECIST or PERCIST 2.0) and with 5 or fewer discrete disease sites that are technically amendable to SBRT (with the exception that if the primary disease is not amendable to SBRT it is allowed to be treated with conventionally fractionated or hypfractionated radiotherapy).
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- Two lesions in such close proximity to one another that treatment with one isocenter is more accurate and safer in the liver, lungs, or other similar anatomic locations should be viewed as one site of metastatic disease treatment
- Disease in 2 contiguous vertebral bodies (with up to 6 cm of paraspinal extension) can represent one site of disease in the spine; non-contiguous lesions in vertebral bodies separated by one vertebral body free of disease should be viewed as 2 sites of treatment
- If the clinical scenario deem that other forms of local therapy may be more suitable for the metastatic disease, such as surgical resection and interventional radiology-guided ablation, patients would be able to undergo other forms of local therapy with discussion with the PI.
- For de novo stage IV patients (patients with metastatic disease at first presentation), primary disease must be treatable with local therapy. If the primary tumor or other locoregional disease has not been definitively treated and is not amendable to SBRT, it must be treated with conventionally fractionated or hypofractionated radiotherapy using a regimen that delivers a minimum BED of 48 Gy10. If the clinical scenario deem that other forms of local therapy may be more suitable for the primary and locoregional disease, such as surgical resection and interventional radiology-guided ablation, patients would be able to undergo other forms of local therapy with discussion with the PI.
- If primary disease was previously treated with local therapy in the form of surgery or radiation, any new local/regional disease recurrence should be technically treatable with SBRT or hypofractionated radiation. If the clinical scenario deem that other forms of local therapy may be more suitable for the local/regional recurrent disease, such as surgical resection and interventional radiology-guided ablation, patients would be able to undergo other forms of local therapy with discussion with the PI.
- Patients may receive palliative radiotherapy for symptomatic metastases or primary disease prior to enrollment provided that there is at least one other non-irradiated lesion amenable to SBRT at the time of enrollment.
- Patients with brain metastases are eligible if these lesions have been treated prior to enrollment.
- ECOG Performance status 0 - 2.
- Age >/= 18 years.
- Able to provide informed consent.
- Female subjects must either be of non-reproductive potential (i.e. post-menopausal by history: >/= 60 years old or no menses for 1> year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test within 2 weeks prior to starting treatment.
- Adequate baseline organ function to allow SBRT to all relevant targets, as determined by the treating radiation oncologist based on lesion location, lesion size, and proximity to relevant organs at risk.
Who cannot join
- Serious medical co-morbidities precluding radiotherapy, determined at the discretion of the treating investigator.
- Pregnant or lactating women.
- Other active malignancy within the last year, even if without evidence of disease.
- Clinical or radiological evidence of spinal cord compression
- Malignant pleural effusion or ascites.
- Patients whose entry to the trial will cause unacceptable clinical delays in their planned management.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Alyson McIntosh, MD, 610-402-0700
- Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Amy Xu, MD, PhD, 646-888-6863
- Recruiting
Memorial Sloan Kettering Cancer Center @ Commack
Commack, New York, 11725
Amy Xu, MD, PhD, 646-888-6863
- Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Amy Xu, MD, PhD, 646-888-6863
- Recruiting
Hartford Healthcare
Hartford, Connecticut, 06102
Charles Rutter, MD, 860-972-2803
- Recruiting
Baptist Alliance - McI
Miami, Florida, 33143
Rupesh Kotecha, MD, 786-596-2000
- Recruiting
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Amy Xu, MD, PhD, 646-888-6863
- Recruiting
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Amy Xu, MD, PhD, 646-888-6863
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Amy Xu, MD, PhD, 646-888-6863
- Recruiting
WCHN Norwalk Hospital - Data Collection
Norwalk, Connecticut, 06850
Philip Gilbo, MD, 203-221-0059
- Not yet recruiting
Natera, Inc. (Data and Specimen Analysis Only)
San Carlos, California, 94070
Alexey Aleshin, MD, MBA, 650-489-9050
- Recruiting
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
Amy Xu, MD, PhD, 646-888-6863
About this study
Official title: PROMISE-005: A Phase II Randomized Study Assessing the Efficacy of Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Breast or Lung Cancer
This study is being done to determine if stereotactic body radiotherapy (SBRT) when delivered to all sites of disease in participants with 1-5 metastases will increase the length of time before participants' disease gets worse.
- Conditions
- Triple Negative Breast Cancer, Non Small Cell Lung Cancer, Metastatic Breast Cancer, Metastatic Non-Small Cell Lung Carcinoma
- Being tested
- Stereotactic Body Radiotherapy/SBRT, Systemic Therapy/Standard of Care
- Keywords
- Stereotactic body radiotherapy, SBRT, 18-486, Memorial Sloan Kettering Cancer Center
- Medical subject headings
- Triple Negative Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiotherapy/SBRTRadiation
Radiation to each metastatic site should be delivered to a minimum dose of 30 Gy in 5 fractions (BED of 48 Gy10). The exact dose of radiotherapy will be determined by the treating radiation oncologist. Preferred regimens for lung metastases include 50 Gy in five fractions, 48 Gy in four fractions, or 54 Gy in three fractions, although lower doses may be employed to respect dose limits to critical structures such as the esophagus. Recommended SBRT dosing for other sites includes 27 to 30 Gy in three fractions or 24 Gy in one fraction for bone metastases.
Systemic Therapy/Standard of CareDrug
Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating oncologist. For patients randomized to receive SBRT, systemic therapy can be continued during SBRT at the discretion and concensus of treating physicians (medical oncologist and radiation oncologist). If the treating physicians recommend discontinuing systemic therapy during SBRT, general guidelines for stopping and reinitiating systemic regimen are as follows: Hormonal therapies and immunotherapy can be continued during SBRT. Consideration can be given to holding cytotoxic chemotherapy beginning 3 to 7 days prior to the initiation of SBRT until 3 to 7 days after the completion of SBRT. Similarly, consideration can be given to holding biologic agents during SBRT and for 0 to 3 days before and after.
| Study group | Role | What they receive |
|---|---|---|
| Standare of Care | Active comparator | Patients with newly diagnosed metastatic non-small cell lung cancer or triple negative breast cancer may be enrolled on protocol prior to receiving any systemic therapy. If these patients are randomized to the standard of care arm (Arm 1), they will initiate appropriate therapy as determined by their oncologist. Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating oncologist. Receives: Drug: Systemic Therapy/Standard of Care |
| Stereotactic Body Radiotherapy (SBRT) + Standard of Care | Experimental | Patients enrolled on Arm 2 of the study will undergo Stereotactic Body Radiotherapy/SBRT to all known metastases seen on imaging studies performed prior to enrollment. Radiotherapy will be given concurrently to all metastatic sites. Minimum BED for ablative SBRT is more than or equal to 48 Gy10. Patients can undergo systemic therapy concurrently with SBRT at the discretion of treating radiation oncologist and medical oncologist. After completion of SBRT to all sites of known metastatic disease, patients will continue standard of care therapy per the treating oncologist. Receives: Radiation: Stereotactic Body Radiotherapy/SBRT; Drug: Systemic Therapy/Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
To determine whether stereotactic body radiotherapy to all sites of metastatic disease in patients with oligometastatic non-small cell lung cancer or triple-negative breast cancer improves progression free survival (PFS), defined as time from randomization to disease progression or death, as compared to standard of care therapy alone.
Measured: Up to 2 years
Secondary outcomes (1)
Overall Survival
To compare overall survival (OS) between standard of care and SBRT arms.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start16 Jan 2019
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy Xu, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808337
- Sponsor's protocol ID
- 18-486
- Status last verified
- Feb 2026
- First submitted
- 16 Jan 2019
- Last updated
- 27 Feb 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROMISE-005: A Phase II Randomized Study Assessing the Efficacy of Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Breast or Lung Cancer
- ClinicalTrials.gov ID
- NCT03808337
- Acronym / sponsor ID
- 18-486
- Conditions
- Triple Negative Breast Cancer, Non Small Cell Lung Cancer, Metastatic Breast Cancer, Metastatic Non-Small Cell Lung Carcinoma
- Keywords
- Stereotactic body radiotherapy, SBRT, 18-486, Memorial Sloan Kettering Cancer Center
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 17 Jan 2019 (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.
This study is being done to determine if stereotactic body radiotherapy (SBRT) when delivered to all sites of disease in participants with 1-5 metastases will increase the length of time before participants' disease gets worse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standare of Care | Active comparator | Drug: Systemic Therapy/Standard of CarePatients with newly diagnosed metastatic non-small cell lung cancer or triple negative breast cancer may be enrolled on protocol prior to receiving any systemic therapy. If these patients are randomized to the standard of care arm (Arm 1), they will initiate appropriate therapy as determined by their oncologist. Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating oncologist. |
| Stereotactic Body Radiotherapy (SBRT) + Standard of Care | Experimental | Radiation: Stereotactic Body Radiotherapy/SBRT, Drug: Systemic Therapy/Standard of CarePatients enrolled on Arm 2 of the study will undergo Stereotactic Body Radiotherapy/SBRT to all known metastases seen on imaging studies performed prior to enrollment. Radiotherapy will be given concurrently to all metastatic sites. Minimum BED for ablative SBRT is more than or equal to 48 Gy10. Patients can undergo systemic therapy concurrently with SBRT at the discretion of treating radiation oncologist and medical oncologist. After completion of SBRT to all sites of known metastatic disease, patients will continue standard of care therapy per the treating oncologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Metastatic disease detected on imaging and histologically confirmed
- Patient can either have newly diagnosed metastatic disease, or have non-progressive disease on systemic therapy (for at least 3 months on systemic imaging)
- Patients must have measurable disease at baseline (RECIST or PERCIST 2.0) and with 5 or fewer discrete disease sites that are technically amendable to SBRT (with the exception that if the primary disease is not amendable to SBRT it is allowed to be treated with conventionally fractionated or hypfractionated radiotherapy).
- For de novo stage IV patients (patients with metastatic disease at first presentation), primary disease must be treatable with local therapy. If the primary tumor or other locoregional disease has not been definitively treated and is not amendable to SBRT, it must be treated with conventionally fractionated or hypofractionated radiotherapy using a regimen that delivers a minimum BED of 48 Gy10. If the clinical scenario deem that other forms of local therapy may be more suitable for the primary and locoregional disease, such as surgical resection and interventional radiology-guided ablation, patients would be able to undergo other forms of local therapy with discussion with the PI.
- If primary disease was previously treated with local therapy in the form of surgery or radiation, any new local/regional disease recurrence should be technically treatable with SBRT or hypofractionated radiation. If the clinical scenario deem that other forms of local therapy may be more suitable for the local/regional recurrent disease, such as surgical resection and interventional radiology-guided ablation, patients would be able to undergo other forms of local therapy with discussion with the PI.
Key exclusion criteria (6 listed)
- Serious medical co-morbidities precluding radiotherapy, determined at the discretion of the treating investigator.
- Pregnant or lactating women.
- Other active malignancy within the last year, even if without evidence of disease.
- Clinical or radiological evidence of spinal cord compression
- Malignant pleural effusion or ascites.
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 |
|---|---|---|
| Stereotactic Body Radiotherapy/SBRTRadiation to each metastatic site should be delivered to a minimum dose of 30 Gy in 5 fractions (BED of 48 Gy10). The exact dose of radiotherapy will be determined by the treating radiation oncologist. Preferred regimens for lung metastases include 50 Gy in five fractions, 48 Gy in four fractions, or 54 Gy in three fractions, although lower doses may be employed to respect dose limits to critical structures such as the esophagus. Recommended SBRT dosing for other sites includes 27 to 30 Gy in three fractions or 24 Gy in one fraction for bone metastases. | Radiation | Stereotactic Body Radiotherapy (SBRT) + Standard of Care |
| Systemic Therapy/Standard of CareStandard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating oncologist. For patients randomized to receive SBRT, systemic therapy can be continued during SBRT at the discretion and concensus of treating physicians (medical oncologist and radiation oncologist). If the treating physicians recommend discontinuing systemic therapy during SBRT, general guidelines for stopping and reinitiating systemic regimen are as follows: Hormonal therapies and immunotherapy can be continued during SBRT. Consideration can be given to holding cytotoxic chemotherapy beginning 3 to 7 days prior to the initiation of SBRT until 3 to 7 days after the completion of SBRT. Similarly, consideration can be given to holding biologic agents during SBRT and for 0 to 3 days before and after. | Drug | Standare of Care, Stereotactic Body Radiotherapy (SBRT) + Standard of Care |
Primary outcome
Progression Free Survival
Time frame: Up to 2 years
To determine whether stereotactic body radiotherapy to all sites of metastatic disease in patients with oligometastatic non-small cell lung cancer or triple-negative breast cancer improves progression free survival (PFS), defined as time from randomization to disease progression or death, as compared to standard of care therapy alone.
1 secondary outcome
Overall Survival
Time frame: Up to 2 years
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 27 Feb 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.
Amy Xu, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic Body Radiotherapy/SBRT in people with Triple Negative Breast Cancer and Non Small Cell Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 12 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 18 inclusion and 6 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 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 Amy Xu, MD, PhD (646-888-6863, xua@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: Up to 2 years). 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 27 Feb 2026.