Ductal Breast Carcinoma In SituPhase 2NCT02993159
Testing an Active Form of Tamoxifen (4-hydroxytamoxifen) Delivered Through Breast Skin to Control Ductal Carcinoma in Situ (DCIS) of the Breast
A Phase 2 study testing Afimoxifene, Laboratory Biomarker Analysis and Tamoxifen Citrate in people with Ductal Breast Carcinoma In Situ and Estrogen Receptor Positive, run by Northwestern University at 6 sites in United States.
Trial summary
This randomized phase IIB trial studies how well tamoxifen or afimoxifene works in treating patients with estrogen receptor positive breast cancer. Estrogen can cause the growth of breast cancer cells. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ductal Breast Carcinoma In Situ, Estrogen Receptor Positive
- What is being tested?
- Afimoxifene, Laboratory Biomarker Analysis and Tamoxifen Citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 6 sitesUnited States
- Study dates
- 31 May 2017to 24 Jan 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Screen-detected, estrogen receptor (ER) positive DCIS of the breast proven on core needle biopsy, defined as 10% positive cells; the presence of a focus suspicious for microinvasion will be allowed; the size of the DCIS in the core biopsy sample must total 5 mm (multiple cores can be summed) and must be estimated on the deepest step section (if step sections are taken)
- Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
- Participants must have acceptable organ and marrow function as defined below:
- Baseline lab parameters are not standard of care for initiation of tamoxifen therapy; a minimal panel will therefore be appropriate.
- Leukocytes >= 3,000/microliter
- Absolute neutrophil count >= 1,500/microliter
Show all 13Show fewer
- Platelets >= 100,000/microliter
- Total bilirubin within "≤1.5 x institutional upper limit of normal (ULN)institutional limits
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 x institutional upper limit of normal (ULN)
- Creatinine within "≤1.5 x institutional upper limit of normal (ULN) institutional limits
- Women of childbearing potential and their male partners must agree to use TWO effective forms of birth control (abstinence is not an allowed method) prior to study entry and for the duration of study participation, and for two months following the last dose of study medications; effective birth control methods are: copper IUD [intrauterine device], diaphragm/cervical cap/shield, spermicide, contraceptive sponge, condoms; women of childbearing potential must have a negative urine pregnancy test within seven days before starting study medications; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
- Willingness to avoid exposing breast skin to natural or artificial sunlight (i.e. tanning beds) for the duration of the study
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- DCIS presentation as a palpable mass
- Exogenous sex steroid use within 4 weeks prior to core needle biopsy
- Prior ipsilateral breast cancer radiotherapy will be excluded; prior contralateral breast cancer therapy within 2 years will also be excluded
- Skin lesions on the breast that disrupt the stratum corneum (eg eczema, ulceration)
- History of endometrial neoplasia
- History of thromboembolic disease (history of varicose veins and superficial phlebitis is allowed)
Show all 14Show fewer
- Current smokers
- Current users of potent inhibitors of tamoxifen metabolism must be able to discontinue their use and switch to an alternative medication for the duration of participation, under the advice of their physician; if the physician feels that an alternative medication is not appropriate for the subject and the current medication is medically necessary, the subject will not be eligible; the drugs are listed below; many of these are not in clinical use at the moment; bupropion, celecoxib, chlorpheniramine, chlorpromazine, cimetidine, citalopram, clemastine, clomipramine, clozapine, cocaine, delavirdine, desipramine, diphenhydramine, doxepin, duloxetine, escitalopram, fluoxetine, haloperidol, halofantrine, hydroxyzine, imipramine, isoniazid, ketoconazole, methadone, methimazole, mibefradil, miconazole, nicardipine, paroxetine, pergolide, perphenazine, pioglitazone, pyrimethamine, quinidine, quinine, ranitidine, ritonavir, ropinirole, sertraline, terbinafine, thioridazine, ticlopidine, tranylcypromine, trazodone, tripelennamine
- Prior use of SERMS or AIs including tamoxifen, raloxifene, anastrozole, letrozole, or exemestane for prevention or therapy within 5 years
- Participants may not be receiving any other investigational agents within 30 days of enrollment or during this study
- History of allergic reactions attributed to tamoxifen or compounds of similar chemical or biologic composition
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study; breastfeeding should be discontinued by nursing mothers who agree to participate in the study
- Men are excluded from this study since DCIS of the breast is exceedingly rare in men, and there are no data regarding skin penetration of 4-OHT though male chest wall skin (which is thicker and hairier than female chest wall skin)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Northwestern University
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44106
Duke University Medical Center
Durham, North Carolina, 27710
Saint Elizabeth Medical Center South
Edgewood, Kentucky, 41017
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Phase IIB Pre-Surgical Trial of Oral Tamoxifen Versus Transdermal 4-hydroxytamoxifen in Women With DCIS of the Breast
This randomized phase IIB trial studies how well tamoxifen or afimoxifene works in treating patients with estrogen receptor positive breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate or afimoxifene may fight breast cancer by blocking the use of estrogen by the tumor cells.
Read the detailed description
PRIMARY OBJECTIVES:
- To demonstrate that 2 mg once daily per breast of 4-hydroxytamoxifen (4-OHT) topical gel results in a reduction in the Ki-67 labeling index of ductal breast carcinoma in situ (DCIS) lesions that is not inferior to that seen with 20 mg daily oral tamoxifen citrate (TAM) for 4-10 weeks, when comparing the base-line diagnostic core biopsy to the therapeutic surgical excision sample.
SECONDARY OBJECTIVES:
- To compare post-therapy changes in the oncotype DCIS-score between arms (this is a validated reverse transcriptase-polymerase chain reaction [RT-PCR] assay for Ki67, STK15, survivin, cyclin B1, MYBL2, PR, GSTM1).
II. To compare between-group post-therapy changes in immunohistochemistry (IHC) markers: CD-68 macrophage marker as a surrogate for response to therapy, p16 and COX-2.
III. To compare post-therapy changes in breast density, quantitative estimate, between arms.
IV. To compare post-therapy breast tissue and plasma levels of TAM and its metabolites (N-desmethyl tamoxifen [NDT], [E] and [Z] isomers of 4-hydroxytamoxifen [4-OHT], N-desmethyl-4-hydroxytamoxifen [endoxifen]).
- To compare post-therapy breast tissue and plasma levels of estradiol and progesterone between arms (optional).
VI. To compare the post-therapy fraction of participants demonstrating "no residual DCIS".
VII. To compare post-therapy changes in plasma proteins involved in coagulation: factors VIII and IX, von Willebrand factor, total protein S between arms.
VIII. To compare post-therapy changes in plasma markers of systemic estrogenic effect (IGF-1, SHBG).
IX. To compare post-therapy changes in symptoms as captured in the breast cancer prevention trial (BCPT) Eight Symptom Scale (BESS) questionnaire and skin reactions to 4-OHT gel.
OUTLINE: Patients are randomized into 1 of 2 arms.
ARM I: Patients apply afimoxifene gel to both breasts and receive placebo orally (PO) daily for 4-10 weeks in the absence of disease progression or unexpected toxicity.
ARM II: Patients apply placebo gel to both breasts and receive tamoxifen citrate orally PO daily for 4-10 weeks in the absence of disease progression or unexpected toxicity.
After completion of study treatment, patients are followed up at 1-2 weeks and 1 month after surgery.
- Being tested
- Afimoxifene, Laboratory Biomarker Analysis, Placebo, Tamoxifen Citrate
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfimoxifeneDrug
Also called 4-Hydroxy-Tamoxifen, 4-Hydroxytamoxifen, 4-OHT
Applied to the breast
Laboratory Biomarker AnalysisOther
Correlative studies
PlaceboOther
Also called placebo therapy, PLCB, sham therapy
Given PO
PlaceboOther
Also called placebo therapy, PLCB, sham therapy
Applied to the breast
Tamoxifen CitrateDrug
Also called Apo-Tamox, Clonoxifen, Dignotamoxi, Ebefen
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I (afimoxifene, placebo) | Experimental | Patients apply afimoxifene gel to both breasts and receive placebo PO daily for 4-10 weeks in the absence of disease progression or unexpected toxicity. Receives: Drug: Afimoxifene; Other: Laboratory Biomarker Analysis; Other: Placebo |
| Arm II (placebo, tamoxifen citrate) | Active comparator | Patients apply placebo gel to both breasts and receive tamoxifen citrate orally PO daily for 4-10 weeks in the absence of disease progression or unexpected toxicity. Receives: Other: Laboratory Biomarker Analysis; Other: Placebo; Drug: Tamoxifen Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ki-67 Labeling Index
Change in the Ki-67 labelling index of DCIS lesions evaluated using immunohistochemistry
Measured: baseline to up to 10 weeks
Secondary outcomes (8)
Change in Oncotype DCIS-Score
Change in Exact Sciences Oncotype Diagnosis Breast Ductal Carcinoma in Situ Score (Oncotype DCIS-Score), a clinical validated clinically validated, commercially available genomic test for patients with DCIS. Oncotype DCIS-Score Range is 0-100. A negative change in scores indicates a lower risk of recurrence (better outcome).
Measured: baseline to up to 10 weeks
Post-therapy Breast Tissue Levels of Tamoxifen and Its Metabolites
Post-therapy concentrations of 4-OHT and endoxifen in breast tissue samples
Measured: up to 10 weeks
Post-therapy Plasma Levels of Tamoxifen and Its Metabolites
Post-therapy concentrations of 4-OHT and endoxifen in plasma samples
Measured: up to 10 weeks
Ki-67 Labelling Index in the Terminal Duct Lobular Units (TDLUs)
Mean change in Ki-67 labelling index in the terminal duct lobular units (TDLUs)
Measured: baseline to up to 10 weeks
Change in Plasma Proteins Involved in Coagulation
Mean change in percentage of plasma proteins involved in coagulation: Factor VIII, Factor IX, von Willebrand Factor, and total protein S
Measured: baseline to up to 10 weeks
Change in Plasma Markers of Systemic Estrogenic Effect (SHBG)
Mean change in plasma markers of systemic estrogenic effect: SHBG.
Measured: baseline to up to 10 weeks
Change in Plasma Markers of Systemic Estrogenic Effect (IGF-1)
Mean change in plasma markers of systemic estrogenic effect: IGF-1
Measured: baseline to up to 10 weeks
Change in Symptoms as Captured in the Breast Cancer Prevention Trial (BCPT) Eight Symptom Scale (BESS) Questionnaire and Skin Reactions to 4-OHT Gel.
Mean change in symptoms as captured using the Breast Cancer Prevention Trial (BCPT) Eight Symptom Scale (BESS) questionnaire. A patient reported outcome, scores range from 0 (Not at All) to 4 (Extremely) when asked about experiencing symptoms. A positive change in scores indicates an increase in symptoms experienced and a negative change in scores indicates a decrease in symptoms experienced
Measured: baseline to up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study start31 May 2017
- Primary completion30 Mar 2021
- Study completion24 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ductal Breast Carcinoma In SituStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), BHR Pharma, LLC
- Responsible party
- Sponsor
- Investigators
- Seema Khan, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993159
- Sponsor's protocol ID
- NCI 2015-06-04
- Other IDs
- P30CA060553, NCI-2016-01911, N01-CN-2012-00035, NCI 2015-06-04, NWU2015-06-04, N01CN00035
- Status last verified
- Sep 2024
- First submitted
- 14 Dec 2016
- Last updated
- 18 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Khan SA, Mi X, Xu Y, Blanco LZ Jr, Akasha AM, Pilewskie M, Degnim AC, AlHilli Z, Amin AL, Hwang ES, Guenther JM, Kocherginsky M, Benante K, Zhang S, Helland T, Hustad SS, Gursel DB, Mellgren G, Dimond E, Perloff M, Heckman-Stoddard BM, Lee O. Presurgical Oral Tamoxifen vs Transdermal 4-Hydroxytamoxifen in Women With Ductal Carcinoma In Situ: A Randomized Clinical Trial. JAMA Surg. 2023 Dec 1;158(12):1265-1273. doi: 10.1001/jamasurg.2023.5113.
PubMed 37870954
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIB Pre-Surgical Trial of Oral Tamoxifen Versus Transdermal 4-hydroxytamoxifen in Women With DCIS of the Breast
- ClinicalTrials.gov ID
- NCT02993159
- Acronym / sponsor ID
- NCI 2015-06-04
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), BHR Pharma, LLC
- Study start
- 31 May 2017 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 24 Jan 2022 (actual)
- First posted
- 15 Dec 2016 (estimated)
- Results
- Posted 18 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase IIB trial studies how well tamoxifen or afimoxifene works in treating patients with estrogen receptor positive breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate or afimoxifene may fight breast cancer by blocking the use of estrogen by the tumor cells.
Detailed description
PRIMARY OBJECTIVES:
- To demonstrate that 2 mg once daily per breast of 4-hydroxytamoxifen (4-OHT) topical gel results in a reduction in the Ki-67 labeling index of ductal breast carcinoma in situ (DCIS) lesions that is not inferior to that seen with 20 mg daily oral tamoxifen citrate (TAM) for 4-10 weeks, when comparing the base-line diagnostic core biopsy to the therapeutic surgical excision sample.
SECONDARY OBJECTIVES:
- To compare post-therapy changes in the oncotype DCIS-score between arms (this is a validated reverse transcriptase-polymerase chain reaction [RT-PCR] assay for Ki67, STK15, survivin, cyclin B1, MYBL2, PR, GSTM1).
II. To compare between-group post-therapy changes in immunohistochemistry (IHC) markers: CD-68 macrophage marker as a surrogate for response to therapy, p16 and COX-2.
III. To compare post-therapy changes in breast density, quantitative estimate, between arms.
IV. To compare post-therapy breast tissue and plasma levels of TAM and its metabolites (N-desmethyl tamoxifen [NDT], [E] and [Z] isomers of 4-hydroxytamoxifen [4-OHT], N-desmethyl-4-hydroxytamoxifen [endoxifen]).
- To compare post-therapy breast tissue and plasma levels of estradiol and progesterone between arms (optional).
VI. To compare the post-therapy fraction of participants demonstrating "no residual DCIS".
VII. To compare post-therapy changes in plasma proteins involved in coagulation: factors VIII and IX, von Willebrand factor, total protein S between arms.
VIII. To compare post-therapy changes in plasma markers of systemic estrogenic effect (IGF-1, SHBG).
IX. To compare post-therapy changes in symptoms as captured in the breast cancer prevention trial (BCPT) Eight Symptom Scale (BESS) questionnaire and skin reactions to 4-OHT gel.
OUTLINE: Patients are randomized into 1 of 2 arms.
ARM I: Patients apply afimoxifene gel to both breasts and receive placebo orally (PO) daily for 4-10 weeks in the absence of disease progression or unexpected toxicity.
ARM II: Patients apply placebo gel to both breasts and receive tamoxifen citrate orally PO daily for 4-10 weeks in the absence of disease progression or unexpected toxicity.
After completion of study treatment, patients are followed up at 1-2 weeks and 1 month after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (afimoxifene, placebo) | Experimental | Drug: Afimoxifene, Other: Laboratory Biomarker Analysis, Other: PlaceboPatients apply afimoxifene gel to both breasts and receive placebo PO daily for 4-10 weeks in the absence of disease progression or unexpected toxicity. |
| Arm II (placebo, tamoxifen citrate) | Active comparator | Other: Laboratory Biomarker Analysis, Other: Placebo, Drug: Tamoxifen CitratePatients apply placebo gel to both breasts and receive tamoxifen citrate orally PO daily for 4-10 weeks in the absence of disease progression or unexpected toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Screen-detected, estrogen receptor (ER) positive DCIS of the breast proven on core needle biopsy, defined as 10% positive cells; the presence of a focus suspicious for microinvasion will be allowed; the size of the DCIS in the core biopsy sample must total 5 mm (multiple cores can be summed) and must be estimated on the deepest step section (if step sections are taken)
- Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
- Participants must have acceptable organ and marrow function as defined below:
- Baseline lab parameters are not standard of care for initiation of tamoxifen therapy; a minimal panel will therefore be appropriate.
- Leukocytes >= 3,000/microliter
Key exclusion criteria (14 listed)
- DCIS presentation as a palpable mass
- Exogenous sex steroid use within 4 weeks prior to core needle biopsy
- Prior ipsilateral breast cancer radiotherapy will be excluded; prior contralateral breast cancer therapy within 2 years will also be excluded
- Skin lesions on the breast that disrupt the stratum corneum (eg eczema, ulceration)
- History of endometrial neoplasia
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 |
|---|---|---|
| AfimoxifeneAlso: 4-Hydroxy-Tamoxifen, 4-Hydroxytamoxifen, 4-OHTApplied to the breast | Drug | Arm I (afimoxifene, placebo) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (afimoxifene, placebo), Arm II (placebo, tamoxifen citrate) |
| PlaceboAlso: placebo therapy, PLCB, sham therapyGiven PO | Other | Arm I (afimoxifene, placebo) |
| PlaceboAlso: placebo therapy, PLCB, sham therapyApplied to the breast | Other | Arm II (placebo, tamoxifen citrate) |
| Tamoxifen CitrateAlso: Apo-Tamox, Clonoxifen, Dignotamoxi, EbefenGiven PO | Drug | Arm II (placebo, tamoxifen citrate) |
Primary outcome
Change in Ki-67 Labeling Index
Time frame: baseline to up to 10 weeks
Change in the Ki-67 labelling index of DCIS lesions evaluated using immunohistochemistry
8 secondary outcomes
Change in Oncotype DCIS-Score
Time frame: baseline to up to 10 weeks
Post-therapy Breast Tissue Levels of Tamoxifen and Its Metabolites
Time frame: up to 10 weeks
Post-therapy Plasma Levels of Tamoxifen and Its Metabolites
Time frame: up to 10 weeks
Ki-67 Labelling Index in the Terminal Duct Lobular Units (TDLUs)
Time frame: baseline to up to 10 weeks
Change in Plasma Proteins Involved in Coagulation
Time frame: baseline to up to 10 weeks
Change in Plasma Markers of Systemic Estrogenic Effect (SHBG)
Time frame: baseline to up to 10 weeks
Change in Plasma Markers of Systemic Estrogenic Effect (IGF-1)
Time frame: baseline to up to 10 weeks
Change in Symptoms as Captured in the Breast Cancer Prevention Trial (BCPT) Eight Symptom Scale (BESS) Questionnaire and Skin Reactions to 4-OHT Gel.
Time frame: baseline to up to 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37870954Khan SA, Mi X, Xu Y, Blanco LZ Jr, Akasha AM, Pilewskie M, Degnim AC, AlHilli Z, Amin AL, Hwang ES, Guenther JM, Kocherginsky M, Benante K, Zhang S, Helland T, Hustad SS, Gursel DB, Mellgren G, Dimond E, Perloff M, Heckman-Stoddard BM, Lee O. Presurgical Oral Tamoxifen vs Transdermal 4-Hydroxytamoxifen in Women With Ductal Carcinoma In Situ: A Randomized Clinical Trial. JAMA Surg. 2023 Dec 1;158(12):1265-1273. doi: 10.1001/jamasurg.2023.5113.
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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.
Seema Khan, MD principal investigator
Northwestern University
6 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 Afimoxifene, Laboratory Biomarker Analysis and Tamoxifen Citrate in people with Ductal Breast Carcinoma In Situ and Estrogen Receptor Positive, run by Northwestern University at 6 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 13 inclusion and 14 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: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Yes. Results are posted in the registry (first posted 18 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Ki-67 Labeling Index (time frame: baseline to up to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02993159, which also lists 1 linked publication.
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 18 Dec 2024.