12 Participants Needed

FES Imaging + Tamoxifen for Breast Cancer

Recruiting at 1 trial location
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Overseen Bycancer connect
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: University of Wisconsin, Madison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 5 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

Participants must stop taking any ER blocking endocrine therapies like tamoxifen at least 60 days before the study. Additionally, medications that strongly affect certain liver enzymes (CYP2D6, CYP3A4, CYP2C9) are not allowed unless they can be stopped or switched to alternatives before starting the study.

What data supports the effectiveness of the drug Tamoxifen for breast cancer?

Research shows that Tamoxifen is effective in treating metastatic breast cancer, with some patients experiencing complete or partial remission. It is also being studied for its potential to prevent breast cancer in healthy women, especially those at high risk.12345

Is the combination of FES Imaging and Tamoxifen safe for humans?

Tamoxifen, used for breast cancer treatment, is generally safe but can have side effects like a small increased risk of endometrial cancer and other gynecological issues. Regular monitoring is recommended for those taking it long-term.26789

How does the drug Tamoxifen differ from other breast cancer treatments?

Tamoxifen is unique because it acts as both an antiestrogen and an estrogen agonist, which can lead to different side effects compared to other treatments like aromatase inhibitors. It is effective in both pre- and postmenopausal women and is used not only for treatment but also for prevention of breast cancer in high-risk women.246910

What is the purpose of this trial?

Despite broad advancements in endocrine therapy for ERα+ breast cancer, resistance ultimately develops. A common driver of resistance are known ESR1 mutations that lead to constitutively active receptor signaling and transcriptional regulation that is always "turned on" despite the absence of estrogen. Patients with ESR1 mutations are expected to have decreased binding affinity for tamoxifen and thus may be underdosed on standard therapy. \[18F\]-fluoroestradiol Positron Emission Tomography/Computed tomography (FES-PET/CT) imaging is a novel functional imaging technique that can non-invasively measure ERα expression and inhibition in metastatic ERα+ breast cancer. The proposed a pilot study uses FES-PET/CT imaging to measure ERα blockade to determine the optimal dose of tamoxifen in patients with ESR1 mutations.

Research Team

Kari Wisinski | Department of Medicine ...

Kari B. Wisinski

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for individuals with metastatic or unresectable breast cancer that tests positive for estrogen receptor expression and has an ESR1 mutation. They must have had prior endocrine therapy, be stable after CNS metastases treatment, and able to take oral medications. Excluded are those with liver-only disease, recent other treatments, severe allergies to similar compounds as tamoxifen or FES-PET/CT components, certain health conditions, or concurrent malignancies.

Inclusion Criteria

I can take pills by mouth.
My cancer tests show at least 10% estrogen receptor presence.
My organs and bone marrow are functioning well.
See 10 more

Exclusion Criteria

I am aware that Tamoxifen can cause vaginal bleeding and harm to a fetus.
I do not have any unmanaged serious illnesses.
My nerve damage does not severely affect my daily activities.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tamoxifen at varying dose levels, starting within 14 days of the FES-PET/CT scan, until there is evidence of progressive disease or drug intolerance

up to 6 weeks
Regular visits for FES-PET/CT imaging and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • FES PET/CT
  • Tamoxifen
Trial Overview The study investigates the use of FES-PET/CT imaging to measure ERα blockade in order to find the optimal dose of tamoxifen for patients with ESR1 mutations. It's a pilot study aiming at improving dosing strategies by using advanced imaging techniques on participants who may not respond well to standard doses due to these specific gene mutations.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Tamoxifen Dose LevelsExperimental Treatment2 Interventions
Three participants will be enrolled to each dose level of oral tamoxifen (n = 12) Dose Level 1 = 20 mg daily Dose Level 2 = 80 mg daily Dose Level 3 = 160 mg daily Dose Level 4 = 200 mg daily Tamoxifen should be started within 14 days of the FES-PET/CT scan, at least 24 hours after FES injection. Participants will continue tamoxifen therapy until there is radiologic or clinical evidence of progressive disease or drug intolerance.

Tamoxifen is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Nolvadex for:
  • Breast cancer
  • Infertility
  • Gynecomastia
🇺🇸
Approved in United States as Tamoxifen citrate for:
  • Breast cancer
  • Reduction in breast cancer incidence in high-risk women
  • McCune-Albright Syndrome
🇨🇦
Approved in Canada as Tamoxifen for:
  • Breast cancer
  • Reduction in breast cancer incidence in high-risk women
🇯🇵
Approved in Japan as Tamoxifen for:
  • Breast cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

Findings from Research

In a study of 50 postmenopausal women with metastatic breast cancer who had not responded to previous treatments, tamoxifen citrate led to a complete remission in 8% and a partial remission in 28% of patients, with a median response duration of eight months.
Tamoxifen was found to significantly prolong survival in responders compared to nonresponders, and the side effects of the treatment were mild, making it a favorable option for patients after other therapies have failed.
Tamoxifen. Use in treatment of metastatic breast cancer refractory to combination chemotherapy.Legha, SS., Buzdar, AU., Hortobagyi, GN., et al.[2019]
Tamoxifen is being evaluated in ongoing clinical trials involving over 24,000 healthy women to determine its effectiveness in preventing breast cancer, with results expected by the year 2000.
While tamoxifen may provide significant benefits in breast cancer prevention, it is associated with adverse effects such as transient bone loss in premenopausal women and potential uterine complications in postmenopausal women, leading to investigations of alternative drugs like raloxifene and toremifene.
Status of antiestrogen breast cancer prevention trials.Powles, TJ.[2016]
Molecular imaging with 16α-[18F]fluoro-17β-estradiol (FES) and 18F-fluoro-furanyl-norprogesterone PET can effectively evaluate the function of steroid hormone receptors in breast cancer, which is crucial for understanding treatment responses.
A current multicenter trial is underway to further validate FES-PET imaging, aiming to enhance its clinical application in predicting prognosis and personalizing endocrine therapy for patients with estrogen receptor-positive tumors.
Clinical Potential of Estrogen and Progesterone Receptor Imaging.Linden, HM., Peterson, LM., Fowler, AM.[2019]

References

Tamoxifen. Use in treatment of metastatic breast cancer refractory to combination chemotherapy. [2019]
Status of antiestrogen breast cancer prevention trials. [2016]
Clinical Potential of Estrogen and Progesterone Receptor Imaging. [2019]
Aromatase inhibitors in breast cancer: an update. [2018]
Prescription of tamoxifen for breast cancer prevention by primary care physicians. [2015]
Aromatase inhibitors in the adjuvant treatment of postmenopausal women with early breast cancer: Putting safety issues into perspective. [2018]
[Monitoring women on tamoxifen ]. [2013]
The effect of tamoxifen on the endometrium. [2013]
Tamoxifen's impact on the management of breast cancer: patient perspectives. [2013]
Tamoxifen ("Nolvadex"): a review. [2019]
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