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Tests treatment safety and results 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?
Trastuzumab is an investigational medicine, being studied as a potential treatment for breast cancer.
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
- Trastuzumab is an important treatment for HER 2 positive breast cancer. But trastuzumab can cause injury to the heart, and this is one of the main reasons it cannot be administered as planned.
- 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's taking place
- Porto Alegre, Rio Grande do Sul, Brazil
- São Paulo, São Paulo, Brazil
- Hamitlon, Ontario, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- Novosibirsk, Russia
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 - 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?
Study sites include Porto Alegre, Rio Grande do Sul, Brazil; São Paulo, São Paulo, Brazil; Hamitlon, Ontario, Canada; Ottawa, Ontario, Canada; Toronto, Ontario, Canada; Novosibirsk, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.