Trial studying safety and effects for Breast Cancer
Official title Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction
ClinicalTrials.gov ID: NCT04680442
What this study is testing
What is Trastuzumab?
an investigational monoclonal antibody being studied as a potential treatment for early stage HER‑2 positive breast cancer is designed to target HER‑2 receptors on cancer cells
Also referred to as Herceptin, Herzuma, Ogivri, Trazimera, Kanjinti.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether it is safe to keep using certain breast cancer drugs. It compares this to stopping the drugs when the heart is weak.
- Who it's for
- You may be able to join if you have early-stage breast cancer. Your heart must be working a bit less well than normal.
- What's involved
- You would keep taking your breast cancer medicine. The team will check your heart health often to see how it is doing.
- Time commitment
- The study lasts as long as you need the cancer treatment. You will need regular visits to check your heart.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Stage I-III HER-2 positive breast cancer
- Receiving adjuvant or neoadjuvant therapy with trastuzumab, pertuzumab, or trastuzumab-emtansine (T-DM1)
- Evidence of left ventricular dysfunction, as defined by at least one of: a) LVEF \< 54% or b) LVEF ≥54% and either i) fall in LVEF of ≥15% from prior...
You likely can't join if
- Current use of both angiotensin converting enzyme inhibitor (ACEI) /angiotensin receptor blocker (ARB) and beta-blocker
- Contra-indication to both ACE-I/ARB and beta-blockers
- NYHA class III or IV heart failure
- LVEF \<40%
- Systolic blood pressure \<100mmHg
- Current or planned pregnancy or breastfeeding
The study team makes the final eligibility decision.
Where it is enrolling
- Porto Alegre, Rio Grande do Sul, Brazil
- São Paulo, São Paulo, Brazil
- Hamitlon, Ontario, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Porto Alegre, Rio Grande do Sul, Brazil; São Paulo, São Paulo, Brazil; Hamitlon, Ontario, Canada; Ottawa, Ontario, Canada; Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.