Phase
Condition
Heart Failure
Breast Cancer
Circulation Disorders
Treatment
Biomarker Guided Intervention
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provision of written informed consent and HIPAA authorization
Stated willingness to comply with all study procedures and availability for theduration of the study
Male or female, ≥ 18 years of age
Diagnosed with breast cancer or lymphoma (any subtype), planned to receive ananthracycline based chemotherapy regimen. Patients may be enrolled up to their firstdose of anthracycline even if they have already received other chemotherapeutic ortargeted agents as part of neo-adjuvant or adjuvant systemic therapy.
Exclusion
Exclusion Criteria:
Diagnosed with Stage IV breast cancer
Uncontrolled blood pressure defined by SBP > 180mmHg on two or more occasions andtaking three or more antihypertensives within 1 month prior to enrollment.
Baseline systolic blood pressure < 90mmHg within 1 month prior to enrollment (ifmultiple blood pressures are available in the medical record within 1 month prior toenrollment, the average SBP will be considered)
Women must not be pregnant or breast-feeding due to the potential harm to an unbornfetus and possible risk for adverse events in nursing infants with someanti-hypertensives, including angiotensin receptor blockers. All females ofchildbearing potential must have a blood test or urine study within 10 days prior toenrollment to rule out pregnancy. All females of childbearing potential must bestrongly advised to use accepted and effective methods of contraception or toabstain from sexual intercourse for the duration of their participation in thestudy. A female of childbearing potential is defined as any woman, regardless ofsexual orientation or whether they have undergone tubal ligation, who meets thefollowing criteria: 1) has achieved menarche at some point, 2) has not undergone ahysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) forat least 24 consecutive months (i.e., has had menses at any time in the preceding 24consecutive months).
Patient with prior or concurrent malignancy whose natural history of treatment, inthe opinion of the investigator, has the potential to interfere with the safety orefficacy assessment of the investigational regimen
Patient must not have any of the following
Severe hepatic impairment, defined as serum bilirubin > ULN, or AST or ALT > 5.0 ULNon most recent labs prior to enrollment. Results of serum bilirubin, AST, and ALTmust be checked for screening if no results available in the EMR within 28 daysprior to enrollment.
end-stage renal failure on dialysis
hyperkalemia with a potassium > 5.5 mEq/l on most recent labs prior to enrollment.Serum potassium must be checked for screening if no results available in the EMRwithin 28 days prior to enrollment.
a history of kidney transplant
an eGFR < 30 ml/min/1.73m2 at most recent check prior to enrollment. Creatinine mustbe checked for screening if no results available in the EMR within 28 days prior toenrollment
cardiogenic shock
decompensated heart failure requiring the use of IV inotropic therapy
Non-English speaking
Study Design
Study Description
Connect with a study center
City of Hope
Duarte, California 91010
United StatesSite Not Available
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Chester County Hospital
West Chester, Pennsylvania 19380
United StatesSite Not Available
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