Breast CancerVALOROUSNCT06103669
Locally ablatiVe therApy in oLigO-pRogressive sOlid tUmorS (VALOROUS)
A study testing Ablative local therapy in people with Breast Cancer and Oligoprogressive, run by University of California, Davis at 1 site in United States.
Trial summary
This is a phase 2 pragmatic study that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Oligoprogressive, Head and Neck Cancer
- What is being tested?
- Ablative local therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2023to Dec 2033
- 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
- Must have one of the following histologically and/or biochemically confirmed genitourinary malignancies:
- Cohort A: Breast Malignancy
- Cohort B: Gynecological Malignancy
- Cohort C: Head and Neck Malignancies
- Cohort D: Sarcomas
- Cohort E: Other solid malignancy specified in the protocol
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- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Age ≥18 years at time of consent.
- Currently on systemic therapy and a candidate to continue their current line of systemic therapy with no more than a planned 30-day break to allow for local ablative therapy.
- ≥ 1 line of systemic therapy for metastatic disease with ≥ 3 months of clinical benefit on most recent line of systemic therapy prior to the development of new metastatic lesions. [Clinical benefit: Treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment]
- ≤ 5 progressing or new metastatic lesions.
- All progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and/ interventional radiologist.
Who cannot join
- Medical comorbidities precluding locally ablative therapies.
- History of treatment related toxicities that limit or prohibit application of locally ablative therapies.
- Progressing intracranial lesions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, Davis
Sacramento, California, 95817
Office of Clinical Research, 916-382-6970, OCRReferral@health.ucdavis.edu
Xiao Zhao, MD
About this study
This is a phase 2 pragmatic study that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. The primary outcome measure is the time to treatment failure (defined as time to change in systemic failure or permanent discontinuation of therapy) following locally ablative therapy.
Read the detailed description
This is a phase 2 pragmatic study at a single site that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. The primary endpoint is disease control at 3 months, defined as continuation in systemic cancer therapy without any changes or permanent discontinuation for 3 months following first day of ablative local therapy. Participants will receive ablative local therapy per standard practices in addition to their systemic therapy and will be followed for up to 5 years following ablative local therapy. Participants will be assigned stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy per the discretion of treating radiation oncologist and/or interventional radiologist.
- Conditions
- Breast Cancer, Oligoprogressive, Head and Neck Cancer, Sarcoma, Other Cancer
- Being tested
- Ablative local therapy
- Medical subject headings
- Breast Neoplasms, Head and Neck Neoplasms, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablative local therapyDevice
Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy
| Study group | Role | What they receive |
|---|---|---|
| Ablative local therapy | Experimental | Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy Receives: Device: Ablative local therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with controlled disease
Number of participants with controlled disease at 3 months, defined as continuation in systemic cancer therapy without any changes or permanent discontinuation for 3 months following first day of ablative local therapy
Measured: 3 months from the first day of ablative local therapy
Secondary outcomes (3)
Number of participants experiencing grade ≥ 3 adverse events attributable to ablative local therapy
Number of participants experiencing grade ≥ 3 adverse events (except for hematologic and electrolyte abnormalities) attributable to ablative local therapy occurring up to 2 years from the first day of ablative local therapy
Measured: Up to 2 years from the first day of ablative local therapy
Median overall survival
Median overall survival stratified by primary tumor type
Measured: Up to 1 year from the first day of ablative local therapy
Time to treatment failure
Time to treatment failure, defined as time to change in systemic therapy or permanent discontinuation of cancer therapy
Measured: Up to 1 year from the first day of ablative local therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start5 Oct 2023
- Primary completionDec 2033 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Xiao Zhao, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103669
- Sponsor's protocol ID
- UCDCC314
- Other IDs
- P30CA093373
- Acronym
- VALOROUS
- Status last verified
- Jul 2026
- First submitted
- 19 Oct 2023
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locally ablatiVe therApy in oLigO-pRogressive sOlid tUmorS (VALOROUS)
- ClinicalTrials.gov ID
- NCT06103669
- Acronym / sponsor ID
- VALOROUS / UCDCC314
- Conditions
- Breast Cancer, Oligoprogressive, Head and Neck Cancer, Sarcoma, Other Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- Dec 2033 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 27 Oct 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.
This is a phase 2 pragmatic study that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. The primary outcome measure is the time to treatment failure (defined as time to change in systemic failure or permanent discontinuation of therapy) following locally ablative therapy.
Detailed description
This is a phase 2 pragmatic study at a single site that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. The primary endpoint is disease control at 3 months, defined as continuation in systemic cancer therapy without any changes or permanent discontinuation for 3 months following first day of ablative local therapy. Participants will receive ablative local therapy per standard practices in addition to their systemic therapy and will be followed for up to 5 years following ablative local therapy. Participants will be assigned stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy per the discretion of treating radiation oncologist and/or interventional radiologist.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ablative local therapy | Experimental | Device: Ablative local therapyStereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Must have one of the following histologically and/or biochemically confirmed genitourinary malignancies:
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Age ≥18 years at time of consent.
- Currently on systemic therapy and a candidate to continue their current line of systemic therapy with no more than a planned 30-day break to allow for local ablative therapy.
Key exclusion criteria (3 listed)
- Medical comorbidities precluding locally ablative therapies.
- History of treatment related toxicities that limit or prohibit application of locally ablative therapies.
- Progressing intracranial lesions.
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 |
|---|---|---|
| Ablative local therapyStereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy | Device | Ablative local therapy |
Primary outcome
Number of participants with controlled disease
Time frame: 3 months from the first day of ablative local therapy
Number of participants with controlled disease at 3 months, defined as continuation in systemic cancer therapy without any changes or permanent discontinuation for 3 months following first day of ablative local therapy
3 secondary outcomes
Number of participants experiencing grade ≥ 3 adverse events attributable to ablative local therapy
Time frame: Up to 2 years from the first day of ablative local therapy
Median overall survival
Time frame: Up to 1 year from the first day of ablative local therapy
Time to treatment failure
Time frame: Up to 1 year from the first day of ablative local therapy
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 8 Jul 2026.
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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.
Xiao Zhao, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablative local therapy in people with Breast Cancer and Oligoprogressive, run by University of California, Davis at 1 site 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 13 inclusion and 3 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 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Office of Clinical Research (916-382-6970, OCRReferral@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with controlled disease (time frame: 3 months from the first day of ablative local therapy). 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 8 Jul 2026.