Breast Cancer
Biomarkers of Early Relapse in Non-Metastatic Triple Negative Breast Cancer (SSCF2020)
This study identifies biomarkers through a blood-draw biopsy which indicates early relapse in high-risk non-metastatic triple negative breast cancer (TNBC) patients who will undergo chemotherapy treatment followed by surgery. The goal is to improve long-term disease control of TNBC post-chemotherapy. The liquid biopsy biomarkers will indicate which patients may be at a high risk of relapse and will help guide proper treatment intervention.
Patient Population
Patients with confirmed diagnosis of triple negative breast cancer. (estrogen, progesterone, HER2: negative)
Patients who will have chemotherapy followed by surgery and possible radiation and additional chemotherapy.
Patients must be willing to provide blood samples
No evidence of metastasis confirmed by scans prior to start of any chemotherapy
Patients cannot have had cancer within the past five years except basal or squamous cell carcinoma (skin cancer).
Number of Patients: 20
Study Objectives
The primary objective is to identify biomarkers of early relapse in high-risk non-metastatic TNBC patients who will undergo chemotherapy followed by surgery.
Treatment Information
After consenting, participants will complete registration on an online website called All4Cure.
Blood will be collected before the patient starts chemotherapy, 3-8 weeks after chemotherapy but before surgery. Approximately 3 weeks after surgery, and then every 3 months for 24 months.
Blood may also be taken at additional times. No more than 100 mls of blood will be collected in one month.
If participant’s cancer recurs during this time, they will only be followed for survival.
Participants and their doctor will learn results of molecular testing that will be done on any residual cancer after surgery. They will not learn results of blood.
At time of surgery, if no residual cancer is found, participant will be removed from the study.
On-Site Study Visits
Signing consent and enrollment visit
Regular oncology appointments with blood draws as scheduled
2. All4Cure: Triple Negative Breast Cancer
Genomic testing provides a “blue print” of tumor cells, identifying potential targets for therapy. The All4Cure study convenes experts across the country to discuss previously successful treatments for targets. Data is shared on an online technology platform which enables patients to better understand cancer and better inform treatment decisions by oncologists.
Study Objectives
All4Cure aims to accelerate learning about cancer by sharing medical information and research results from cancer patients with fellow cancer patients, oncologists, and scientists on the All4Cure website with the hope that together patients, clinicians and researchers can cure cancer faster.
Treatment Information
The core hypothesis tested by this study is that engaging researchers, clinicians and patients in an online knowledge sharing platform will enable patients to better understand cancer, better inform treatment decisions made by oncologists and accelerate cancer research. Leftover samples from patients with cancer (blood, bodily fluids and/or tissues collected for clinical purposes) will be obtained and sent for various types of analyses and results will be shared on the All4Cure website.
Patient Population
Females with triple negative breast cancer
Patients must be at least 18 years of age
Disease suitable for biopsy including bone disease or have tumor tissue available from a previous biopsy
Number of Patients: 5000
On-Site Study Visits
Screening period (typically 1 day) where consent is signed, blood drawn, enrollment procedures completed
Active study period: patients are seen by their oncologist for their standard of care appointments. No extra study visits are required
Long-term Follow-up
Patients may withdraw at any time. We plan to follow patients indefinitely or for as long as they agree to be in the study, depending on the availability of resources.
