Could a breast cancer drug stop pancreatic cysts from becoming cancer?
NCT ID NCT06320990
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests whether tamoxifen, a drug commonly used for breast cancer, can shrink or stabilize pre-cancerous pancreatic cysts in women. The goal is to see if taking tamoxifen for up to 24 weeks can delay or eliminate the need for surgery. The study will enroll 15 women who are not planning immediate surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 19 years * Clinically diagnosed pre-invasive pancreatic mucinous cystic neoplasm (MCN), measurable by cross-sectional imaging * Surgical resection of the lesion is not planned due to cyst features, patient factors or patient preference * Females of reproductive potential and males with partners of reproductive potential must agree to employ two methods contraception throughout the study and for up to 3 months following treatment. Non-child-bearing potential is defined as age 45 years or older and no menses for greater than or equal to 12 months or any age with surgical removal of the uterus and/or both ovaries. * Estimated glomerular filtration rate (eGFR) \> 30mL/min/1.73m2 * Willing and able to provide informed consent to and abide by the protocol Exclusion Criteria: * Presence of invasive pancreatic adenocarcinoma or high-grade dysplasia * Presence of a solid component or mural nodule, main pancreatic duct dilation or abrupt caliber change, obstructive jaundice, lymphadenopathy * Current or prior use of tamoxifen or another estrogen antagonist including, but not limited to, clomifene, raloxifene, fulvestrant, anastrazole; subjects who have previously used an estrogen antagonist are eligible provided the last use was at least 5 years prior to enrollment. * Current or planned use of hormonal treatments including estrogen, progesterone, androgens, hormone replacement therapy or other types of hormonal contraceptives including implants and depot injections; levonorgestrel-releasing intrauterine device (IUD) is permitted. * Contraindications to tamoxifen include: * Pregnancy or nursing * Known allergy or hypersensitivity to tamoxifen * Cataracts which affect visual acuity (ie. symptomatic) * Retinopathy which affects visual acuity (ie. symptomatic) * Current warfarin use * History of deep vein thrombosis or pulmonary embolism or other condition which, in the opinion of the investigator, may significantly increase the individual's risk of venous thromboembolism * History of stroke * Known endometrial hyperplasia or personal history of endometrial carcinoma, uterine sarcoma and uterine carcinosarcoma * History of intestinal disease or major gastric surgery likely to alter absorption of tamoxifen or inability to swallow oral medications * Uncontrolled illness including but not limited to ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure, unstable angina or uncontrolled cardiac arrhythmias, or other conditions which might jeopardize or preclude the ability of the patient to take tamoxifen or the safety of follow-up visits, scans and procedures * Elective surgery planned for the study period * Participation in another clinical study with an investigational product during the last 28 days * Any participant, in the opinion of the investigator, who will not be able to tolerate treatment, or the participant is unsuitable to participate in the study and is unlikely to comply with study procedures, restrictions and requirements
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Nebraska Medical Center
RECRUITINGOmaha, Nebraska, 68198, United States
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Other studies related to the condition(s) this trial covers.
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