A Phase 1 interventional study of Endoxifen Hydrochloride and Placebo Administration in Breast Carcinoma In Situ, Breast Ductal Carcinoma In Situ and Breast Lobular Carcinoma In Situ, sponsored by National Cancer Institute (NCI). Active, not recruiting at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Prevention
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Among 13 studies in Carcinoma, Intraductal, Noninfiltrating by National Cancer Institute (NCI) — 3 open to participants now, 5 under way, 1 of them phase 3. Carcinoma, Intraductal, Noninfiltrating · National Cancer Institute (NCI).
Among the 13 studies in Carcinoma, Intraductal, Noninfiltrating by National Cancer Institute (NCI), this one is the 9th largest by enrollment, is one of 3 that started in 2018, is one of 5 in phase 1, and was the 9th registered.
286 studies on the registry are indexed under Carcinoma, Intraductal, Noninfiltrating; 55 are open to participants now.
Browse Carcinoma, Intraductal, Noninfiltrating studies →3 of the 13 studies in Carcinoma, Intraductal, Noninfiltrating by National Cancer Institute (NCI) are open now, in 1 country. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Ages 45–74 · Women only · Healthy volunteers
National Cancer Institute (NCI) · Sites in United States
Ages 35+ · Women only
National Cancer Institute (NCI) · Sites in United States
Ages 18–55 · Women only
By country, each count listing its studies:
Of the 42 Carcinoma, Intraductal, Noninfiltrating studies recruiting now, 33 (79%) set no upper age limit and 5 (12%) stop at 75 or younger; 1 takes children under 18; 4 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 32 is below the median of 66 across 208 interventional studies indexed under Carcinoma, Intraductal, Noninfiltrating.
Median enrollment 65 across the 13 interventional studies. Of the 8 that completed or were terminated, 6 (75%) have results posted.
This tab as a report to print or save as PDF → With an account.
National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 412 completed or terminated interventional studies of FDA-regulated products, 374 (91%) have results posted.
2 of the studies in Carcinoma, Intraductal, Noninfiltrating by National Cancer Institute (NCI) that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06195306National Cancer Institute (NCI)Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction | 2027-01-01 |
| NCT05941520National Cancer Institute (NCI)Acolbifene Versus Low Dose Tamoxifen for the Prevention of Breast Cancer in Premenopausal Women at High Risk for Development of Breast Cancer | 2027-08-23 |
Add all 2 to your calendar (.ics) → With an account.
Among the 13 studies in Carcinoma, Intraductal, Noninfiltrating by National Cancer Institute (NCI), from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This randomized phase I trial studies the side effects and best dose of endoxifen hydrochloride in treating participants who are undergoing breast surgery. Endoxifen hydrochloride may treat or reduce the risk of breast cancer.
PRIMARY OBJECTIVE:
I. To establish the dermal tolerability and safety of endoxifen hydrochloride (endoxifen [ENX]) gel administered topically to both breasts at two doses: 10 mg daily (5 mg per breast) and 20 mg daily (10 mg per breast) in comparison to vehicle placebo gel, using objective assessments based on Common Terminology Criteria for Adverse Events (CTCAE) criteria.
SECONDARY OBJECTIVES:
I. To measure the breast tissue concentrations of (E) and (Z) isomers of N-desmethyl-4-hydroxytamoxifen (ENX) and 4-hydroxytamoxifen (4-OHT) at each dose (10 mg per day and 20 mg per day).
II. To measure the plasma concentrations of (E) and (Z) isomers ENX and 4-OHT at each dose (10 mg per day and 20 mg per day).
III. To measure serum estrogenic response to topical ENX gel therapy in comparison to vehicle placebo gel (sex hormone binding globulin and insulin-like growth factor [IGF] pathway proteins).
IV. To assess changes in coagulation parameters (factor VIII, factor IX, vWF, protein S) in response to ENX gel therapy in comparison to vehicle placebo gel.
V. To assess symptoms related to use of endoxifen gel in comparison to vehicle placebo gel, as assessed by the Breast Cancer Prevention Trial (BCPT) Eight Symptom Scale (BESS) questionnaire.
EXPLORATORY OBJECTIVE:
I. Using pathological lesion-matched pre- and post-therapy tissue samples, to explore the potential therapeutic effects of the two doses of ENX gel in comparison to vehicle placebo gel: a) by IHC, Ki67 labelling (for cell proliferation), estrogen receptor (ER), progesterone receptor (PR) expression (for estrogen blockade); b) by expression of a panel of genes reported to change with ENX exposure (using nanostring assays).
OUTLINE: Participants are randomized in Cohorts 1 and 2. All subjects in Cohort 3 will receive active agent.
COHORT I: Participants apply endoxifen hydrochloride gel to both breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery.
COHORT II: Participants apply placebo to both breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery.
COHORT III: Participants apply endoxifen hydrochloride gel to both breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery.
After completion of study treatment, participants are followed up at 60 days.
286 studies on the registry are indexed under Carcinoma, Intraductal, Noninfiltrating; 55 are open to participants now.
This study's enrollment of 32 is below the median of 66 across 208 interventional studies indexed under Carcinoma, Intraductal, Noninfiltrating.
Browse Carcinoma, Intraductal, Noninfiltrating studies →National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 412 completed or terminated interventional studies of FDA-regulated products, 374 (91%) have results posted.
Compared within Carcinoma, Intraductal, Noninfiltrating, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Breast Carcinoma In Situ. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants apply endoxifen hydrochloride gel to both breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery.
Drug: Endoxifen Hydrochloride · Other: Questionnaire Administration
Participants apply placebo to both breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery.
Other: Placebo Administration · Other: Questionnaire Administration
Apply to the skin
Also known as: Z-Endoxifen HCl, Z-Endoxifen Hydrochloride
Apply to the skin
Ancillary studies
Number of Participants With Dermal Toxicity on Breast Skin at the Application Site
Number of participants with dermal toxicity on breast skin at the transdermal gel application site. Will be assessed by Common Terminology Criteria for Adverse Events version 4.
Time frame: Up to 60 days
Drug Concentration in Tissue
Concentrations of (E) and (Z) Isomers ENX in right and left breast tissue at end of intervention (up to 4 weeks) in tissue samples
Time frame: up to 28 days
Drug Concentration in Plasma
Concentration of (E) and (Z) Isomers ENX in plasma at the end of intervention (up to 4 weeks)
Time frame: baseline and up to 28 days
Change in Plasma Estrogenic and Coagulation Parameters
Change in plasma Estrogenic and Coagulation Parameters from baseline to end of intervention (up to 28 days) including: IGF1, IGFBP3, SHBG.
Time frame: baseline and up to 28 days
Change in Pre-therapy and Post-therapy Symptoms Captured by BESS Questionnaire
Assessed using the Breast Cancer Prevention Trial (BCPT) Eight Symptom Scale (BESS) questionnaire. A patient reported outcome, subscale 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.
Time frame: baseline and up to 60 days
| Milestone | Endoxifen Hydrochloride Gel 10 mg Daily | Endoxifen Hydrochloride Gel 20 mg Daily | Placebo |
|---|---|---|---|
| Started | 16 | 8 | 8 |
| Completed | 15 | 7 | 7 |
| Not completed | 1 | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
| Withdrew: Physician decision | 0 | 0 | 1 |
| Withdrew: Surgery rescheduled | 0 | 1 | 0 |
Number of participants with dermal toxicity on breast skin at the transdermal gel application site. Will be assessed by Common Terminology Criteria for Adverse Events version 4.
| Participants | Endoxifen Hydrochloride Gel 10 mg Daily | Endoxifen Hydrochloride Gel 20 mg Daily | Placebo |
|---|---|---|---|
| Number of Participants With Dermal Toxicity on Breast Skin at the Application Site | 4 | 2 | 0 |
Concentrations of (E) and (Z) Isomers ENX in right and left breast tissue at end of intervention (up to 4 weeks) in tissue samples
| ng/g | Endoxifen Hydrochloride Gel 10 mg Daily | Endoxifen Hydrochloride Gel 20 mg Daily | Placebo |
|---|---|---|---|
| Central Subareolar Left Breast Z_ENX | 0.47 (0.15 to 0.79) | 0.76 (0.65 to 1.01) | 0.00 (0.00 to 0.00) |
| Central Subareolar Left Breast E_ENX | 0.16 (0.16 to 0.28) | 0.25 (0.16 to 0.39) | 0.00 (0.00 to 0.00) |
| Central Subareolar Right Breast Z_ENX | 0.37 (0.15 to 0.44) | 1.00 (0.62 to 1.51) | 0.00 (0.00 to 0.00) |
| Central Subareolar Right Breast E_ENX | 0.16 (0.16 to 0.16) | 0.30 (0.16 to 0.58) | 0.00 (0.00 to 0.08) |
| Central Deepest Left Breast Z_ENX | 0.40 (0.15 to 1.73) | 1.55 (0.34 to 2.85) | 0.00 (0.00 to 0.00) |
| Central Deepest Left Breast E_ENX | 0.16 (0.16 to 1.39) | 0.91 (0.16 to 1.78) | 0.00 (0.00 to 0.16) |
| Central Deepest Right Breast Z_ENX | 0.46 (0.15 to 1.58) | 2.57 (1.3 to 15.06) | 0.00 (0.00 to 0.100) |
| Central Deepest Right Breast E_ENX | 0.28 (0.16 to 1.69) | 1.70 (1.13 to 17.20) | 0.00 (0.00 to 0.00) |
| Lateral Surface Left Breast Z_ENX | 0.34 (0.15 to 0.75) | 0.81 (0.58 to 1.00) | 0.00 (0.00 to 0.00) |
| Lateral Surface Left Breast E_ENX | 0.16 (0.16 to 0.50) | 0.27 (0.16 to 0.42) | 0.00 (0.00 to 0.00) |
| Lateral Surface Right Breast Z_ENX | 0.45 (0.15 to 1.38) | 1.20 (0.99 to 1.27) | 0.00 (0.00 to 0.08) |
| Lateral Surface Right Breast E_ENX | 0.16 (0.16 to 1.12) | 0.39 (0.16 to 0.47) | 0.00 (0.00 to 0.00) |
Concentration of (E) and (Z) Isomers ENX in plasma at the end of intervention (up to 4 weeks)
| ng/ml | Endoxifen Hydrochloride Gel 10 mg | Endoxifen Hydrochloride Gel 20 mg | Placebo |
|---|---|---|---|
| Z_ENX | 0.15 (0.15 to 0.15) | 0.44 (0.15 to 0.54) | 0.00 (0.00 to 0.00) |
| E_ENX | 0.00 (0.00 to 0.00) | 0.00 (0.00 to 0.00) | 0.00 (0.00 to 0.00) |
Change in plasma Estrogenic and Coagulation Parameters from baseline to end of intervention (up to 28 days) including: IGF1, IGFBP3, SHBG.
| ng/ml | Endoxifen Hydrochloride Gel 10 mg Daily | Endoxifen Hydrochloride Gel 20 mg | Placebo |
|---|---|---|---|
| IGF1 | -1.7 (-9.9 to 6.6) | 3.0 (-8.6 to 15) | -1.0 (-17 to 15) |
| IGFBP3 | 48 (-29 to 125) | -2.5 (-216 to 211) | -60 (-205 to 84) |
| SHBG | -9.4 (-26 to 6.8) | 1.9 (-13 to 17) | -4.4 (-12 to 3.8) |
Assessed using the Breast Cancer Prevention Trial (BCPT) Eight Symptom Scale (BESS) questionnaire. A patient reported outcome, subscale 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.
| change in score on a scale | Endoxifen Hydrochloride Gel 10 mg Daily | Endoxifen Hydrochloride Gel 20 mg Daily | Placebo |
|---|---|---|---|
| Cognitive | -0.16 (-0.60 to 0.29) | -0.05 (-1.0 to 0.88) | -0.19 (-0.62 to 0.24) |
| Body Pain | -0.18 (-0.44 to 0.08) | -0.38 (-1.2 to 0.48) | -0.10 (-0.73 to 0.54) |
| Vasomotor | -0.02 (-0.26 to 0.21) | -0.05 (-0.16 to 0.07) | 0.19 (-0.64 to 1.0) |
| Gastrointestinal | -0.07 (-0.19 to 0.06) | -0.24 (-0.53 to 0.06) | 0.10 (-0.20 to 0.39) |
| Sexual Problems | 0.13 (-0.15 to 0.42) | -0.57 (-1.8 to 0.64) | -0.29 (-0.74 to 0.17) |
| Body Image | -0.20 (-0.54 to 0.14) | -0.64 (-1.3 to 0.00) | -0.43 (-1.4 to 0.55) |
| Vaginal | 0.13 (-0.21 to 0.47) | -0.29 (-0.77 to 0.20) | -0.24 (-0.53 to 0.06) |
| Bladder Problem | 0.03 (-0.04 to 0.10) | -0.86 (-1.8 to 0.06) | 0.07 (-0.10 to 0.25) |
Collected over AEs collected from the time informed consent was signed and baseline procedures were completed through 60 days post-intervention. In total AEs collected for a period of up to 3 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Endoxifen Hydrochloride Gel 10 mg Daily | 0/16 (0%) | 0/16 (0%) | 7/16 (43.8%) |
| Endoxifen Hydrochloride Gel 20 mg Daily | 0/8 (0%) | 0/8 (0%) | 3/8 (37.5%) |
| Placebo | 0/8 (0%) | 0/8 (0%) | 5/8 (62.5%) |
| Event | Endoxifen Hydrochloride Gel 10 mg Daily | Endoxifen Hydrochloride Gel 20 mg Daily | Placebo |
|---|---|---|---|
| General disorders and administration site conditions - Other, specifyGeneral disorders | 4/16 | 3/8 | 1/8 |
| Hot flashesVascular disorders | 1/16 | 1/8 | 3/8 |
| HyperhidrosisSkin and subcutaneous tissue disorders | 2/16 | 0/8 | 2/8 |
| FatigueGeneral disorders | 0/16 | 0/8 | 1/8 |
| InsomniaPsychiatric disorders | 0/16 | 0/8 | 1/8 |
| Breast painReproductive system and breast disorders | 1/16 | 1/8 | 1/8 |
| Vaginal InfectionsInfections and infestations | 1/16 | 0/8 | 0/8 |
| NauseaGastrointestinal disorders | 1/16 | 0/8 | 0/8 |
| HeadacheNervous system disorders | 1/16 | 0/8 | 0/8 |
Women who are scheduled for mastectomy, either for risk reduction, or for breast cancer or DCIS therapy.
| Age, Categorical(Participants) | Endoxifen Hydrochloride Gel 10 mg Daily | Endoxifen Hydrochloride Gel 20 mg Daily | Placebo | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 16 | 8 | 8 | 32 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Endoxifen Hydrochloride Gel 10 mg Daily | Endoxifen Hydrochloride Gel 20 mg Daily | Placebo | Total |
|---|---|---|---|---|
| Female | 16 | 8 | 8 | 32 |
| Male | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Endoxifen Hydrochloride Gel 10 mg Daily | Endoxifen Hydrochloride Gel 20 mg Daily | Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 1 | 3 |
| Not Hispanic or Latino | 13 | 7 | 7 | 27 |
| Unknown or Not Reported | 2 | 0 | 0 | 2 |
| Race (NIH/OMB)(Participants) | Endoxifen Hydrochloride Gel 10 mg Daily | Endoxifen Hydrochloride Gel 20 mg Daily | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 3 | 0 | 1 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 2 | 3 |
| White | 11 | 6 | 5 | 22 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 1 | 0 | 3 |
| Region of Enrollment(participants) | Endoxifen Hydrochloride Gel 10 mg Daily | Endoxifen Hydrochloride Gel 20 mg Daily | Placebo | Total |
|---|---|---|---|---|
| United States | 16 | 8 | 8 | 32 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2018 to primary completion in Feb 2021, 27 months.
Results were first posted in Jun 2023, 2 years 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Endoxifen hydrochloride
Carcinoma, Intraductal, Noninfiltrating →
National Cancer Institute (NCI) →