Breast Cancer
Conditions
Brief summary
The purpose of this study is to create models out of tissue samples and treat those models with the same immunotherapy treatment the patient will be receiving, in order to validate this process and to predict responses to therapies and use it to choose the best treatments for people in the future. The researchers will then examine the direct effects of the treatment on those models.
Interventions
DRUGImmunotherapy
Organoid samples will be collected at time of biopsy and cultured in the lab. The samples will then receive the same standard of care immunotherapy treatment as the patient.
Sponsors
Indiana University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥ 18 years old at the time of informed consent 2. Ability to provide written informed consent and HIPAA authorization 3. Biopsy proven diagnosis of cancer 4. Able to obtain at least 2 16 gage cores of fresh tissue safely (3 or more cores preferred) 5. Planning to undergo standard of care Immunotherapy 6. Baseline standard of care CT within 8 weeks of starting Immunotherapy
Exclusion criteria
1. Inability to provide fresh biopsy sample 2. Any active infections 3. Any conditions that in the opinion of treating physician and the study team will compromise the ability of the patient to receive prescribed treatment to assess the response.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Calculate overall patient response rate | Baseline to 12 months | Compare patient response using RECIST 1.1 criteria and immune-organoid response based on the following criteria: 1. Complete response \<50% of viable tumor cells 2. Response \>50%\<70% of viable tumor cells 3. Stable \>70%\<90% viable tumor cell left 4. Progressive \>90% of viable tumor cell left |
| Reliability of organoid development | Baseline to 2 months | calculate the percentage of biopsies with successful organoid development |
Countries
United States
Outcome results
None listed