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Lack of enrollment to meet the primary and secondary study goals
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| Name | Class |
|---|---|
| City of Hope Medical Center | OTHER |
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There are several approved and guideline-recommended treatments for metastatic, estrogen receptor-positive breast cancer that has progressed on an aromatase inhibitor and a CDK4/6 inhibitor. Right now, doctors do not have a good way of choosing between these treatments. Scientists we work with have come up with ways to use the biology of the tumor to try to predict which treatment is best. This study is being done to test if those predictions are right and to learn more about these tumors to design better treatments in the future.
This is an open-label phase II study of systems biology guided therapy for breast cancer patients positive for Oestrogen receptor after Aromatase inhibitor and CDK inhibition.
Based on the SOLAR-1 trial, 25% of tumors would have PIK3CA mutation, so 25% of people would be treated with fulvestrant plus alpelisib with a median PFS in that group of 11 months and 75% of people would be treated with fulvestrant with a median PFS in that group of 6 months.(3) The weighted average of these medians is 7.25 months, but since the actual distributions of the progression free survivals are not available, we will use a conservative estimate of the expected median PFS of the historical control group (fulvestrant +/- alpelisib as second line unguided therapy) of 8 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized Cancer Treatment Based on Biopsy Results | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsy-Guided Therapy Selection | Drug | All enrolled participants will undergo a tumor biopsy, which will be analyzed for genomic and transcriptomic alterations using FoundationOne (DNA) and Fulgent (RNA). Based on the genomic findings, participants will receive one of the following therapy standard-of-care treatment options: PI3K inhibitor + anti-estrogen therapy ( alpelisib + fulvestrant) MTOR inhibitor + anti-estrogen therapy (everolimus + exemestane) Anti-estrogen therapy alone (fulvestrant monotherapy) Cytotoxic chemotherapy (capecitabine) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | No data displayed because Outcome Measure has zero total participants analyzed. | Baseline to 36 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Turn Around Time for Systems Biology Analysis | No data displayed because Outcome Measure has zero total participants analyzed. | Baseline to 36 Months |
| Response Rate to Systems Biology Guided Therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Cohen, MD | Inova Schar Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aromatase Inhibitor and CDK Inhibition | Drug determined by treating oncologist based on recommendation from systems biology analysis.: All patients will have a biopsy at the beginning of the trial. The biopsy will be sent for DNA sequencing through FoundationOne(clinical test) and RNA profiling at Fulgent(research test) for determination of activation of various oncogenic pathways and phenotypes. The results will be analyzed and a treatment recommendation will be made to the treating physician based on an algorithm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aromatase Inhibitor and CDK Inhibition | Drug determined by treating oncologist based on recommendation from systems biology analysis.: All patients will have a biopsy at the beginning of the trial. The biopsy will be sent for DNA sequencing through FoundationOne(clinical test) and RNA profiling at Fulgent(research test) for determination of activation of various oncogenic pathways and phenotypes. The results will be analyzed and a treatment recommendation will be made to the treating physician based on an algorithm. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival | No data displayed because Outcome Measure has zero total participants analyzed. | Two patients enrolled on the study and then withdrew early prior to treatment, therefore no data were collected before study termination. | Posted | Baseline to 36 Months |
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Baseline to 36 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aromatase Inhibitor and CDK Inhibition | Drug determined by treating oncologist based on recommendation from systems biology analysis.: All patients will have a biopsy at the beginning of the trial. The biopsy will be sent for DNA sequencing through FoundationOne(clinical test) and RNA profiling at Fulgent(research test) for determination of activation of various oncogenic pathways and phenotypes. The results will be analyzed and a treatment recommendation will be made to the treating physician based on an algorithm. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Cohen, MD | Inova Health System | 7035767279 | adam.cohen@inova.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 18, 2022 | Feb 28, 2025 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Open label, interventional
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No data displayed because Outcome Measure has zero total participants analyzed.
| Baseline to 36 Months |
| Progression Free Survival Base on Concordance With Recommended Treatment | No data displayed because Outcome Measure has zero total participants analyzed. | Baseline to 36 Months |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Turn Around Time for Systems Biology Analysis | No data displayed because Outcome Measure has zero total participants analyzed. | Two patients enrolled on the study and then withdrew early prior to treatment, therefore no data were collected before study termination. | Posted | Baseline to 36 Months |
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| Secondary | Response Rate to Systems Biology Guided Therapy | No data displayed because Outcome Measure has zero total participants analyzed. | Two patients enrolled on the study and then withdrew early prior to treatment, therefore no data were collected before study termination. | Posted | Baseline to 36 Months |
|
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| Secondary | Progression Free Survival Base on Concordance With Recommended Treatment | No data displayed because Outcome Measure has zero total participants analyzed. | Two patients enrolled on the study and then withdrew early prior to treatment, therefore no data were collected before study termination. | Posted | Baseline to 36 Months |
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| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
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| D017437 |
| Skin and Connective Tissue Diseases |