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Shorter HER2-targeted Therapy for Breast Cancer

Phase 4
Recruiting
Led By Sharon McGee, MD
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Treated with neoadjuvant chemotherapy and HER2 targeted therapy preoperatively with a pathological complete response (pCR) defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy at surgery. Must have received less than 6 months of HER2 targeted therapy
Early-stage (I-III, i.e. non-metastatic) as per AJCC 8th edition, ER/PR positive or negative, HER2-positive as per 2018 American Society of Clinical Oncology/College of American Pathologists human epidermal growth factor receptor 2 (HER2) testing in breast cancer guidelines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years from study enrolment
Awards & highlights

Study Summary

This trial is testing whether 6 months of HER2 targeted therapy is just as effective as the current standard of 1 year for patients with early-stage, HER2 positive breast cancer who achieve a pathological complete response with upfront systemic chemotherapy and HER2 targeted therapy.

Who is the study for?
This trial is for people with early-stage HER2-positive breast cancer who've had a complete response to initial chemo and HER2 therapy. They should not have any remaining invasive cancer after pre-surgery treatment, be able to consent in English or French, and haven't yet received 6 months of HER2 therapy.Check my eligibility
What is being tested?
The study tests if 6 months of HER2-targeted therapy (Trastuzumab) is effective for patients who responded well to initial treatments. It's a single-arm, multicentre trial focused on those with non-metastatic breast cancer seeking less intensive post-surgery treatment.See study design
What are the potential side effects?
Trastuzumab can cause heart problems like heart failure and may require regular hospital visits for administration. The goal is to see if reduced treatment duration lowers these risks while maintaining effectiveness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had successful breast cancer treatment with no cancer found after surgery and took HER2 therapy for less than 6 months.
Select...
My breast cancer is in stages I-III and may be ER/PR positive or negative, but is HER2 positive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years from study enrolment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years from study enrolment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Enrolment of at least 50 participants across all sites within 9 months of the fourth site accruing its first participant
Medical oncologist active participation
Multiple site activation
Secondary outcome measures
Cardiac events
Disease free survival
Health-related quality of life
+3 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729
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%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: De-escalated HER2 targeted treatmentExperimental Treatment1 Intervention
Patients with early-stage HER2-positive breast cancer who demonstrate a pathological complete response at time of surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~5190

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
561 Previous Clinical Trials
2,785,444 Total Patients Enrolled
34 Trials studying Breast Cancer
5,211 Patients Enrolled for Breast Cancer
Sharon McGee, MDPrincipal InvestigatorOttawa Hospital Research Institute
3 Previous Clinical Trials
499 Total Patients Enrolled
2 Trials studying Breast Cancer
237 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Trastuzumab a viable treatment option with minimal risk to patients?

"The safety of Trastuzumab was assessed as a 3, since it is in Phase 4 trials and has received FDA approval."

Answered by AI

What is the scope of participants involved in this research endeavor?

"Yes, according to the information available on clinicaltrials.gov this study is actively recruiting for 50 participants from 1 medical centre. The trial was initially posted in December 2021 and has had its details updated as recently as April 2022."

Answered by AI

Is enrollment being opened for this examination?

"Affirmative, clinicaltrials.gov attests to this medical trial still recruiting participants after being initially uploaded on December 13th 2021 and updated as recently April 26th 2022. A total of 50 individuals need to be enrolled from a single research centre."

Answered by AI

What key findings is this experiment looking to bring forth?

"This multi-site clinical trial will span two years and the primary objective is to activate locations. Secondary goals include assessing health related quality of life using EQ-5D-5L, measuring incremental cost effectiveness ratios between 6 months versus 12 months HER2 therapy, and evaluating disease free survival at three year intervals."

Answered by AI

To what ailment is Trastuzumab most often prescribed?

"Trastuzumab is commonly used to treat breast cancer. It can also be employed in higher risk recurrence scenarios, as first line treatment, and after surgery."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluating 6-months of HER2-targeted Therapy in Patients With HER2 Positive Early-stage Breast Cancer That Achieve a Pathological Complete Response to Neoadjuvant Systemic Therapy
2021. "Evaluating 6-months of HER2-targeted Therapy in Patients With HER2 Positive Early-stage Breast Cancer That Achieve a Pathological Complete Response to Neoadjuvant Systemic Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04928261.
~18 spots leftby Sep 2025
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