Breast Cancer Clinical Trial

Umbrella Trial Testing Integrative Subtype-Targeted Therapeutics in HR+ /HER2-Negative Breast Cancer

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.

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Full Description

Primary Objective: To evaluate the efficacy of investigational agent compared with standard endocrine therapy in in reducing Ki67 values based on digital pathology (QuPath) from baseline to on-treatment biopsy after an specific treatment duration (i.e. 14 or 18 days) in ER-positive, HER2-negative tumors (tumor size ≥1 cm) with Ki67 ≥ 10%, for different integrative subtype categories identified at integrative subtype screening.

Secondary Objective: To evaluate the efficacy of investigational agent compared with standard endocrine therapy on the proportion of subjects with Ki67 < 10% after a specific treatment duration (i.e. 14 or 18 days)

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Eligibility Criteria

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.
Able to swallow and retain oral medication.
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 recurrences cannot have had breast cancer-directed therapy (radiation, chemotherapy, or endocrine therapy; surgery is acceptable) within the 6 months prior to signing the pre-screening consent. Pre-endocrine therapy for breast cancer risk reduction is allowed.
Known hypersensitivity to study agent (IP) or standard endocrine therapy drug, or to any of the excipients of study agent (IP) or standard endocrine therapy drug.
Impairment of gastrointestinal function or gastrointestinal disease that may significant alter the absorption of the study drugs (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) based on investigator discretion
Each study agent specific exclusion criteria can be found in the agent-specific appendix

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

264

Study ID:

NCT05101564

Recruitment Status:

Not yet recruiting

Sponsor:

Stanford University

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There is 1 Location for this study

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Stanford University
Stanford California, 94304, United States More Info
Allison Zhang
Contact
George Sledge, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

264

Study ID:

NCT05101564

Recruitment Status:

Not yet recruiting

Sponsor:


Stanford University

How clear is this clinincal trial information?

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