Cancer Vaccine + Chemotherapy for Breast Cancer

Overseen By Research Coordinator(s)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Washington

Must be taking: Chemotherapy

Must not be taking: Chronic steroids

Disqualifiers: PD-L1-positive, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 7 months

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase II trial studies how well a cancer vaccine called STEMVAC works in combination with chemotherapy in treating patients with PD-L1 negative, triple-negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). STEMVAC is designed to target proteins that are expressed on breast cancer stem cells, and it is believed to work by boosting the immune system to recognize and destroy the invader tumor cells that are causing the disease. The allowable combination chemotherapy includes: (1) Paclitaxel is in a class of chemotherapy medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. (2) Docetaxel is in a class of chemotherapy medications called taxanes. It stops tumor cells from growing and dividing and may kill them. (3) Cisplatin is in a class of chemotherapy medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. (4) Carboplatin is in a class of chemotherapy medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. (5) Doxorubicin is in a class of chemotherapy medications called anthracyclines. Doxorubicin damages the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. (6) Liposomal doxorubicin is a form of the anticancer drug doxorubicin that is contained inside very tiny, fat-like particles. Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. (7) Eribulin is in a class of chemotherapy medications called microtubule dynamics inhibitors. It works by stopping the growth and spread of tumor cells. Giving STEMVAC in combination with chemotherapy may be an effective treatment for PD-L1 negative metastatic triple-negative breast cancer.

Who Is on the Research Team?

Mary Disis, MD

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for patients with PD-L1 negative, metastatic triple-negative breast cancer. Participants must not have received certain treatments before and should be healthy enough to handle the vaccine and chemotherapy.

Inclusion Criteria

Meet specific hematologic and biochemical criteria

I can take care of myself and am up and about more than half of the day.

My breast cancer is confirmed triple-negative.

Exclusion Criteria

Known hypersensitivity reaction to the granulocyte-macrophage colony stimulating factor (GM-CSF) adjuvant

Pregnant and breastfeeding individuals

Enrollment in a concurrent interventional clinical trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive chemotherapy and STEMVAC vaccine. Chemotherapy regimens vary, and STEMVAC is administered with sargramostim intradermally every 21-28 days, with booster doses at 4 and 7 months after the 3rd priming dose.

7 months

Multiple visits (in-person) for chemotherapy and vaccine administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits every 6 months for 3 years.

3 years

Follow-up visits every 6 months

Research Biopsy

Participants may undergo CT or ultrasound-guided biopsy for research purposes during the study.

What Are the Treatments Tested in This Trial?

Interventions

• Eribulin
• STEMVAC

Trial Overview The effectiveness of STEMVAC, a cancer vaccine targeting proteins on breast cancer stem cells, is being tested in combination with various chemotherapy drugs like Paclitaxel, Docetaxel, Cisplatin, Carboplatin, Doxorubicin (including liposomal), and Eribulin.

How Is the Trial Designed?

Group I: Treatment (chemotherapy, STEMVAC, GM-CSF) Experimental Treatment 14 Interventions

See Detailed Description.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Kuni Foundation

Collaborator

Trials

3

Recruited

270+