All > Immunotherapy > Metastatic Breast Cancer

Trastuzumab for Stage IV Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Fred Hutch/University of Washington Cancer Consortium, Seattle, WAStage IV Breast Cancer+4 MoreTrastuzumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the effects of a new drug, alpha-TEA, when given with the existing drug trastuzumab, for the treatment of HER2+ breast cancer that has stopped responding to other treatments and has spread to other parts of the body.

Eligible Conditions
  • Stage IV Breast Cancer
  • HER2-positive Breast Cancer
  • Metastatic Breast Cancer
  • Refractory Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Paclitaxel
1
Trastuzumab
1
Tucatinib

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Up to 4 years

Year 4
Change in level of activated effector memory CD4+ and CD8+ T-cells at 4 escalating doses of alpha-TEA and concurrent trastuzumab
Modulation of circulating natural killer (NK) cells with concurrent alpha-TEA and trastuzumab therapy
Year 4
Change in the number of HER2 specific T cells at each dose level
Up to 4 years
Clinical response rate of alpha-TEA when combined with trastuzumab
Incidence of adverse events of 4 escalating doses of alpha-tocopheryloxyacetic acid (TEA) therapy when combined with trastuzumab

Trial Safety

Safety Progress

1 of 3

Similar Trials

2
Paclitaxel
2
Trastuzumab
1
Tucatinib

Side Effects for

Trastuzumab
59%Leukopenia
56%Neutropenia
34%Hypoaesthesia
31%Agranulocytosis
22%Alopecia
22%Asthenia
19%Pyrexia
16%Nail disorder
16%Oedema peripheral
16%Diarrhoea
16%Hypophagia
13%Alanine aminotransferase increased
13%Neurotoxicity
13%Cough
13%Vomting
9%Aspartate aminotransferase increased
9%Headache
9%Musculoskeletal pain
9%Chest discomfort
9%Rash
9%Pigmentation disorder
9%Nausea
9%Bone marrow failure
9%Anaemia
6%Transaminases increased
6%Insomnia
6%Nasopharyngitis
6%Paronychia
6%Flushing
6%Face oedema
6%Constipation
6%Mouth ulceration
6%Thrombocytopenia
3%Cataract
3%Infection
3%Upper respiratory tract infection
3%Completed suicide
This histogram enumerates side effects from a completed 2014 Phase 4 trial (NCT01301729) in the Trastuzumab ARM group. Side effects include: Leukopenia with 59%, Neutropenia with 56%, Hypoaesthesia with 34%, Agranulocytosis with 31%, Alopecia with 22%.

Trial Design

1 Treatment Group

Treatment (alpha-TEA, trastuzumab)
1 of 1

Experimental Treatment

24 Total Participants · 1 Treatment Group

Primary Treatment: Trastuzumab · No Placebo Group · Phase 1

Treatment (alpha-TEA, trastuzumab)Experimental Group · 2 Interventions: Trastuzumab, Alpha-tocopheryloxyacetic Acid · Intervention Types: Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 years

Who is running the clinical trial?

Veana TherapeuticsLead Sponsor
Veana Therapeutics, Inc.UNKNOWN
University of WashingtonOTHER
1,610 Previous Clinical Trials
1,573,053 Total Patients Enrolled
William Gwin, MDPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
William GwinPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
1 Previous Clinical Trials
16 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 16 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You can still participate in the study if you are taking bisphosphonates and/or endocrine therapy.
You may have taken Lapatinib before for metastatic treatment, but it is not necessary.
References

Frequently Asked Questions

What level of security can be expected when utilizing Trastuzumab for treatment?

"The safety of Trastuzumab was assessed as a 1 on our company's rating system due to the limited clinical data available for Phase 1 trials." - Anonymous Online Contributor

Unverified Answer

How many participants are enrolled in this experiment?

"Correct. According to the clinicaltrials.gov listing, this medical study was first posted on April 8th 2020 and is currently accepting participants. The trial requires 24 individuals from a single center for enrollment." - Anonymous Online Contributor

Unverified Answer

Are there remaining vacancies for potential participants in this clinical trial?

"The information residing on clinicaltrials.gov substantiates that this medical study is presently taking applicants, with the original post being dated April 8th 2020 and a recent update occurring June 17 2022." - Anonymous Online Contributor

Unverified Answer

Which maladies is Trastuzumab most commonly employed to combat?

"Trastuzumab is often utilized for the treatment of brca1 gene-related ailments. In addition, it can prove effective in helping patients cope with infection, inflammatory [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) (IBC), and general breast issues." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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