Breast CancerPhase 2NAOMINCT04568616
Phase II Study of Neoadjuvant ArOMatase Inhibitor Therapy for ER+ Breast Cancer (NAOMI)
A Phase 2 study testing Letrozole 2.5mg in people with Breast Cancer and ER Positive Breast Cancer, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
Trial summary
This is a single-arm, open-label study testing the effects of neoadjuvant therapy with the aromatase inhibitor letrozole in post-menopausal women with Stage I-III ER+, HER2- breast cancer. Eligible subjects will be treated with letrozole therapy for 4 to 24 weeks prior to surgical resection of the tumor. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, ER Positive Breast Cancer
- What is being tested?
- Letrozole 2.5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Aug 2021to 13 Aug 2029
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic documentation of invasive breast cancer by core needle or incisional biopsy. Subjects without excess baseline tumor tissue are eligible and evaluable for Primary Objective #2 (re: adherence). Excess baseline biopsy tumor tissue sufficient to make ten 5- micron sections must be available for research use for a subject to be evaluable for Primary Objective #1 (re: molecular analyses).
- The invasive cancer must be estrogen receptor alpha (ER)-positive, with ER staining present in greater than 50% of invasive cancer cells by IHC.
- The invasive cancer must be HER2-negative (IHC 0-1+, or with a FISH ratio of <1.8 if IHC is 2+ or if IHC has not been done).
- Clinical Stage I-III invasive breast cancer with the intent to treat with surgical resection of the primary tumor. Baseline tumor must be ≥0.5 cm. For the optional research biopsy (from 5 subjects), tumor must be
- ≥1 cm.
- Patients with multicentric or bilateral disease are eligible if the subject is a candidate for clinically indicated neoadjuvant endocrine therapy. Samples from all available tumors are requested for research purposes.
Show all 12Show fewer
- Women over 18 years of age, for whom (A) neoadjuvant treatment with an aromatase inhibitor would be clinically indicated, and (B) adjuvant treatment with one of the following would be clinically indicated: tamoxifen; anastrozole; letrozole. Women must be postmenopausal, defined as last menstrual period >2 years prior to registration, or >1 yearer prior to registration with FSH and estradiol in post-menopausal range.
- Patients must meet the following clinical laboratory criteria:
- Absolute neutrophil count (ANC) ≥ 1,000/mm3 and platelet count ≥ 75,000/mm3.
- Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN.
- Ability to give informed consent.
Who cannot join
- Prior endocrine therapy for any histologically-confirmed cancer or prevention of breast cancer in the last 10 years is not allowed.
- Any other neoadjuvant therapy for breast cancer. Bisphosphonate or denosumab treatment for metabolic bone issues are allowed.
- Women who are pregnant or lactating.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
This is a single-arm, open-label study testing the effects of neoadjuvant therapy with the aromatase inhibitor letrozole in post-menopausal women with Stage I-III ER+, HER2- breast cancer. Eligible subjects will be treated with letrozole therapy for 4 to 24 weeks prior to surgical resection of the tumor. Tumor specimens obtained at baseline (diagnostic biopsy) and at surgery (surgical specimen) will be compared using molecular analyses. A subset of subjects will be asked to provide an optional research tumor biopsy prior to treatment for molecular analysis. Subjects will be evaluated for treatment adherence and provide feedback via survey questionnaires to identify potential causes of non-adherence.
Read the detailed description
Approximately 70% of breast cancers express estrogen receptor alpha (ER), which is activated by estrogens and typically drives cancer cell growth. Adjuvant therapy with anti-estrogens such as tamoxifen and aromatase inhibitors (AIs) is commonly used to inhibit ER to prevent cancer (re)growth after early-stage breast tumors are surgically removed. However, ~33% of such patients (~300,000 new cases per year worldwide) will eventually develop anti-estrogen-resistant breast cancer that is metastatic or locally advanced; at this stage, the disease is almost never cured using available therapies and is uniformly fatal. Therefore, more effective treatment early in the course of disease (i.e., in the adjuvant setting, shortly after surgical removal of a tumor) has huge potential to prevent cancer regrowth. Most often, ER+ breast cancers re-emerge in the years after the end of the standard five-year anti-estrogen treatment regimen (called 'late recurrence'). Recent data indicate that continued anti-estrogen therapy in patients who remain "disease-free" after five years of anti-estrogen therapy modestly prevents cancer recurrence. However, tumor cells are detectable in bone marrow of patients who are "disease-free." Thus, antiestrogen therapy in "disease-free" patients likely suppresses the growth of undetectable tumor cells, keeping them in a "clinically dormant" state (i.e., undetectable by standard clinical methods). Little is known about how such dormant cancer cells survive. This clinical study will help identify the signaling pathways essential for the survival of clinically dormant ER+ breast cancer cells to enable the development of more effective therapies to eradicate such cells and prevent cancer recurrence.
- Conditions
- Breast Cancer, ER Positive Breast Cancer
- Being tested
- Letrozole 2.5mg
- Keywords
- Letrozole, Aromatase Inhibitor
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letrozole 2.5mgDrug
Also called Femara
Aromatase Inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Letrozole 2.5mg tablet administered once daily for 4 to ~12 weeks (window of + 4 weeks for surgical scheduling flexibility) final dose taken the day of surgery. Receives: Drug: Letrozole 2.5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tumor CPT1-alpha levels
Determine whether residual cancer cells exhibit upregulation of the fatty acid transport CPT1-alpha (compared to baseline) following neoadjuvant endocrine therapy in patients with ER+ breast cancer.
Measured: Baseline to 4-12 Weeks
Determine subject adherence to endocrine therapy as measured via urine analysis
Urine analysis for drug metabolites will be used to determine subject adherence to endocrine therapy at three time points. (Protocol section 6.16.e) The outcome measure is percent of participants with adherence vs non-adherence as measured by urine samples tested for metabolites of adjuvant endocrine agents: tamoxifen, letrozole, anastrozole or exemestane. Urine tests will be recorded as positive or negative. Positive urine test = adherence.
Measured: Before surgery (within 14 days before surgery, or on day of surgery); approximately 1 year after surgery; and approximately 3 years after surgery
Treatment Satisfaction Questionnaire for Medication (TSQM) side effects score
The Treatment Satisfaction Questionnaire for Medication (TSQM) v1.4 assesses subjects' satisfaction with their breast cancer medication over the past 2-3 weeks, or since last use. A modified 12-item questionnaire will address 4 domains: effectiveness (Item 1), side effects (Items 2-6), convenience (Items 7-9), and global satisfaction (Items 10-12). Item 2 (experience of side effects; yes/no) will be evaluated independently. Subjects will be dichotomized at the median score for analysis.
Measured: Before surgery (approximately 4-24 weeks after the start of letrozole treatment), 1 year after surgery, and 3 years after surgery
Secondary outcomes (8)
Longest dimension(s) of primary tumor(s) pre- and post-treatment
The longest dimension(s) of the primary tumor(s) will be measured from radiological images acquired as per standard of care before neoadjuvant letrozole treatment, and after neoadjuvant letrozole treatment (prior to surgery). If multiple primary tumors are detected, the sum of the longest diameters will be used to provide a single measurement at each time point for each subject. Pre- and post-treatment tumor lengths will be compared.
Measured: Baseline and after approximately 4 to 24 weeks of treatment
Altered mitochondrial and fatty acid metabolism in surgical tissue specimen as compared to baseline tissue specimen.
Sections of baseline and post-neoadjuvant therapy tumor tissue specimens will be immunofluorescently stained using antibodies against TOM-20, ACC, FASN, CD36, and perilipin. Mitochondrial number and length (per cancer cell) will be measured using Halo software to determine whether neoadjuvant therapy cancer cells exhibit increased mitochondrial content compared to baseline cancer cells. Other markers will be scored by Histoscoring. Correlations between A) the duration of neoadjuvant letrozole, and B) expression of metabolic markers (CPT1-alpha, TOM-20, FASN, CD36, perilin) will be determined.
Measured: Baseline and at surgery (after approximately 4 to 24 weeks of treatment)
Brief Pain Inventory (BPI) scores
The Brief Pain Inventory (BPI) asks subjects to rate pain (modified to also include stiffness) over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where higher scores indicate more pain or interference. We will examine items reflecting worst pain, least pain, average pain, pain right now, and pain interference. Pain interference will be calculated as the mean score across 7 items (in Question 9). Subjects will be dichotomized at the median score using each of the above metrics, and rates of non-adherence will be calculated for subjects below vs. above the median.
Measured: Baseline (within 28 days prior to start of letrozole), Before surgery (approximately 4-24 weeks after the start of letrozole treatment), 1 year after surgery, and 3 years after surgery
Functional Assessment of Cancer Therapy- Endocrine Symptoms (FACT-ES) scores
The Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) contains (A) the Functional Assessment of Cancer Therapy- General (FACT-G) to measure physical, social, family, emotional, and functional well-being through 4 subscales, and (B) a fifth 18-item subscale to measure endocrine-related symptoms. In FACT-G, 6-7 items are queried in each subscale. FACT scales have 5 response levels ("not at all" to "very much"), where higher scores reflect increased wellness. The sum of item scores in each subscale will be calculated, multiplied by the number of items in the subscale, and divided by the number of items answered to derive a subscale score for each subject. The sum of subscale scores will yield the total FACT-G and FACT-ES score for each subject. Subjects will be dichotomized at the median scores for analysis.
Measured: Baseline (within 28 days prior to start of letrozole), Before surgery (approximately 4-24 weeks after the start of letrozole treatment), 1 year after surgery, and 3 years after surgery
Beliefs about Medication Questionnaire (BMQ) score
The Beliefs about Medication Questionnaire (BMQ) assesses patients' beliefs about their prescribed medication. BMQ items were adapted to reflect medication prescribed for cancer. Subjects will indicate their degree of agreement with each statement on a 5-point Likert scale ("strongly disagree" to "strongly agree"). The sum of scores for all items will be calculated for each subject. Subjects will be dichotomized at the median score for analysis.
Measured: Baseline (within 28 days prior to start of letrozole), Before surgery (approximately 4-24 weeks after the start of letrozole treatment), 1 year after surgery, and 3 years after surgery
Treatment Satisfaction Questionnaire for Medication (TSQM) total and domain scores for effectiveness, convenience, global satisfaction, and experience of side effects
- Change in Treatment Satisfaction Questionnaire for Medication (TSQM) total
- Change in Treatment Satisfaction Questionnaire for Medication (TSQM) for effectiveness
- Change in Treatment Satisfaction Questionnaire for Medication (TSQM) for convenience
- Change in Treatment Satisfaction Questionnaire for Medication (TSQM) for global satisfaction
Measured: Before surgery (approximately 4-24 weeks after the start of letrozole treatment), 1 year after surgery, and 3 years after surgery
Endocrine Therapy adherence pre and post surgery.
Determine the proportion of subjects who receive ≥1 wk of neoadjuvant endocrine therapy and remain adherent with prescribed adjuvant endocrine therapy at 1 and 3 years post surgery.
Measured: Baseline to 4 -12 weeks
Proportion of subjects who experience Clinical Response
Determine the proportion of subjects who experience clinical response, defined as a ≥50% decrease in the longest dimension of the primary tumor(s) measured from the start of treatment to right before surgery.
Measured: 4 to12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start13 Aug 2021
- Primary completion2 Apr 2028 (estimated)
- Study completion13 Aug 2029 (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.
- More trials run by Dartmouth-Hitchcock Medical 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
- Not applicable
- Intervention model
- Single group
- Model description
- Patients receive letrozole orally (PO) once daily (QD) for 4-16 weeks up to the day of surgery in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery. After surgery, a subset of patients start a hormone therapy (letrozole, anastrozole, or tamoxifen) and remain in the study for up to 3.5 years.
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary D Chamberlin, Dartmouth-Hitchcock Medical Center
- Investigators
- Mary D Chamberlin, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568616
- Sponsor's protocol ID
- D20148
- Other IDs
- NCI-2022-02378
- Acronym
- NAOMI
- Status last verified
- May 2026
- First submitted
- 22 Sep 2020
- Last updated
- 28 May 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 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Neoadjuvant ArOMatase Inhibitor Therapy for ER+ Breast Cancer (NAOMI)
- ClinicalTrials.gov ID
- NCT04568616
- Acronym / sponsor ID
- NAOMI / D20148
- Conditions
- Breast Cancer, ER Positive Breast Cancer
- Keywords
- Letrozole, Aromatase Inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- 2 Apr 2028 (estimated)
- Study completion
- 13 Aug 2029 (estimated)
- First posted
- 29 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.
This is a single-arm, open-label study testing the effects of neoadjuvant therapy with the aromatase inhibitor letrozole in post-menopausal women with Stage I-III ER+, HER2- breast cancer. Eligible subjects will be treated with letrozole therapy for 4 to 24 weeks prior to surgical resection of the tumor. Tumor specimens obtained at baseline (diagnostic biopsy) and at surgery (surgical specimen) will be compared using molecular analyses. A subset of subjects will be asked to provide an optional research tumor biopsy prior to treatment for molecular analysis. Subjects will be evaluated for treatment adherence and provide feedback via survey questionnaires to identify potential causes of non-adherence.
Detailed description
Approximately 70% of breast cancers express estrogen receptor alpha (ER), which is activated by estrogens and typically drives cancer cell growth. Adjuvant therapy with anti-estrogens such as tamoxifen and aromatase inhibitors (AIs) is commonly used to inhibit ER to prevent cancer (re)growth after early-stage breast tumors are surgically removed. However, ~33% of such patients (~300,000 new cases per year worldwide) will eventually develop anti-estrogen-resistant breast cancer that is metastatic or locally advanced; at this stage, the disease is almost never cured using available therapies and is uniformly fatal. Therefore, more effective treatment early in the course of disease (i.e., in the adjuvant setting, shortly after surgical removal of a tumor) has huge potential to prevent cancer regrowth. Most often, ER+ breast cancers re-emerge in the years after the end of the standard five-year anti-estrogen treatment regimen (called 'late recurrence'). Recent data indicate that continued anti-estrogen therapy in patients who remain "disease-free" after five years of anti-estrogen therapy modestly prevents cancer recurrence. However, tumor cells are detectable in bone marrow of patients who are "disease-free." Thus, antiestrogen therapy in "disease-free" patients likely suppresses the growth of undetectable tumor cells, keeping them in a "clinically dormant" state (i.e., undetectable by standard clinical methods). Little is known about how such dormant cancer cells survive. This clinical study will help identify the signaling pathways essential for the survival of clinically dormant ER+ breast cancer cells to enable the development of more effective therapies to eradicate such cells and prevent cancer recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients receive letrozole orally (PO) once daily (QD) for 4-16 weeks up to the day of surgery in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery. After surgery, a subset of patients start a hormone therapy (letrozole, anastrozole, or tamoxifen) and remain in the study for up to 3.5 years.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Letrozole 2.5mgLetrozole 2.5mg tablet administered once daily for 4 to ~12 weeks (window of + 4 weeks for surgical scheduling flexibility) final dose taken the day of surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologic documentation of invasive breast cancer by core needle or incisional biopsy. Subjects without excess baseline tumor tissue are eligible and evaluable for Primary Objective #2 (re: adherence). Excess baseline biopsy tumor tissue sufficient to make ten 5- micron sections must be available for research use for a subject to be evaluable for Primary Objective #1 (re: molecular analyses).
- The invasive cancer must be estrogen receptor alpha (ER)-positive, with ER staining present in greater than 50% of invasive cancer cells by IHC.
- The invasive cancer must be HER2-negative (IHC 0-1+, or with a FISH ratio of <1.8 if IHC is 2+ or if IHC has not been done).
- Clinical Stage I-III invasive breast cancer with the intent to treat with surgical resection of the primary tumor. Baseline tumor must be ≥0.5 cm. For the optional research biopsy (from 5 subjects), tumor must be
- ≥1 cm.
Key exclusion criteria (3 listed)
- Prior endocrine therapy for any histologically-confirmed cancer or prevention of breast cancer in the last 10 years is not allowed.
- Any other neoadjuvant therapy for breast cancer. Bisphosphonate or denosumab treatment for metabolic bone issues are allowed.
- Women who are pregnant or lactating.
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 |
|---|---|---|
| Letrozole 2.5mgAlso: FemaraAromatase Inhibitor | Drug | Treatment |
Primary outcome
Change in Tumor CPT1-alpha levels
Time frame: Baseline to 4-12 Weeks
Determine whether residual cancer cells exhibit upregulation of the fatty acid transport CPT1-alpha (compared to baseline) following neoadjuvant endocrine therapy in patients with ER+ breast cancer.
Determine subject adherence to endocrine therapy as measured via urine analysis
Time frame: Before surgery (within 14 days before surgery, or on day of surgery); approximately 1 year after surgery; and approximately 3 years after surgery
Urine analysis for drug metabolites will be used to determine subject adherence to endocrine therapy at three time points. (Protocol section 6.16.e) The outcome measure is percent of participants with adherence vs non-adherence as measured by urine samples tested for metabolites of adjuvant endocrine agents: tamoxifen, letrozole, anastrozole or exemestane. Urine tests will be recorded as positive or negative. Positive urine test = adherence.
Treatment Satisfaction Questionnaire for Medication (TSQM) side effects score
Time frame: Before surgery (approximately 4-24 weeks after the start of letrozole treatment), 1 year after surgery, and 3 years after surgery
The Treatment Satisfaction Questionnaire for Medication (TSQM) v1.4 assesses subjects' satisfaction with their breast cancer medication over the past 2-3 weeks, or since last use. A modified 12-item questionnaire will address 4 domains: effectiveness (Item 1), side effects (Items 2-6), convenience (Items 7-9), and global satisfaction (Items 10-12). Item 2 (experience of side effects; yes/no) will be evaluated independently. Subjects will be dichotomized at the median score for analysis.
8 secondary outcomes
Longest dimension(s) of primary tumor(s) pre- and post-treatment
Time frame: Baseline and after approximately 4 to 24 weeks of treatment
Altered mitochondrial and fatty acid metabolism in surgical tissue specimen as compared to baseline tissue specimen.
Time frame: Baseline and at surgery (after approximately 4 to 24 weeks of treatment)
Brief Pain Inventory (BPI) scores
Time frame: Baseline (within 28 days prior to start of letrozole), Before surgery (approximately 4-24 weeks after the start of letrozole treatment), 1 year after surgery, and 3 years after surgery
Functional Assessment of Cancer Therapy- Endocrine Symptoms (FACT-ES) scores
Time frame: Baseline (within 28 days prior to start of letrozole), Before surgery (approximately 4-24 weeks after the start of letrozole treatment), 1 year after surgery, and 3 years after surgery
Beliefs about Medication Questionnaire (BMQ) score
Time frame: Baseline (within 28 days prior to start of letrozole), Before surgery (approximately 4-24 weeks after the start of letrozole treatment), 1 year after surgery, and 3 years after surgery
Treatment Satisfaction Questionnaire for Medication (TSQM) total and domain scores for effectiveness, convenience, global satisfaction, and experience of side effects
Time frame: Before surgery (approximately 4-24 weeks after the start of letrozole treatment), 1 year after surgery, and 3 years after surgery
Endocrine Therapy adherence pre and post surgery.
Time frame: Baseline to 4 -12 weeks
Proportion of subjects who experience Clinical Response
Time frame: 4 to12 Weeks
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 28 May 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. This study is not recruiting at the moment.
Mary D Chamberlin, MD principal investigator
Dartmouth-Hitchcock Medical Center
2 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 Letrozole 2.5mg in people with Breast Cancer and ER Positive Breast Cancer, run by Dartmouth-Hitchcock Medical Center at 2 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 12 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: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Change in Tumor CPT1-alpha levels (time frame: Baseline to 4-12 Weeks). The study lists 3 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 28 May 2026.