Tamoxifen study aims to unlock breast cancer treatment clues
NCT ID NCT01027416
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This completed pilot study looked at how the drug tamoxifen affects breast cancer tumors at a molecular level. Researchers studied 59 patients with a specific type of breast cancer to see how tamoxifen changes the interaction between two key proteins. The goal was to gather information that could eventually help doctors choose the right treatment for future patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tamoxifen
- What this could lead to
- If successful, this research could help doctors better predict which breast cancer patients will benefit from tamoxifen therapy.
- What could go wrong
- This is a small, early-stage pilot study with only 59 participants, so results may not apply to all patients. The findings are exploratory and not yet ready to change treatment.
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
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
59 people
The number who actually took part.
- Started
-
Dec 2009
- Finished
-
Dec 2015
- Lead sponsor
-
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
-
18 years and older
- Sex
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Female participants only
- Healthy volunteers
-
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: 1. The patient must consent to be in the study and must have signed an approved consent form conforming to institutional guidelines 2. The patient must be 18 years or older. 3. Core biopsy should definitively demonstrate invasive carcinoma. 4. Invasive carcinoma should be ER-apha receptor positive 5. The tumor should be approximately at least 1 cm, to account for variability in imaging and imaging occult disease (physical exam, mammography, ultrasound). We recognize that from time to time because of this variation, there might not be enough tissue available for analysis after surgical excision but this will allow the greatest opportunity to capture as many eligible patients as possible. 6. Patients in whom surgical excision of the tumor is part of standard of care management 7. ECOG score of 0 or 1 8. Negative serum or urine beta-hCG pregnancy test at screening for patients of child-bearing potential (this is routinely done if the patient is premenopausal and having surgery) 9. Consent to participate in DBBR (RPCI only) Exclusion Criteria: 1. Male patients are not eligible for this study 2. Female patients with inoperable tumors or women with stage 4 disease diagnosed on CT, PET, PET/CT or bone scan. 3. Patients with diagnosis by FNA cytology only 4. Pregnant or lactating women 5. Prior therapy for breast cancer, including irradiation, chemo- immuno- and/or hormonal therapy 6. Patients receiving any hormonal therapy, e.g. ovarian hormonal replacement therapy, infertility medications etc., are not eligible 7. Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude the patient from being subjected to surgical excision 8. Psychiatric or addictive disorders that would preclude obtaining informed consent 9. Patients known or suspected to have hypercoagulable syndrome or with history of venous or arterial thrombosis, stroke, TIA, or pulmonary embolism 10. Women with non-invasive disease or microinvasion are not eligible. 11. Women undergoing neoadjuvant chemotherapy are not eligible 12. women currently on tamoxifen and raloxifene for prevention are not eligible 13. Patients shall not receive any herbal/alternative therapies such as flaxseed or soy products or black cohosh. 14. Patients with a known mutation in p53 (Li Fraumeni Syndrome)
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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.
Contacts and locations
Locations
-
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
-
University of Chicago
Chicago, Illinois, 60601, United States
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Other studies related to the condition(s) this trial covers.
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