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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a cancer vaccine called STEMVAC when combined with chemotherapy to treat PD-L1 negative, triple-negative breast cancer that has metastasized. The goal is to determine if this combination can enhance the immune system's ability to recognize and destroy cancer cells. Chemotherapy options in the trial include paclitaxel, docetaxel, cisplatin, carboplatin, doxorubicin, eribulin, and others, which are known to stop or slow cancer cell growth. This trial may suit those with triple-negative breast cancer that is PD-L1 negative, has spread from the original site, and have not received prior cancer immunotherapy for metastatic cancer. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires a minimum of 14 days without any systemic therapy or palliative radiotherapy before starting the study treatment. However, treatment with bisphosphonates or denosumab is allowed during the study. It's best to discuss your specific medications with the study team to see if any adjustments are needed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that STEMVAC, a cancer vaccine, is being tested for safety and effectiveness. Early results from various studies suggest that combining STEMVAC with chemotherapy might be a promising treatment for breast cancer. However, researchers are still gathering more information about STEMVAC's safety.

Research has found the chemotherapy drug eribulin to be safe for use. While patients experience some side effects, they are usually manageable. Eribulin is already approved for treating advanced breast cancer, indicating its safety for this condition.

Overall, both STEMVAC and eribulin show potential in treating breast cancer, but ongoing research is crucial to confirm their safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about STEMVAC for breast cancer because it introduces a unique approach by combining a cancer vaccine with chemotherapy. Unlike traditional treatments that primarily target cancer cells directly, STEMVAC stimulates the body's immune system to recognize and attack cancer cells, potentially enhancing the overall effectiveness of chemotherapy. This dual strategy not only aims to treat existing tumors but also to prevent recurrence by training the immune system to remain vigilant against cancer cells in the future. This innovative combination offers hope for more durable responses and fewer side effects compared to standard chemotherapy alone.

What evidence suggests that this trial's treatments could be effective for metastatic triple-negative breast cancer?

Research has shown that STEMVAC, a cancer vaccine, might help treat PD-L1 negative metastatic triple-negative breast cancer. It boosts the immune system to find and destroy cancer cells. Early results suggest that combining STEMVAC with chemotherapy could enhance its effectiveness. In this trial, participants will receive a combination of STEMVAC, chemotherapy, and GM-CSF. Past studies have shown that one chemotherapy option, eribulin, helped patients with metastatic breast cancer live longer and reduced or eliminated tumors in about 60% of patients. Together, these treatments offer hope for better outcomes in this challenging form of breast cancer. ^{6 7 8 9 10}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4243003/

Efficacy of eribulin in women with metastatic breast cancer In Study 305/EMBRACE, eribulin was associated with improved overall survival (OS) compared with treatment of physician's choice (TPC) in patients who had ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.e13053

Survival outcomes in patients with metastatic breast cancer ... In 57 evaluable patients, the best objective response rate (ORR) was 43.85 percent, while the clinical benefit rate was 59.65 percent with ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1877782125000608

Eribulin efficacy in long responder patients with metastatic ... The median duration of response was 25 weeks. Results suggest that eribulin could be recommended as 2nd line of treatment in MBC patients.

4. annalsofoncology.org annalsofoncology.org/article/S0923-7534(20)40414-4/fulltext

316P Real-world treatment patterns and clinical ... A greater proportion of patients with TNBC were treated with eribulin in 3rd line (93%) compared with the overall patient cohort (80%), with the remainder ...

5. dovepress.com dovepress.com/early-real-world-treatment-patterns-and-clinical-outcomes-in-patients--peer-reviewed-fulltext-article-BCTT

Outcomes in Patients with MBC Treated With Eribulin | BCTT We assessed the treatment patterns and clinical outcomes in MBC patients treated with eribulin following treatment with an IO or ADC in US clinical practice.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11212747/

Eribulin in breast cancer: Current insights and therapeutic ... In terms of safety, eribulin has demonstrated an acceptable level of toxicity in the treatment of patients with breast cancer. Safety data from ...

7. halaven.com halaven.com/hcp/metastatic-breast-cancer/real-world-evidence

Exploratory Analysis Patient Subgroups HALAVEN (eribulin mesylate) Injection is indicated for the treatment of patients with metastatic breast cancer (mBC) who have previously received at least 2 ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2059702920324534

Eribulin for metastatic breast cancer (MBC) treatment Eribulin was shown to be an effective and safe therapeutic option in heavily pretreated patients with aBC.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04683445

Efficacy and Safety of Eribulin in the Treatment ... Compared with single drug chemotherapy, it can improve the overall survival time of 2.5 months, increase the clinical benefit rate by 5 times, and the tolerance ...

10. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e13002

Survival and safety analysis of eribulin in Indian patients ... Conclusions: This study confirms that Eribulin is effective and has manageable toxicity in patients with MBC. It should be considered as the ...