Breast CancerPhase 2DARENCT04567420
DNA-guided Second Line Adjuvant Therapy for High Residual Risk, Estrogen Receptor Positive, HER-2 Negative Breast Cancer (DARE)
A Phase 2 study testing Palbociclib, Fulvestrant and Adjuvant Therapy in people with Breast Cancer, run by Criterium, Inc. at 19 sites in United States.
Trial summary
A randomized, Phase II trial of circulating tumor DNA-guided second line Adjuvant therapy for high Residual risk, Estrogen Receptor positive, HER-2 negative breast cancer (DARE) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Palbociclib, Fulvestrant and Adjuvant Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 19 sitesUnited States
- Study dates
- 9 Feb 2021to 31 Dec 2028
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- High risk for recurrence HER-2 negative, ER positive invasive breast cancer. For this study, ER positivity is defined as equal to or greater than 10% ER positivity by immunohistochemistry, regardless of progesterone receptor (PR) status. Patients who are PR positive but ER negative are not eligible.
- Patients may have completed adjuvant endocrine therapy and are within 7 years since the date of their definitive breast surgery, or may be currently taking an aromatase inhibitor, or tamoxifen, as adjuvant endocrine therapy and have completed at least 6 months (i.e. 24 weeks), but no more than 7 years of endocrine therapy. Prior CDK4/6 therapy in the adjuvant setting, including participation in the PALLAS and PENELOPE trials, is allowed if the last treatment was 12 or more months ago. Adjuvant bisphosphonate therapy is allowed
- High risk for recurrence is defined as any one of the following (these criteria apply equally to both patients who underwent surgery first and those who received neoadjuvant chemotherapy or endocrine therapy before surgery). (i) Four or more involved ipsilateral axillary lymph nodes or positive ipsilateral supraclavicular, or ipsilateral infraclavicular, or internal mammary lymph nodes at diagnosis or after preoperative systemic therapy, regardless of tumour size. Microscopic positive lymph node (i.e. <2 mm tumor deposit) is not counted as positive for eligibility for patients who underwent surgery first without any preoperative systemic therapy. Microscopic positive lymph nodes (i.e. <2 mm tumor deposit) are considered as positive nodes for eligibility for patients who received preoperative systemic therapy. (ii) Tumor size >5 cm and at least one macroscopically positive lymph node (i.e. >2 mm tumor deposit).
- Diagnosis of Inflammatory Breast Cancer.
- Formalin fixed paraffin embedded tissue from the primary breast cancer available to be sent to Natera to perform ctDNA testing.
- Signed and dated informed consent, including willingness to be randomized to standard of care versus fulvestrant + palbociclib.
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- ctDNA positivity by the Signatera assay, defined as 2 of the 16 cancer specific markers positive in plasma.
- Patients with positive Signatera results obtained in the context of commercial testing, outside of the screening phase of this trial, are also eligible for randomization if they meet other eligibility criteria.
- No evidence of metastatic disease on CT scan of the chest, abdomen and pelvis.
- If imaging, after review with a radiologist, is low probability for metastatic disease, patients may proceed to randomization.
- Patients with suspicious but inconclusive imaging results should undergo a diagnostic biopsy, if biopsy is negative patients are eligible for randomization.
- Patients with positive imaging that is conclusive of metastatic disease, or with biopsy proven metastatic disease, are not eligible for randomization.
- Pre-menopausal women and male patients must be willing to use an adequate method of contraception for the duration of trial treatment and for 4 additional weeks after completion of treatment in the control arm, and for 2 years after the last dose of fulvestrant, if randomized into the experimental arm Post- menopausal status is defined as:
- Documented bilateral oophorectomy, or
- Age ≥ 60 years, or
- Age < 60 years and amenorrhoeic for ≥ 12 consecutive months and FSH and estradiol levels in the post-menopausal range according to the institutional reference range for post- menopausal.
- Adequate contraception is defined as:
- ONE highly effective form (i.e. abstinence, surgical sterilization through bilateral tubal ligation, vasectomy), or
- TWO effective forms (e.g. non-hormonal IUD and condom / occlusive cap with spermicidal foam / gel / film / cream / suppository).
- Abstinence is to be interpreted as "true abstinence" for heterosexual intercourse and therefore, "periodic abstinence" (e.g. calendar, symptothermal, post-ovulation methods) and withdrawal (coitus interruptus) are not considered highly effective.
Who cannot join
- Prior or current treatment with fulvestrant, or current treatment with a CDK4/6 inhibitor, or treatment in the prior 12 months.
- Patients cannot start participation in another therapeutic clinical trial for breast cancer during participation in this trial unless disease progression occurred, or patient withdrew consent for participation in the current trial.
- Patients with current or past invasive cancer, other than breast cancer are not eligible, except: Adequately treated basal or squamous cell carcinoma of the skin and cancer survivors of previously diagnosed invasive cancer, who were treated with a curative intent, have no evidence of disease recurrence for 5 years or more, and are considered low risk for future recurrence by the treating physician are also eligible.
- Patients with a second HER2 positive or triple negative synchronous breast cancer.
- Patients with known contraindications to receive fulvestrant and palbociclib or those who are unable to tolerate these drugs are not eligible (e.g. absolute neutrophil count less than <1000/mm3)
- Any concurrent severe and uncontrolled medical condition that would, in the Investigator' opinion cause unacceptable safety risks or compromise compliance with the protocol including but not limited to:
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- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral medication (e.g. Crohn's disease, ulcerative diseases, uncontrolled chronic nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
- History of pneumonitis, interstitial lung disease or pulmonary fibrosis
- Known history of Human Immunodeficiency Virus (HIV) (testing is not mandatory)
- Known active Hepatitis B or Hepatitis C (testing is not mandatory)
- Females who are pregnant or breastfeeding
- History of bleeding diathesis (i.e. disseminated intravascular coagulation, clotting factor deficiency) that preclude the IM injections of fulvestrant or LHRH agonist as applicable.
- Patients taking any CYPC3A4 strong inducers and inhibitors, that cannot be changed.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, 87131
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
University of Colorado Cancer Center
Aurora, Colorado, 80045
The Ohio State University Wexner Medical Center James Cancer Hospital
Columbus, Ohio, 43210
Intermountain
Golden, Colorado, 80401
PRiSMs Group
Laredo, Texas, 78041
Cancer Partners of Nebraska
Lincoln, Nebraska, 68516
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of Wisconsin Clinical Science Center
Madison, Wisconsin, 53792
Yale Cancer Center
New Haven, Connecticut, 06510
Louisiana State University Health Sciences Center- New Orleans
New Orleans, Louisiana, 70112
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Oregon Health and Science University
Portland, Oregon, 97239
Virginia Cancer Institute
Richmond, Virginia, 23229
Swedish Cancer Institute
Seattle, Washington, 98104
Stony Brook University Cancer Center
Stony Brook, New York, 11794
University of Arizona Cancer Center
Tucson, Arizona, 85724
About this study
Official title: A Randomized, Phase II Trial of Circulating Tumor DNA-guided Second Line Adjuvant Therapy for High Residual Risk, Estrogen Receptor Positive, HER-2 Negative Breast Cancer (DARE)
A randomized, Phase II trial of circulating tumor DNA-guided second line Adjuvant therapy for high Residual risk, Estrogen Receptor positive, HER-2 negative breast cancer (DARE)
Read the detailed description
Surveillance population and ctDNA screening (up to 1000 patients): High risk ER positive, HER2-, breast cancer patients who have completed adjuvant endocrine therapy, or are currently receiving adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen and are within 7 years since completion of definitive breast surgery are eligible for ctDNA screening.
In order to start ctDNA surveillance, patients must have completed at least 6 months, but no more than 7 years of adjuvant endocrine therapy of treatment without distant recurrence. Prior adjuvant CDK4/6 therapy is allowed, but at least 12 months must have elapsed since completing CDK4/6 therapy and enrolling into ctDNA surveillance on this study. Participants in the PENELOPE and PALLAS clinical trials who received Palbociclib are also eligible if meet all required eligibility criteria.
For screening, patients will undergo Signatera testing during routine follow up clinic visits. The current ASCO/NCCN breast cancer practice guidelines recommend follow up visits every 4 to 6 months at the treating physician's discretion. We anticipate that screening positivity rates will be the highest in patients between years 1-5 after initial diagnosis, based on the annual hazard rates of recurrence in ER positive breast cancer.
However, since up to 50% of all recurrences occur after 5 years of follow-up, we allow starting ctDNA screening up to 7 years after starting adjuvant endocrine therapy if a patient meets criteria for high risk.
Randomized phase II (N=100): Patients who become ctDNA positive during ctDNA surveillance will have systemic staging with CT of the chest, abdomen and pelvis, and those without radiographic evidence of metastatic disease will be randomized 1:1 to receive palbociclib plus fulvestrant for two years or continue standard of care endocrine therapy. Pre- and peri- menopausal patients randomized to the fulvestrant palbociclib arm will require GnRH analogue therapy. Patients in both treatment arms may continue adjuvant bisphosphonate therapy and patients in the control arm may switch between different brands of aromatase inhibitors for better tolerance or patient preference. No other, non-protocol directed anticancer therapy is allowed. The maximum duration of treatment is 2 years. A patient may complete a maximum of 26 cycles of treatment (for patients without interruptions or delays). The goal is not to administer a specific number of cycles, but to allow for the completion of any cycles initiated prior to 2 years from randomization. Patients who have completed 2 years of fulvestrant and palbociclib without recurrence may resume their originally planned standard of care adjuvant therapy to complete a total of 5 or 10 years of endocrine therapy at the discretion of the treating physician.
- Conditions
- Breast Cancer
- Being tested
- Palbociclib, Fulvestrant, Adjuvant Therapy
- Keywords
- ctDNA, breast cancer, high residual risk
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalbociclibDrug
Also called IBRANCE
4 week cycles
FulvestrantDrug
Also called Faslodex
4 week cycles
Adjuvant TherapyDrug
Also called Standard of Care
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Palbociclib/Fulvestrant Combination Receives: Drug: Palbociclib; Drug: Fulvestrant |
| Arm B | Active comparator | Adjuvant Therapy Receives: Drug: Adjuvant Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surveillance/ctDNA screening Phase
Primary objective of the ctDNA screening (surveillance) phase is to assess the incidence of ctDNA detection (i.e. ctDNA positivity) in patients with ER positive HER2- breast cancer who are receiving standard of care adjuvant endocrine therapy but remain high risk for recurrence.
Measured: enrollment
Therapeutic Phase
Primary objective of the therapeutic randomized phase is to assess whether palbociclib plus fulvestrant improves relapse free survival compared to standard endocrine therapy in patients with ER positive HER2 negative breast cancer with detectable circulating tumor DNA during adjuvant endocrine therapy without clinical evidence of metastatic disease.
Measured: through study completion, an average of 6 years
Secondary outcomes (5)
Secondary Objective 1: Feasibility- correlation between clinically apparent metastatic or local disease and positive ctDNA result.
Estimate proportion of patients who have clinically apparent metastatic or local disease (i.e. imaging positive) at the time of first positive ctDNA result.
Measured: enrollment
Secondary Objective 2: Efficacy- assess the ability of positive ctDNA results to predict clinical relapse.
Assess the positive predictive value and specificity of positive ctDNA result to predict subsequent clinical relapse, and estimate the time to relapse in the control arm of the randomized trial.
Measured: through study completion, an average of 6 years
Secondary Objective 3: Efficacy- assess whether ctDNA clearance is associated with improved relapse free survival and overall survival.
To assess whether ctDNA clearance is associated with improved relapse free survival and overall survival compared to non-clearance in the palbociclib plus fulvestrant arm.
Measured: through study completion, an average of 6 years
Secondary Objective 4: Efficacy- assess the efficacy of the combination arm, palbociclib plus fulvestrant compared to the control arm.
To assess whether palbociclib plus fulvestrant compared to the control arm improves (i) ctDNA clearance at 3, 6 and 24 months, (ii) distant metastasis free survival, (iii) invasive disease-free survival, (iv) overall survival, (v) the number of patients who are recurrence free at 24 months.
Measured: through study completion, an average of 6 years
Secondary Objective 5: Safety and Tolerability- number of participants with treatment-related adverse event as assed by CTCAE V5.0.
To assess the tolerability and safety of treatments.
Measured: through study completion, an average of 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start9 Feb 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Criterium, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lajos Pusztai, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567420
- Sponsor's protocol ID
- DARE
- Acronym
- DARE
- Status last verified
- Oct 2026
- First submitted
- 3 Sep 2020
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase II Trial of Circulating Tumor DNA-guided Second Line Adjuvant Therapy for High Residual Risk, Estrogen Receptor Positive, HER-2 Negative Breast Cancer (DARE)
- ClinicalTrials.gov ID
- NCT04567420
- Acronym / sponsor ID
- DARE / DARE
- Conditions
- Breast Cancer
- Keywords
- ctDNA, breast cancer, high residual risk
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Criterium, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Sep 2020 (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.
A randomized, Phase II trial of circulating tumor DNA-guided second line Adjuvant therapy for high Residual risk, Estrogen Receptor positive, HER-2 negative breast cancer (DARE)
Detailed description
Surveillance population and ctDNA screening (up to 1000 patients): High risk ER positive, HER2-, breast cancer patients who have completed adjuvant endocrine therapy, or are currently receiving adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen and are within 7 years since completion of definitive breast surgery are eligible for ctDNA screening.
In order to start ctDNA surveillance, patients must have completed at least 6 months, but no more than 7 years of adjuvant endocrine therapy of treatment without distant recurrence. Prior adjuvant CDK4/6 therapy is allowed, but at least 12 months must have elapsed since completing CDK4/6 therapy and enrolling into ctDNA surveillance on this study. Participants in the PENELOPE and PALLAS clinical trials who received Palbociclib are also eligible if meet all required eligibility criteria.
For screening, patients will undergo Signatera testing during routine follow up clinic visits. The current ASCO/NCCN breast cancer practice guidelines recommend follow up visits every 4 to 6 months at the treating physician's discretion. We anticipate that screening positivity rates will be the highest in patients between years 1-5 after initial diagnosis, based on the annual hazard rates of recurrence in ER positive breast cancer.
However, since up to 50% of all recurrences occur after 5 years of follow-up, we allow starting ctDNA screening up to 7 years after starting adjuvant endocrine therapy if a patient meets criteria for high risk.
Randomized phase II (N=100): Patients who become ctDNA positive during ctDNA surveillance will have systemic staging with CT of the chest, abdomen and pelvis, and those without radiographic evidence of metastatic disease will be randomized 1:1 to receive palbociclib plus fulvestrant for two years or continue standard of care endocrine therapy. Pre- and peri- menopausal patients randomized to the fulvestrant palbociclib arm will require GnRH analogue therapy. Patients in both treatment arms may continue adjuvant bisphosphonate therapy and patients in the control arm may switch between different brands of aromatase inhibitors for better tolerance or patient preference. No other, non-protocol directed anticancer therapy is allowed. The maximum duration of treatment is 2 years. A patient may complete a maximum of 26 cycles of treatment (for patients without interruptions or delays). The goal is not to administer a specific number of cycles, but to allow for the completion of any cycles initiated prior to 2 years from randomization. Patients who have completed 2 years of fulvestrant and palbociclib without recurrence may resume their originally planned standard of care adjuvant therapy to complete a total of 5 or 10 years of endocrine therapy at the discretion of the treating physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Palbociclib, Drug: FulvestrantPalbociclib/Fulvestrant Combination |
| Arm B | Active comparator | Drug: Adjuvant TherapyAdjuvant Therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- High risk for recurrence HER-2 negative, ER positive invasive breast cancer. For this study, ER positivity is defined as equal to or greater than 10% ER positivity by immunohistochemistry, regardless of progesterone receptor (PR) status. Patients who are PR positive but ER negative are not eligible.
- Patients may have completed adjuvant endocrine therapy and are within 7 years since the date of their definitive breast surgery, or may be currently taking an aromatase inhibitor, or tamoxifen, as adjuvant endocrine therapy and have completed at least 6 months (i.e. 24 weeks), but no more than 7 years of endocrine therapy. Prior CDK4/6 therapy in the adjuvant setting, including participation in the PALLAS and PENELOPE trials, is allowed if the last treatment was 12 or more months ago. Adjuvant bisphosphonate therapy is allowed
- High risk for recurrence is defined as any one of the following (these criteria apply equally to both patients who underwent surgery first and those who received neoadjuvant chemotherapy or endocrine therapy before surgery). (i) Four or more involved ipsilateral axillary lymph nodes or positive ipsilateral supraclavicular, or ipsilateral infraclavicular, or internal mammary lymph nodes at diagnosis or after preoperative systemic therapy, regardless of tumour size. Microscopic positive lymph node (i.e. <2 mm tumor deposit) is not counted as positive for eligibility for patients who underwent surgery first without any preoperative systemic therapy. Microscopic positive lymph nodes (i.e. <2 mm tumor deposit) are considered as positive nodes for eligibility for patients who received preoperative systemic therapy. (ii) Tumor size >5 cm and at least one macroscopically positive lymph node (i.e. >2 mm tumor deposit).
- Formalin fixed paraffin embedded tissue from the primary breast cancer available to be sent to Natera to perform ctDNA testing.
- Signed and dated informed consent, including willingness to be randomized to standard of care versus fulvestrant + palbociclib.
Key exclusion criteria (13 listed)
- Prior or current treatment with fulvestrant, or current treatment with a CDK4/6 inhibitor, or treatment in the prior 12 months.
- Patients cannot start participation in another therapeutic clinical trial for breast cancer during participation in this trial unless disease progression occurred, or patient withdrew consent for participation in the current trial.
- Patients with current or past invasive cancer, other than breast cancer are not eligible, except: Adequately treated basal or squamous cell carcinoma of the skin and cancer survivors of previously diagnosed invasive cancer, who were treated with a curative intent, have no evidence of disease recurrence for 5 years or more, and are considered low risk for future recurrence by the treating physician are also eligible.
- Patients with a second HER2 positive or triple negative synchronous breast cancer.
- Patients with known contraindications to receive fulvestrant and palbociclib or those who are unable to tolerate these drugs are not eligible (e.g. absolute neutrophil count less than <1000/mm3)
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 |
|---|---|---|
| PalbociclibAlso: IBRANCE4 week cycles | Drug | Arm A |
| FulvestrantAlso: Faslodex4 week cycles | Drug | Arm A |
| Adjuvant TherapyAlso: Standard of CareStandard of Care | Drug | Arm B |
Primary outcome
Surveillance/ctDNA screening Phase
Time frame: enrollment
Primary objective of the ctDNA screening (surveillance) phase is to assess the incidence of ctDNA detection (i.e. ctDNA positivity) in patients with ER positive HER2- breast cancer who are receiving standard of care adjuvant endocrine therapy but remain high risk for recurrence.
Therapeutic Phase
Time frame: through study completion, an average of 6 years
Primary objective of the therapeutic randomized phase is to assess whether palbociclib plus fulvestrant improves relapse free survival compared to standard endocrine therapy in patients with ER positive HER2 negative breast cancer with detectable circulating tumor DNA during adjuvant endocrine therapy without clinical evidence of metastatic disease.
5 secondary outcomes
Secondary Objective 1: Feasibility- correlation between clinically apparent metastatic or local disease and positive ctDNA result.
Time frame: enrollment
Secondary Objective 2: Efficacy- assess the ability of positive ctDNA results to predict clinical relapse.
Time frame: through study completion, an average of 6 years
Secondary Objective 3: Efficacy- assess whether ctDNA clearance is associated with improved relapse free survival and overall survival.
Time frame: through study completion, an average of 6 years
Secondary Objective 4: Efficacy- assess the efficacy of the combination arm, palbociclib plus fulvestrant compared to the control arm.
Time frame: through study completion, an average of 6 years
Secondary Objective 5: Safety and Tolerability- number of participants with treatment-related adverse event as assed by CTCAE V5.0.
Time frame: through study completion, an average of 6 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 15 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Lajos Pusztai, MD principal investigator
Yale University
19 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 Palbociclib, Fulvestrant and Adjuvant Therapy in people with Breast Cancer, run by Criterium, Inc. at 19 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 20 inclusion and 13 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 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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?
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?
Surveillance/ctDNA screening Phase (time frame: enrollment). The study lists 2 primary outcomes in all. 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 15 Oct 2026.