What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as those involving immune response stimulation and standard adjuvant therapies like pembrolizumab or capecitabine, often have a range of side effects. Pembrolizumab, an immune checkpoint inhibitor, can cause fatigue, rash, diarrhea, and more severe immune-related adverse events like pneumonitis and colitis. Capecitabine, a chemotherapeutic agent, frequently leads to hand-foot syndrome, diarrhea, nausea, and fatigue. Additionally, therapeutic cancer vaccines like AST-301 may cause injection site reactions, flu-like symptoms, and other immune-related side effects. Overall, while these treatments can be effective, they come with a spectrum of potential adverse effects that should be managed under medical supervision.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer that target HER2-expressing cells. Notably, trastuzumab (Herceptin) was one of the first monoclonal antibodies approved for HER2-positive breast cancer. Pertuzumab (Perjeta) and ado-trastuzumab emtansine (Kadcyla) are other HER2-targeted therapies that have been approved. These treatments work by targeting the HER2 receptor, thereby inhibiting cancer cell growth and survival. Additionally, pembrolizumab (Keytruda), an immune checkpoint inhibitor, has been approved for certain types of breast cancer, including those with high PD-L1 expression. These therapies, like the AST-301 vaccine, aim to harness the immune system to combat cancer cells.

What other types of research exist?

Promising novel alternatives to AST-301 for breast cancer patients in 2024 include: 1) Trastuzumab deruxtecan (Enhertu), an antibody-drug conjugate targeting HER2 with significant efficacy in HER2-low and HER2-positive breast cancer. 2) Tucatinib, a HER2-targeted tyrosine kinase inhibitor, often used in combination with trastuzumab and capecitabine. 3) Margetuximab, an Fc-engineered anti-HER2 monoclonal antibody designed to enhance immune response. 4) Pembrolizumab, an immune checkpoint inhibitor, particularly in combination with chemotherapy for triple-negative breast cancer. These therapies represent advanced options with promising clinical outcomes.

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Cancer Vaccine for Breast Cancer (Cornerstone001 Trial)

Phase 2

Waitlist Available

Research Sponsored by Aston Sci. Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has stage I, II, or III disease prior to surgery per American Joint Committee on Cancer (AJCC)

HER 2 1+ by IHC or HER2 2+ by IHC without gene amplification by ISH, as defined by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines

Must not have

Has active infection including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection

Has a history of invasive malignancy ≤5 years prior to first administration of investigational drug except for adequately treated non-melanoma skin cancer or carcinoma in situ

Timeline

Screening 3 weeks

Treatment Varies

Follow Up overall study period approximately up to 4years (end of study in this study is defined as 2years frm the date of last patient in.

Summary

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.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Possible side effects may include reactions to the vaccine such as redness or pain at the injection site, flu-like symptoms, fatigue, and potential immune system responses due to activation by the vaccine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Select...

My cancer is HER2 low according to specific guidelines.

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My cancer is not driven by estrogen or progesterone hormones.

Select...

I still have cancer in my breast after initial treatment.

Select...

I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ overall study period approximately up to 4years (end of study in this study is defined as 2years frm the date of last patient in.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~overall study period approximately up to 4years (end of study in this study is defined as 2years frm the date of last patient in.

This trial's timeline: 3 weeks for screening, Varies for treatment, and overall study period approximately up to 4years (end of study in this study is defined as 2years frm the date of last patient in. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

2-year invasive disease free survival rate (iDFS)

Secondary study objectives

AST-301 specific T cell immune responses

Change in central memory T cell populations

Distant Recurrence-Free Survival rate, dRFS rate

+1 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + CRT Followed by Placebo

Pembrolizumab + CRT Followed by Pembrolizumab

Trial Design

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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

rhuGM-CSF

2014

Completed Phase 2

~70

Pembrolizumab

2017

Completed Phase 3

~3150

Capecitabine

2013

Completed Phase 3

~4280

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer, particularly those targeting HER2-expressing cells, include monoclonal antibodies like trastuzumab and pertuzumab, which bind to the HER2 receptor and inhibit cell proliferation. Additionally, therapeutic cancer vaccines like AST-301 aim to stimulate the immune system to recognize and attack HER2-positive cancer cells. These treatments are crucial for breast cancer patients as they offer targeted therapy, potentially reducing tumor growth and recurrence while minimizing damage to healthy cells. This targeted approach can lead to better outcomes and fewer side effects compared to traditional chemotherapy.

Therapeutic dendritic cell vaccination of patients with renal cell carcinoma.