BridgeMD
New treatment option for Cardiotoxicity
Official title S1501 Dual Observational and Randomized Cohort Study of Patients With Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity
ClinicalTrials.gov ID: NCT03418961
What this study is testing
What is Carvedilol?
Carvedilol is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for cardiotoxicity.
Also referred to as Coreg.
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 trial has two cohorts of patients with human epidermal growth factor receptor (HER)-2-positive breast cancer that has spread to other places in the body. All patients must be receiving trastuzumab-based treatment.
- Phase 3: a large, late-stage study
- Time commitment: about 108 weeks
- 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
Ages 18 and older
You may be able to join if
- STEP 1 REGISTRATION Patients must:
- Have metastatic breast cancer, AND
- Be initiating within 11 calendar days of Step 1 Registration OR be continuing trastuzumab-based HER-2 targeted therapy without concurrent...
- Be receiving the trastuzumab-based HER-2 targeted therapy for metastatic disease in first, second, third-, or fourth-line setting. Patients may have...
- Trastuzumab or a trastuzumab biosimilar
See the full eligibility criteria
- STEP 1 REGISTRATION Patients must:
- Have metastatic breast cancer, AND
- Be initiating within 11 calendar days of Step 1 Registration OR be continuing trastuzumab-based HER-2 targeted therapy without concurrent anthracyclines, AND
- Be receiving the trastuzumab-based HER-2 targeted therapy for metastatic disease in first, second, third-, or fourth-line setting. Patients may have brain metastasis. There is no limit for number of doses of HER-2...
- Trastuzumab or a trastuzumab biosimilar
- Trastuzumab + chemotherapy or hormonal therapy
- Trastuzumab + other HER-2 targeted agent with or without chemotherapy (such as pertuzumab, lapatinib, and tucatinib)
- Ado-trastuzumab (Kadcyla®)
- Fam-trastuzumab deruxtecan (Enhertu) NOTE: Patients on lapatinib without trastuzumab are not eligible. Planned treatment with concurrent HER-2 targeted therapy and anthracyclines is not permitted.
- Patients must be at increased risk for cardiotoxicity defined by at least one of the following:
- Previous anthracycline exposure OR
- 1 or more of the following risk factors for heart disease:
- LVEF 50-54% by local ECHO read\
- Age ≥ 65
- BMI ≥ 30 kg/m2
- Current or prior anti-hypertensive therapy
- Diagnosis of coronary artery disease (CAD)
- Diagnosis of diabetes mellitus
- Diagnosis of atrial fibrillation/flutter Note: ECHO can be performed at any time prior to registration with the most recent being sent.
- Patients must not have taken within 21 days prior to Step 1 Registration, be currently taking at the time of Step 1 Registration or planning to take once registered to Step 1 a beta blocker, ARB, or ACE inhibitor, in...
- Patients must have a Zubrod Performance status of 0-2
- Patients must have a complete physical examination and medical history within 28 days prior to registration
- Patients must have LVEF \>= 50% echocardiogram (2D or 3D) within 28 days prior to registration. The echocardiogram must be obtained from a S1501 validated ECHO laboratory (lab) and submitted for central review by the...
- Patients must have adequate hepatic function as evidenced by all of the following within 28 days prior to registration:
- Serum bilirubin \< 3.0 x institutional upper limit of normal (IULN)
- Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) and serum glutamic pyruvic transaminase (SGPT)/alanine aminotransferase (ALT) \< 5.0 x IULN
- Patients must not be dialysis dependent
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, prostate cancer on active surveillance, adequately treated stage I or...
- Patients must not be pregnant or nursing due to potential fetal or nursing infant harm; women/men of reproductive potential must have agreed to use an effective contraceptive method, a woman is considered to be of...
- Patients must be willing to submit blood specimens
- Sites must seek additional patient consent for the future use of specimens
- Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
- For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and CIRB...
- As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been...
- STEP 2 REGISTRATION (Randomization)
- Patients must not be registered to step 2 until confirming via RAVE EDC that the patient's LVEF by echocardiogram was \>= 50% by central review. Patients must be registered within 21 calendar days of submission of the...
- Site must verify that there is no known change in the step 1 eligibility since initial registration
The study team makes the final eligibility decision.
Where it's taking place
- Anchorage, Alaska, United States
- Fairbanks, Alaska, United States
- Hot Springs, Arkansas, United States
- Antioch, California, United States
- Burbank, California, United States
- Chico, California, United States
- Duarte, California, United States
- Dublin, California, United States
- Emeryville, California, United States
- Fremont, California, United States
- Fresno, California, United States
- Los Angeles, California, United States
- Martinez, California, United States
- Mission Hills, California, United States
- Modesto, California, United States
- Newport Beach, California, United States
- Oakland, California, United States
- Rancho Cordova, California, United States
- Redwood City, California, United States
- Richmond, California, United States
+ 368 more site(s).
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 study runs about 108 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anchorage, Alaska, United States; Fairbanks, Alaska, United States; Hot Springs, Arkansas, United States; Antioch, California, United States; Burbank, California, United States; Chico, California, United States and 382 more location(s). 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.