Functional Precision Oncology for Metastatic Breast Cancer

  • End date
    Aug 19, 2025
  • participants needed
  • sponsor
    University of Utah
Updated on 19 April 2021


This is a pilot study to assess the feasibility of comprehensive genomic characterization and drug screening in metastatic breast cancer. The trial will seek to provide personalized genomic and drug sensitivity information to eligible patients with metastatic breast cancer prior to disease progression on standard treatment. The trial will also explore how these results influence physician selection of next-line therapy.


The study will enroll patients with Her2 negative (negative on immunohistochemistry or nonamplified by immunofluorescence in situ hybridization) metastatic breast cancer. Cohorts will enroll according to patient hormone receptor status as hormone receptor-positive or triple-negative. In Part 2, the trial will enroll six patients with triple-negative breast cancer and six patients with ER and/or PR receptor-positive breast cancer. Patients diagnosed with metastatic disease upfront or after a variable interval from completion of definitive therapy for local or locally advanced breast cancer will be eligible.

Patients with triple-negative metastatic breast cancer will be offered to participate in the trial at the time of diagnosis. Patients with hormone receptor-positive disease will be offered the option to participate in the study when they have exhausted endocrine monotherapy or endocrine therapeutic combinatorial options. Blood will be collected, and a biopsy will be performed prior to starting the first systemic therapy (triple-negative) or first chemotherapy (hormone receptor-positive). If enough tumor is collected, the patient will be deemed eligible for the trial. Malignant tissue collected from this biopsy will be used for genomic sequencing and for the development of organoid models for drug screening. Drugs selected for sensitivity testing will be guided by the results of the genome analysis and NCCN guidelines. Following tissue acquisition, the patient will begin therapy as selected by the treating physician. This first-line of on study therapy, either standard-of-care or investigational in the context of another existing active clinical trial, will be defined as the first "uninformed" line of therapy.

The results from the drug screening and mutation testing will be summarized and returned to the treating physicianbefore the assignment of on study, second-line therapy. Before and after returning results, the treating physician will be administered a survey to assess the potential effect that the precision medicine results have on the selection of the following line of therapy. If a patient begins a therapy that was recommended by the precision medicine results, the therapy will be defined as the "informed" line of therapy.

Patient response will be tracked for up to two uninformed lines of therapy. The first line of therapy started after the biopsy will count as the first uniformed line. If a patient does not begin an informed line of therapy after two lines of uninformed therapy they will be taken off study. Response and time of progression will be recorded on both informed and uninformed lines of therapy.

The trial will open to enrollment in two stages. Stage One will enroll three patients to assess preliminary program feasibility and to optimize the genomics pipeline and time frames. After enrollment of the first three patients, enrollment will be put on hold. Upon return of results to the treating physicians, the genomics pipeline and time frames will be evaluated. If necessary, the process will be amended to maximize pipeline efficiency and decrease the interval of time between tumor tissue acquisition and the return of results.

Stage Two will enroll 12 additional patients to further evaluate on a larger scale our functional precision oncology program in metastatic breast cancer.

Condition HER2 Negative Breast Cancer
Treatment Precision Medicine, Precision Medicine, Physican Decision Making
Clinical Study IdentifierNCT04450706
SponsorUniversity of Utah
Last Modified on19 April 2021


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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have HER2 Negative Breast Cancer??
Male or female subject aged 18 years
Her2 negative on immunohistochemistry or nonamplified breast cancer
Metastatic or recurrent unresectable breast cancer
Triple-negative breast cancer without prior treatment in the metastatic setting
Hormone receptor-positive breast cancer that has exhausted or refused all endocrine monotherapy or endocrine therapeutic combinatorial options
Willing and capable (per treating investigator's assessment) to undergo a baseline biopsy
Patient can safely undergo tumor biopsy
The tumor is reasonably accessible to biopsy
The tumor is amenable to biopsy, e.g. does not abut neurovascular structures
If the patient receives anticoagulation, anticoagulation can be safely withheld to accommodate for tissue acquisition
The patient does not have a medical condition that would render a tumor tissue acquisition a high-risk procedure, e.g. tumor tissue acquisition from lung metastases in a patient with emphysema
Successful acquisition of a tissue sample containing 20% tumor content
Life expectancy of 6 months as assessed by the treating investigator
ECOG Performance Status 2
Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply
Women < 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)
Women 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)
Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines
At least one lesion (measurable or non-measurable) that can be accurately assessed at baseline and is suitable for repeated assessment by computed tomography (CT), magnetic resonance imaging (MRI), plain X-ray, or physical examination

Exclusion Criteria

Diagnosis of any other malignancy within 2 years prior to study enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder or of the cervix on surveillance with no plans for treatment intervention (eg, surgery, radiation, or castration) or radiotherapy and currently with no evidence of disease or symptoms is allowed
The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions
Myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (> New York Heart Association Classification Class IIB) or a serious cardiac arrhythmia requiring medication
Renal or liver disease that prohibits the patient from receiving at least single-agent full recommended dose chemotherapy
The patient cannot safely undergo biopsy for reasons including but not limited to
Tumor is inaccessible
The patient requires anticoagulation which cannot be withheld
The patient has bleeding diathesis
Any other reason that would render tumor tissue acquisition a high-risk procedure
Patient cannot or is unwilling to receive chemotherapy
Patients with either history of or active spinal cord compression and/or brain metastases
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