Trastuzumab for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Breast Cancer+2 More
Trastuzumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the effectiveness of GDC-0084 in combination with trastuzumab as a possible treatment for HER2-Positive Breast Cancer.

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: 2 years

18 and 24 weeks
CBR
2 Years
To evaluate the correlation between inhibition of p-4EBP1 in resected brain tumor tissue and intracranial response in the corresponding patient-derived xenograft (PDX) models of BCBM
2 years
DOR
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Objective extra-CNS response rates
Overall Response Rate in the CNS
Overall Survival
Progression Free Survival

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Trastuzumab
59%Leukopenia
56%Neutropenia
34%Hypoaesthesia
31%Agranulocytosis
22%Alopecia
22%Asthenia
19%Pyrexia
16%Nail disorder
16%Hypophagia
16%Oedema peripheral
16%Diarrhoea
13%Cough
13%Vomting
13%Alanine aminotransferase increased
13%Neurotoxicity
9%Rash
9%Chest discomfort
9%Anaemia
9%Nausea
9%Bone marrow failure
9%Aspartate aminotransferase increased
9%Musculoskeletal pain
9%Headache
9%Pigmentation disorder
6%Transaminases increased
6%Paronychia
6%Flushing
6%Thrombocytopenia
6%Face oedema
6%Insomnia
6%Nasopharyngitis
6%Mouth ulceration
6%Constipation
3%Completed suicide
3%Cataract
3%Infection
3%Upper respiratory tract infection
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

2 Treatment Groups

Cohort B: a pre-surgical window cohort
1 of 2
Cohort A: single-arm, two stage, phase II cohort
1 of 2

Experimental Treatment

47 Total Participants · 2 Treatment Groups

Primary Treatment: Trastuzumab · No Placebo Group · Phase 2

Cohort B: a pre-surgical window cohortExperimental Group · 2 Interventions: GDC-0084, Trastuzumab · Intervention Types: Drug, Drug
Cohort A: single-arm, two stage, phase II cohortExperimental Group · 2 Interventions: GDC-0084, Trastuzumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GDC-0084
Not yet FDA approved
Trastuzumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Kazia Therapeutics LimitedIndustry Sponsor
9 Previous Clinical Trials
1,277 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,014 Previous Clinical Trials
394,297 Total Patients Enrolled
134 Trials studying Breast Cancer
22,009 Patients Enrolled for Breast Cancer
Jose P Leone, MDPrincipal InvestigatorDana-Farber Cancer Institute

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a new or progressive brain metastasis(es) with clinical indication for resection.
You have a left ventricular ejection fraction (LVEF) of 50% or more.
You have a performance status of ≤ 2.
You have at least one measurable CNS metastasis.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 25th, 2021

Last Reviewed: November 21st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.