Cancer Vaccine for Breast Cancer
(Cornerstone001 Trial)

Recruiting in Palo Alto (17 mi)

+20 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Aston Sci. Inc.

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests a new cancer vaccine for patients with certain types of breast cancer that didn't fully respond to initial treatments. The vaccine aims to boost the immune system to better fight the remaining cancer cells.

Eligibility Criteria

This trial is for patients with a specific type of breast cancer that's HER2-low and hormone receptor-negative, who still have cancer after initial treatment. They should be in good health overall, not pregnant or breastfeeding, free from infections like HIV or hepatitis, and without autoimmune diseases.

Inclusion Criteria

My cancer was stage I, II, or III before surgery.

My cancer is HER2 low according to specific guidelines.

My cancer is not driven by estrogen or progesterone hormones.

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Exclusion Criteria

I am currently on immune suppression therapy or was on it within the last 4 weeks.

I do not have active infections like TB, hepatitis B, C, or HIV.

I haven't had cancer, except for non-dangerous skin cancer or localized cancer, in the last 5 years.

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Treatment Details

Interventions

AST-301(pNGVL3-hICD) (Cancer Vaccine)

Trial OverviewThe study tests a new cancer vaccine (AST-301) combined with standard therapy against a placebo plus standard therapy in breast cancer patients post-surgery. The vaccine is given three times every three weeks with an additional booster at six months.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: AST-301(pNGVL3-hICD)+ChemotherapyExperimental Treatment4 Interventions

* AST-301/rhuGM-CSF (q 3 weeks, 3 cycles) + Standard adjuvant therapy\* * A booster (AST-301/rhuGM-CSF) at 24 weeks post the third vaccination * Standard adjuvant therapy will be pembrolizumab or capecitabine (q 3 weeks)

Group II: Placebo + ChemotherapyActive Control4 Interventions

* Placebo/rhuGM-CSF (q 3 weeks, 3 cycles) + Standard adjuvant therapy\* * A booster (Placebo/rhuGM CSF) at 24 weeks post the third vaccination * Standard adjuvant therapy will be pembrolizumab or capecitabine (q 3 weeks)