Anatomic Stage IV Breast Cancer AJCC v8Phase 2NCT06525766
Adaptive Therapy With Capecitabine for Treatment of Metastatic ER Positive, HER2 Negative Breast Cancer
A Phase 2 study testing Biospecimen Collection, Bone Scan and Capecitabine in people with Anatomic Stage IV Breast Cancer AJCC v8 and Estrogen-receptor-positive Breast Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
This phase II trial evaluates the effect of capecitabine on tumor response using imaging and tumor markers to adjust dose (adaptive therapy) in patients with estrogen receptor (ER) positive, HER2 negative breast cancer that has spread from where it first started to other areas in the body (metastatic). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anatomic Stage IV Breast Cancer AJCC v8, Estrogen-receptor-positive Breast Cancer, Metastatic HER2-Negative Breast Carcinoma
- What is being tested?
- Biospecimen Collection, Bone Scan and Capecitabine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 15 Oct 2030
- 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
- PRE-REGISTRATION: Provide written informed consent Note: Pre-registration should occur prior to screening research blood draws being completed
- PRE-REGISTRATION: Provider anticipates the patient will begin on capecitabine within 14 days or has started capecitabine within the past 42 days and has had a maximum of two cycles Note: Pre-registration should occur prior to screening research blood draws being completed
- REGISTRATION - INCLUSION CRITERIA
- Age ≥ 18 years
- Histological confirmation of estrogen-receptor positive (ER+), HER2-negative overexpression or amplification negative as per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines, metastatic breast cancer
- Measurable disease. Bone only disease allowed if associated with soft tissue component that is measurable by Response Evaluation Criteria is Solid Tumors (RECIST) 1.1 criteria
Show all 21Show fewer
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
- Hemoglobin ≥ 9.0 g/dL (obtained ≤ 14 days prior to registration), no transfusions allowed ≤ 14 days prior to registration
- Absolute neutrophil count (ANC) ≥ 1500/mm^3 (obtained ≤ 14 days prior to registration)
- Platelet count ≥ 100,000/mm^3 (obtained ≤ 14 days prior to registration)
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 14 days prior to registration)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 14 days prior to registration)
- Calculated creatinine clearance ≥ 30 ml/min using the Cockcroft-Gault formula (obtained ≤ 14 days prior to registration)
- Negative serum or urine pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only. NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Provide written informed consent
- Ability to complete questionnaire(s) by themselves or with assistance
- Willingness to provide mandatory blood specimens for correlative research
- Ability to undergo re-staging CT scans as required by the protocol
- Note: for patients who have had up to two cycles of capecitabine prior to joining the study, they must have had their initial CT imaging completed within 28 days of their first dose of capecitabine
- Willing to return to enrolling institution at the specified frequency for follow-up (during the active monitoring phase of the study)
- Cohort 2 only: Stable disease, partial or complete response on imaging after beginning capecitabine
Who cannot join
- Prior chemotherapy or use of antibody drug conjugate in the metastatic setting
- Note - Cohort 2 only: Patients can have had up to two cycles of capecitabine before joining the study
- Any of the following, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
- Pregnant persons
- Nursing persons
- Persons of childbearing potential who are unwilling to employ adequate contraception
Show all 25Show fewer
- Any of the following prior therapies:
- Major surgery ≤ 3 weeks prior to registration
- Radiation therapy ≤ 2 weeks prior to registration
- Evidence of visceral crisis or impending cord compression
- Evidence of uncontrolled brain metastasis requiring whole brain irradiation or intervention
- Uncontrolled intercurrent illness including, but not limited to:
- ongoing or active infection
- symptomatic congestive heart failure
- unstable angina pectoris
- uncontrolled cardiac arrhythmia
- chronic oxygen dependence
- respiratory failure
- or psychiatric illness/social situations that would limit compliance with study requirements
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- Other active malignancy ≤ 3 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix
- If there is a history of prior malignancy, they must not be receiving other cancer specific treatment. Except for antiestrogen treatment (aromatase inhibitors or selective estrogen modulators) for their cancer are permitted if they meet other eligibility criteria. Denosumab and zoledronic acid, are permitted as established adjunct therapies per guidelines
- History of myocardial infarction ≤ 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- Patients known to have certain homozygous or compound heterozygous dihydropyrimidine dehydrogenase (DPYD) variants that result in complete absence of deoxypyridinoline (DPD) activity. Test results do not need to be available prior to registration
- History of severe hypersensitivity reactions to fluorouracil or capecitabine
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
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Lida A. Mina, M.D.
About this study
Official title: Single Arm Pilot Trial of Adaptive Therapy (AT) With Capecitabine for the Treatment of Metastatic Estrogen Receptor Positive, Hormone Refractory Breast Cancer
This phase II trial evaluates the effect of capecitabine on tumor response using imaging and tumor markers to adjust dose (adaptive therapy) in patients with estrogen receptor (ER) positive, HER2 negative breast cancer that has spread from where it first started to other areas in the body (metastatic). Capecitabine is in a class of medications called antimetabolites. It is taken up by tumor cells and breaks down into fluorouracil, a substance that kills tumor cells. Adaptive therapy with capecitabine based on tumor burden response may slow or stop the growth of tumor cells in patients with metastatic ER positive, HER2 negative breast cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- Evaluate the feasibility of adaptive therapy (AT) in hormone receptor positive metastatic breast cancer, defined as the number of patients who can achieve AT modification for 2 or more cycles.
SECONDARY OBJECTIVES:
- To evaluate time to progression in patients receiving capecitabine AT defined as the interval between treatment start and tumor progression, or death in patients with no evidence of disease progression.
II. Assess overall survival in patients receiving capecitabine as adaptive therapy.
III. Evaluate patient related outcomes by measuring quality of life and global health status of patients on AT using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core 30 questionnaire EORTC QLQ C-30.
IV. Evaluate adverse events secondary to capecitabine using Common Terminology Criteria for Adverse Events (CTCAE) grading system version 5.0.
- Assess feasibility and accuracy of radiologic 3 dimensional (3D) volumetric approach in measuring target lesions.
EXPLORATORY OBJECTIVES:
- Assess circulating tumor deoxyribonucleic acid (DNA) (ctDNA) as a low-cost alternative to imaging for measuring tumor burden.
II. Identify gene signatures that could predict response and identify mechanisms of resistance to capecitabine using next generation sequencing technology, including:
IIa. Whole exome DNA sequencing from ctDNA at screening and end of treatment; IIb. Whole transcriptome ribonucleic acid (RNA) sequencing from ctDNA at and at screening and end of treatment.
III. ctDNA quantification is optional at day 1 (D-1).
OUTLINE:
INITIAL STANDARD PHASE: Patients who are capecitabine naive, receive standard dose of capecitabine orally (PO) twice daily (BID) on days 1-14 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients whose disease has responded or remains stable after 2 cycles continue to the Adaptive Phase.
ADAPTIVE PHASE: Patients who have had up to 2 cycles of capecitabine, receive 50% reduced dose of capecitabine PO BID on days 1-14 of each cycle. Patients undergo blood sample collection every cycle and computed tomography (CT) every other cycle for disease response assessment. Patients whose disease burden decreases < 10% on CT or blood begins receiving an additional 50% reduced dose of capecitabine PO BID on days 1-14 of each cycle. Patients whose disease burden is stable on CT or blood continue receiving initial Adaptive Phase dose of capecitabine PO BID on days 1-14 of each cycle. Patients whose disease burden increases > 10% on CT or blood begin receiving a 50% dose increase in capecitabine PO BID on days 1-14 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Additionally, patients undergo blood sample collection, CT or magnetic resonance imaging (MRI), and bone scan if indicated on study.
After completion of study treatment, patients are followed up every 3 months for up to 3 years from time of registration.
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Estrogen-receptor-positive Breast Cancer, Metastatic HER2-Negative Breast Carcinoma, Metastatic Breast Cancer
- Being tested
- Biospecimen Collection, Bone Scan, Capecitabine, Computed Tomography, Magnetic Resonance Imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Bone ScanProcedure or surgery
Also called Bone Scintigraphy
Undergo bone scan
CapecitabineDrug
Also called Ro 09-1978/000, Xeloda
Given PO
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (capecitabine) | Experimental | See Detailed Description. Receives: Procedure: Biospecimen Collection; Procedure: Bone Scan; Drug: Capecitabine; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to achieve adaptive therapy (AT)
Will be assessed by the proportion of patients (%) who are able to receive 2 or more cycles of AT with capecitabine divided by the total number of patients who have entered the AT phase of treatment (have stable or responsive disease).
Measured: Up to 5 years
Secondary outcomes (5)
Time to progression
Time to progression will be defined as the time from registration to the earliest date of documentation of disease progression.
Measured: At registration to disease progression up to 5 years
Overall survival (OS)
OS will be defined as the time from registration to death due to any cause.
Measured: At registration to death up to 5 years
Cumulative dose
The cumulative dose of capecitabine administered per patient will be assessed across patients receiving AT.
Measured: Up to 5 years
Incidence of adverse events (AEs)
The maximum grade for each type of AE will be recorded for each patient. Adverse events will be categorized according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: Up to 30 days after last dose of study drug
Quality of life - EORTC-QLQ-C30
Will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), a 30-question survey that measures the quality of life of cancer patients. The questionnaire has a score range of 0 to 100 points, with, higher scores indicating a better level of functioning.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Oct 2025
- Primary completion15 Oct 2030 (estimated)
- Study completion15 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage IV Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lida A. Mina, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525766
- Sponsor's protocol ID
- MC230303
- Other IDs
- NCI-2024-06184, 23-009851, MC230303
- Status last verified
- May 2026
- First submitted
- 24 Jul 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm Pilot Trial of Adaptive Therapy (AT) With Capecitabine for the Treatment of Metastatic Estrogen Receptor Positive, Hormone Refractory Breast Cancer
- ClinicalTrials.gov ID
- NCT06525766
- Acronym / sponsor ID
- MC230303
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Estrogen-receptor-positive Breast Cancer, Metastatic HER2-Negative Breast Carcinoma, Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 15 Oct 2030 (estimated)
- Study completion
- 15 Oct 2030 (estimated)
- First posted
- 29 Jul 2024 (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 phase II trial evaluates the effect of capecitabine on tumor response using imaging and tumor markers to adjust dose (adaptive therapy) in patients with estrogen receptor (ER) positive, HER2 negative breast cancer that has spread from where it first started to other areas in the body (metastatic). Capecitabine is in a class of medications called antimetabolites. It is taken up by tumor cells and breaks down into fluorouracil, a substance that kills tumor cells. Adaptive therapy with capecitabine based on tumor burden response may slow or stop the growth of tumor cells in patients with metastatic ER positive, HER2 negative breast cancer.
Detailed description
PRIMARY OBJECTIVE:
- Evaluate the feasibility of adaptive therapy (AT) in hormone receptor positive metastatic breast cancer, defined as the number of patients who can achieve AT modification for 2 or more cycles.
SECONDARY OBJECTIVES:
- To evaluate time to progression in patients receiving capecitabine AT defined as the interval between treatment start and tumor progression, or death in patients with no evidence of disease progression.
II. Assess overall survival in patients receiving capecitabine as adaptive therapy.
III. Evaluate patient related outcomes by measuring quality of life and global health status of patients on AT using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core 30 questionnaire EORTC QLQ C-30.
IV. Evaluate adverse events secondary to capecitabine using Common Terminology Criteria for Adverse Events (CTCAE) grading system version 5.0.
- Assess feasibility and accuracy of radiologic 3 dimensional (3D) volumetric approach in measuring target lesions.
EXPLORATORY OBJECTIVES:
- Assess circulating tumor deoxyribonucleic acid (DNA) (ctDNA) as a low-cost alternative to imaging for measuring tumor burden.
II. Identify gene signatures that could predict response and identify mechanisms of resistance to capecitabine using next generation sequencing technology, including:
IIa. Whole exome DNA sequencing from ctDNA at screening and end of treatment; IIb. Whole transcriptome ribonucleic acid (RNA) sequencing from ctDNA at and at screening and end of treatment.
III. ctDNA quantification is optional at day 1 (D-1).
OUTLINE:
INITIAL STANDARD PHASE: Patients who are capecitabine naive, receive standard dose of capecitabine orally (PO) twice daily (BID) on days 1-14 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients whose disease has responded or remains stable after 2 cycles continue to the Adaptive Phase.
ADAPTIVE PHASE: Patients who have had up to 2 cycles of capecitabine, receive 50% reduced dose of capecitabine PO BID on days 1-14 of each cycle. Patients undergo blood sample collection every cycle and computed tomography (CT) every other cycle for disease response assessment. Patients whose disease burden decreases < 10% on CT or blood begins receiving an additional 50% reduced dose of capecitabine PO BID on days 1-14 of each cycle. Patients whose disease burden is stable on CT or blood continue receiving initial Adaptive Phase dose of capecitabine PO BID on days 1-14 of each cycle. Patients whose disease burden increases > 10% on CT or blood begin receiving a 50% dose increase in capecitabine PO BID on days 1-14 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Additionally, patients undergo blood sample collection, CT or magnetic resonance imaging (MRI), and bone scan if indicated on study.
After completion of study treatment, patients are followed up every 3 months for up to 3 years from time of registration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (capecitabine) | Experimental | Procedure: Biospecimen Collection, Procedure: Bone Scan, Drug: Capecitabine, Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Other: Questionnaire AdministrationSee Detailed Description. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- PRE-REGISTRATION: Provide written informed consent Note: Pre-registration should occur prior to screening research blood draws being completed
- PRE-REGISTRATION: Provider anticipates the patient will begin on capecitabine within 14 days or has started capecitabine within the past 42 days and has had a maximum of two cycles Note: Pre-registration should occur prior to screening research blood draws being completed
- REGISTRATION - INCLUSION CRITERIA
- Age ≥ 18 years
- Histological confirmation of estrogen-receptor positive (ER+), HER2-negative overexpression or amplification negative as per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines, metastatic breast cancer
Key exclusion criteria (25 listed)
- Prior chemotherapy or use of antibody drug conjugate in the metastatic setting
- Any of the following, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
- Any of the following prior therapies:
- Evidence of visceral crisis or impending cord compression
- Evidence of uncontrolled brain metastasis requiring whole brain irradiation or intervention
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 |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Treatment (capecitabine) |
| Bone ScanAlso: Bone ScintigraphyUndergo bone scan | Procedure or surgery | Treatment (capecitabine) |
| CapecitabineAlso: Ro 09-1978/000, XelodaGiven PO | Drug | Treatment (capecitabine) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Treatment (capecitabine) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | Treatment (capecitabine) |
| Questionnaire AdministrationAncillary studies | Other | Treatment (capecitabine) |
Primary outcome
Ability to achieve adaptive therapy (AT)
Time frame: Up to 5 years
Will be assessed by the proportion of patients (%) who are able to receive 2 or more cycles of AT with capecitabine divided by the total number of patients who have entered the AT phase of treatment (have stable or responsive disease).
5 secondary outcomes
Time to progression
Time frame: At registration to disease progression up to 5 years
Overall survival (OS)
Time frame: At registration to death up to 5 years
Cumulative dose
Time frame: Up to 5 years
Incidence of adverse events (AEs)
Time frame: Up to 30 days after last dose of study drug
Quality of life - EORTC-QLQ-C30
Time frame: Up to 5 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 12 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Anatomic Stage IV Breast Cancer AJCC v8
RecruitingPhase 2
Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer
Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Active, not recruiting
Positron Emission Tomography in Women With Advanced HER2-Positive Breast Cancer
Breast Cancer, Stage IV Breast Cancer
Active, not recruitingPhase 2
Nab-Paclitaxel in Treating Older Patients With Locally Advanced or Metastatic Breast Cancer
Locally Advanced Breast Carcinoma, Metastatic Breast Carcinoma
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.
Lida A. Mina, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biospecimen Collection, Bone Scan and Capecitabine in people with Anatomic Stage IV Breast Cancer AJCC v8 and Estrogen-receptor-positive Breast Cancer, run by Mayo Clinic 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 21 inclusion and 25 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 12 Aug 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.
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 Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to achieve adaptive therapy (AT) (time frame: Up to 5 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 12 Aug 2026.