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TNBC - Triple-Negative Breast CancerPhase 2NCT03808662

Randomized Study of Stereotactic Body Radiation Therapy (SBRT) in Patients With Oligoprogressive Metastatic Cancers of the Breast and Lung

A Phase 2 study testing Sterotactic Body Radiotherapy/SBRT in people with TNBC - Triple-Negative Breast Cancer and Triple Negative Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 10 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is determine if receiving stereotactic body radiation(SBRT) when participants' metastatic tumors have just begun to grow increase the length of time before disease gets worse Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sterotactic Body Radiotherapy/SBRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
10 sitesin 2 countries
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

  • Age 18 or older
  • Willing and able to provide informed consent
  • Metastatic disease detected on imaging and histologically confirmed:
  • Triple negative breast cancer TNBC (ER <1%, PR <1%, her-2-neu 0- 1+ by IHC or FISH-negative or as determined by MD discretion)
  • OR NSCLC (without known EGFR mutation or ALK/ROS1 rearrangement)
  • OR Other high-risk breast cancer (per physician's discretion) progressed on hormone or systemic therapy, regardless of ER/HER2 status
Show all 48Show fewer
  • OR NSCLC with EGFR, ALK, or ROS1 targetable molecular alterations with disease progression on first-line tyrosine kinase inhibitor
  • Note:
  • Biopsy of metastasis prior to enrollment is per treating physician's discretion per standard of care. It is preferred but not required.
  • These patients are selected for the study given the similar survival outcomes when given standard of care therapies
  • Patient has received at least first-line prior treatment with systemic therapy (either cytotoxic or targeted, including maintenance therapies).
  • Patients who received prior immunotherapy are allowed.
  • Patients who had any prior radiation therapy near or overlapping with the oligoprogressive sites are allowed to enroll.
  • Patients with the following medical conditions precluding them from participating in other systemic therapy or drug trials are allowed:
  • active liver disease, including viral or other hepatitis, or cirrhosis
  • any other significant medical condition not under control, including any acute coronary syndrome within the past 6 months.
  • a permanent pacemaker
  • a QTc > 480 ms in the baseline EKG
  • peripheral neuropathy of grade >/= 2 per NCI CTCAE
  • history or known autoimmune disease
  • current chronic systemic steroid therapy or any immunosuppressive therapy
  • history of primary immunodeficiency or solid organ transplant
  • known positive human immunodeficiency virus (HIV), chronic or active hepatitis B or C, or active hepatitis A
  • active infection requiring systemic antibiotic therapy
  • Patients can have more than 5 metastases but can only have 1-5 oligo-progressive lesions.
  • Oligoprogression, defined as Response Evaluation Criteria in Solid Tumors (RECIST) or Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) documented progression in up to 5 individual lesions
  • Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria as a guide:
  • At least a 20% increase in the sum of the longest diameter (LD) of the lesion, taking as reference the smallest sum LD recorded since the last imaging OR
  • The appearance of one or more new lesions OR
  • New/malignant FDG uptake in the absence of other indications of progressive disease or an anatomically stable lesion OR
  • >/= 5mm increase in the diameter sum of the lesion
  • OR
  • Using Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) as a guide:
  • >30% increase in 18F-FDG SUV peak, with >0.8 SUV units increase in tumor SUV from the baseline scan in pattern typical of tumor and not of infection/treatment effect OR
  • Visible increase in the extent of 18F-FDG tumor uptake OR
  • New 18F-FDG avid lesions typical of cancer (including new bone lesion) and not related to treatment effect and/or infection
  • OR
  • Development of a new soft tissue metastatic lesion at least 5mm in size or any new bone metastasis
  • OR
  • Progressive enlargement of a known metastasis on 2 consecutive imaging studies at least 2 months apart with a minimum 5mm increase in size
  • All sites of oligoprogression can be safely treated
  • Maximum 5 progressing metastases in any single extra-cranial organ system (i.e. lung, liver, bone)
  • 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
  • No restriction on the total number of metastases
  • Note: 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 patients with brain metastases and oligoprogression elsewhere where stereotactic radiation to the brain is warranted, the brain lesions can be treated prior to randomization. This will not be counted toward the 5 progressive lesions.
  • Any symptomatic metastatic sites requiring prompt palliative radiation (e.g. cord compression) can also be treated with standard of care radiation prior to randomization. This will not be counted toward the 5 progressive lesions.
  • 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.

Who cannot join

  • Pregnancy.
  • Leptomeningeal disease.
  • Serious medical comorbidities precluding radiotherapy, such as ataxia-telangiectasia or scleroderma.
  • Any other condition which in the judgment of the investigator would make the patient inappropriate for entry into this study.

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

United States9 sites

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering Rockville Centre

    Rockville Centre, New York, 11570

  • Fred Hutchinson Cancer Research Center (Data Analysis Only)

    Seattle, Washington, 98109

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

Other trials in United States

Canada1 site

  • Princess Margaret Hospital/Ontario Cancer Institute (Data Analysis Only)

    Toronto, Ontario

Other trials in Canada

About this study

Official title: Precision Radiation for OligoMetastatIc and MetaStatic DiseasE (PROMISE)-004: Consolidative Use of Radiotherapy to Block (CURB) Oligoprogression

The purpose of this study is determine if receiving stereotactic body radiation(SBRT) when participants' metastatic tumors have just begun to grow increase the length of time before disease gets worse

Being tested
Sterotactic Body Radiotherapy/SBRT, Standard of care
Keywords
SBRT, Stereotactic Body Radiotherapy, Non-hematology metatstatic cancer, non-CNS oligo-progressive disease, intracranial metastatic disease, Memorial Sloan Kettering Cancer Center, 18-431
Medical subject headings
Triple Negative Breast Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • Sterotactic Body Radiotherapy/SBRTRadiation

    In general, it is recommended using 9-10 Gy x 3 or 10 Gy x 5 fractions given every other day. Physicians should try to give the highest BED whenever possible while respecting normal tissue tolerance. All lesions are recommended to receive a biologically effective dose (BED) of 60 Gy or higher (BED10≥70), assuming α/β ratio of 10 and using the linear-quadratic model: BED = nd x [1 + d/(α/β)] where n is number of fractions and d is dose per fraction. Sometimes BED ≥80 Gy is preferred, with lower doses ≥50 Gy allowed at the discretion of the treating physician for concerns about normal tissue toxicity.

  • Standard of careDrug

    Standard of care per physician discretion

Study groups in NCT03808662
Study groupRoleWhat they receive
Arm 1: Early Stereotactic Body Radiotherapy/SBRTExperimentalSBRT to all oligoprogressive sites
Receives: Radiation: Sterotactic Body Radiotherapy/SBRT
Arm 2:Standard of CareActive comparatorNot described
Receives: Drug: Standard of care

What is being measured

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

  1. Progression Free Survival

    To study if the addition of early SBRT to extra-cranial oligo-progressive metastatic disease could prolong PFS compared to no SBRT. PFS is defined as the time from randomization to disease progression or death.

    Measured: Up to 52 weeks after final participant is enrolled

Secondary outcomes (1)

  1. Overall survival

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Timeline

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

  1. First posted17 Jan 2019
  2. Study start16 Jan 2019
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03808662
Sponsor's protocol ID
18-431
Status last verified
Feb 2026
First submitted
16 Jan 2019
Last updated
4 Feb 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
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 following one year after publication and for up to 36 months later. 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.

Publications

  • Tsai CJ, Yang JT, Shaverdian N, Patel J, Shepherd AF, Eng J, Guttmann D, Yeh R, Gelblum DY, Namakydoust A, Preeshagul I, Modi S, Seidman A, Traina T, Drullinsky P, Flynn J, Zhang Z, Rimner A, Gillespie EF, Gomez DR, Lee NY, Berger M, Robson ME, Reis-Filho JS, Riaz N, Rudin CM, Powell SN; CURB Study Group. Standard-of-care systemic therapy with or without stereotactic body radiotherapy in patients with oligoprogressive breast cancer or non-small-cell lung cancer (Consolidative Use of Radiotherapy to Block [CURB] oligoprogression): an open-label, randomised, controlled, phase 2 study. Lancet. 2024 Jan 13;403(10422):171-182. doi: 10.1016/S0140-6736(23)01857-3. Epub 2023 Dec 14.

    PubMed 38104577

  • Lee J, Koom WS, Byun HK, Yang G, Kim MS, Park EJ, Ahn JB, Beom SH, Kim HS, Shin SJ, Kim K, Chang JS. Metastasis-Directed Radiotherapy for Oligoprogressive or Oligopersistent Metastatic Colorectal Cancer. Clin Colorectal Cancer. 2022 Jun;21(2):e78-e86. doi: 10.1016/j.clcc.2021.10.009. Epub 2021 Nov 18.

    PubMed 34903471

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sterotactic Body Radiotherapy/SBRT in people with TNBC - Triple-Negative Breast Cancer and Triple Negative Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 10 sites in 2 countries.

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 48 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 4 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 10 sites in United States, Canada. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: Up to 52 weeks after final participant is enrolled). 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 NCT03808662, which also lists 2 linked publications.

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 4 Feb 2026.

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