Umbrella Trial of Subtype-Targeted Therapies in ER+/HER2- Breast Cancer (NCT05101564) | Clinical Trial Compass
CompletedPhase 2
Umbrella Trial of Subtype-Targeted Therapies in ER+/HER2- Breast Cancer
United States19 participantsStarted 2023-03-20
Plain-language summary
The purpose of this study is to learn if adding a new drug that is targeted at a specific genetic change found in some breast tumors pre-operatively will slow the growth of the tumor more than standard anti-hormone therapy used to treat this type of breast cancer. Different therapies are being tested based on the specific gene changes in the tumor. Not every tumor will have a gene change that is being studied.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Pre-Screening Phase
* Biopsy-proven ER-positive, HER2-negative breast cancer. ER-positivity and PR-positivity are defined as ≥1% cells staining positive by immunohistochemistry. HER2-negativity is defined by IHC or FISH, per ASCO-CAP 2018 guidelines. Breast tumor must be intact and tumor size must be ≥ 1 cm as measured by ultrasound, mammogram, MRI, or clinical exam. If tumor is locally recurrent, it must be in the breast (not skin, node, or chest wall recurrence). Ki67 may or may not have been done locally but if done locally, must be ≥ 5%. Any nodal status is allowed, as M0 or M1 disease.
* Women or men, age ≥ 18 years old.
* Performance status 0 to 1 (by Eastern Cooperative Oncology Group \[ECOG\] scale).
* Ability to understand and the willingness to sign a written informed consent document.
Treatment Phase
* Breast tumor classifies as relevant integrative subtype per tumor sequencing performed and analyzed by central laboratory.
* Breast tumor Ki67 score ≥ 10% as assessed by central laboratory.
* Each investigational agent specific inclusion criteria can be found in the agent-specific appendix
Exclusion Criteria:
* Pregnant woman, as confirmed by positive serum hCG test prior to initiating study treatment. Nursing (lactating) woman also not allowed.
* Prior breast cancer-directed therapy (surgery, radiation, chemotherapy, or endocrine therapy) is not allowed, with the exception of people with in-breast recurrences. People with in-breast recurre…
What they're measuring
1
Percentage Change in Ki67
Timeframe: Measured pre-treatment and after treatment 15 or 19 days, based on the duration specified for the assigned therapy