NCI Community Oncology Research Program - Protocol Summary
SWOG S1501 - "Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase III"
The summary below serves as a brief review of the treatment plan and eligibility for the protocol.
This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
Please contact NCORP-KC for complete protocol information.
Cancer Control Clinical Trial
CANCER TYPE: Breast
RESEARCH BASE: SWOG
NCT NUMBER: NCT03418961
HIPPA FORM: DOWNLOAD HIPPA FORM
Consent Form: VIEW CONSENT FORM
Stage IV breast ca, at increased risk for cardiotoxicity, starting or currently taking trastuzumab based HER-2 targeted therapy, carvedilol vs. observation. DCP-001 Eligible
The tasks below must be completed in order to be considered a “validated ECHO lab” for S1501. Institutions participating in S1501 must use an ECHO lab that has been validated through the process described below.
1. S1501 ECHO Core Lab will create case report forms for S1501 and WebEx for obtaining ECHO Views and explanation of trial with drug distribution.
2. AGMedNet will work with S1501 ECHO Core Lab to set up transmission of ECHO (download software).
3. A data coordinator from the S1501 ECHO Core Lab will work with AGMedNet to install software at site to transmit ECHO and Case Report Forms.
4. Site will choose 2 breast cancer patients and perform ECHO. Site will deidentify ECHO and transmit via AGMedNet to S1501 ECHO Core Lab within 24 hours of acquisition.
5. S1501 ECHO Core Lab will analyze ECHOs and assess if adequate for Site Enrollment within 30 days of receipt. ECHOs will be reviewed by MD assigned to Core Lab for day.
6. ECHO ejection fraction will be reported to primary site investigator, primary oncologist, and SWOG.
Critical Findings Will Also Be Reported Such As:
-Hemodynamically significant cardiac tamponade
-Atrial or Ventricular Thrombus
-Severe valvular insufficiency or stenosis
7. If both ECHOs are adequate, site will be cleared for participation in S1501.
Treatment (Supplied Drug: Carvedilol 6.25mg; sites purchase drug and are reimbursed by SWOG)
Carvedilol 6.25mg, PO, BID, for 108 weeks
1 cycle = 12 weeks
Observation - these patients are already taking beta blocker, ARB, or ACE inhibitor at registration.
Eligibility Step 1 Registration
- Patients must have metastatic breast cancer and be initiating within 7 days of Step 1 Registration or continuing trastuzumab–based HER-2 targeted therapy without concurrent anthracyclines in first or second line setting. Patients may have brain metastasis. There is no limit for number of doses of HER-2 targeted therapy prior to registration. Examples of eligible HER-2 targeted therapy:
- Trastuzumab + chemotherapy or hormonal therapy
- Trastuzumab + other HER-2 targeted agent with or without chemotherapy (such as pertuzumab)
- Ado-trastuzumab (Kadcyla®)
- 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)
- Diabetes Mellitus
- Atrial fibrillation/flutter
- 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 order to be randomized (Arms 1 and 2). Patients currently taking a beta blocker, ARB, or ACE inhibitor at the time of Step 1 Registration are eligible to register for the non-randomized observational cohort (Arm 3).
- Patients must not be currently taking or planning to take during study treatment the following medications:
- B2 agonists
- Patients must have a Zubrod Performance Status of 0-2.
- Patients must be ≥ 18 years of age.
- Patients must have a complete physical examination and medical history within 28 days prior to registration.
- Patients must have LVEF ≥ 50% by 2-D echocardiogram within 28 days prior to registration. The echocardiogram must be obtained from a S1501 validated ECHO lab (see list of site “Validated ECHO Labs” on the S1501 protocol abstract page at www.swog.org) and submitted for central review by the S1501 ECHO Core Lab (see Section 15.2). ECHO should not be submitted for central read until patient has been otherwise deemed eligible.
- 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), SGOT/AST and SGPT/ALT < 5.0 x IULN.
- Patients must have electrocardiogram with QTc with correction within 28 days prior to registration.
- Patients must have a systolic blood pressure ≥ 80 mm Hg within 14 days prior to registration.
- Patients must not be dialysis dependent.
- Patients must be able to swallow tablets.
- Patients must not have uncontrolled asthma.
- Patients must not co-enroll on other treatment trials.
- 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 II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years.
- 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.
- Patients must be willing to submit blood specimens
Eligibility Step 2 Randomization
- Patients must not be registered to Step 2 until receiving confirmation from the ECHO Core Lab that the patient’s LVEF by echocardiogram was ≥ 50% by central review. Patients must be registered within 5 calendar days of receiving the e-mail notification.
- Site must verify that there is no known change in the Step 1 eligibility since initial registration.