Endocrine Therapy for Metastatic Lobular Breast Cancer
Biomarkers to Detect Endocrine Therapy Resistance
Recruiting
Phase 2
Interventional Study
Metastatic Cancer
Breast Cancer
Lobular Breast Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 8 (estimated)
- Sponsor
- University of Wisconsin, Madison · Other
Who this trial is looking for
This trial is looking for women with advanced lobular breast cancer who are starting a new hormone therapy. Participants will have tests done before and after treatment to see how well the therapy is working.
Are You a Good Fit for This Trial?
You may be able to join if
- I am at least 18 years old
- I have been diagnosed with ER/PR-positive advanced lobular breast cancer
- I am starting new standard hormone therapy
- I have good organ function as determined by my doctor
- I can comply with all study procedures
- I have measurable or evaluable cancer
- I have lytic or mixed lytic-sclerotic bone lesions
You may not be able to join if
- I have active brain metastases
- I have liver-only disease
- I cannot lie flat or tolerate a PET/CT scan
- I have a history of allergic reactions to similar compounds
- I have liver failure as judged by my doctor
- I am pregnant, breastfeeding, or planning to become pregnant
- I have progesterone-receptor negative disease
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
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About This Trial
This pilot observational study is being done to identify possible biomarkers of response to endocrine therapy in patients with ER/PR+ metastatic lobular breast cancer (LBC) starting new endocrine therapy. 18F-fluorofuranylnorprogesterone Positron Emission Tomography/Computed Tomography (FFNP-PET/CT) and liquid biopsies will be performed at baseline and after 4 weeks of treatment. Baseline levels a…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Willing to provide informed consent
2. Individuals at least 18 years of age
3. Have biopsy-proven ER/PR-positive (defined as ER ≥1 percent and PR ≥1 percent by IHC) and HER2-negative advanced or metastatic LBC starting new standard of care endocrine therapy
4. Adequate organ …
Contacts