The Cardiotoxicity of Cancer Therapy (CCT) study is an ongoing, prospective, longitudinal cohort study of breast cancer participants at the Rena Rowan Breast Cancer Center at the University of Pennsylvania (Philadelphia, PA). This study was approved by the Institutional Review Board of the University of Pennsylvania and all participants provided informed consent.
The study protocol has been previously described.19 (link) Briefly, participants were eligible to be included if they were at least 18 years of age, diagnosed with breast cancer, and treated with doxorubicin and/or trastuzumab therapy. The only exclusion criterion was pregnancy; participants with an abnormal baseline LVEF were not excluded. Treatment regimens were determined by the treating oncologist and classified into 3 primary categories: 1) doxorubicin (240 mg/m2) with concurrent cyclophosphamide, followed by paclitaxel (Dox); 2) trastuzumab with docetaxel and either cyclophosphamide or carboplatin (Tras); and 3) doxorubicin (240 mg/m2) with concurrent cyclophosphamide, followed by trastuzumab and paclitaxel (Dox+Tras).
Detailed clinical data, verified via physician medical records, and the MD Anderson Symptom Inventory – Heart Failure (MDASI-HF) survey assessing HF symptoms on a scale of 0–10, were obtained at baseline and followup.20 (link) Echocardiograms were also performed at standardized time intervals according to the prescribed treatment regimen.19 (link) In the Dox group, echocardiography was performed at baseline, at completion of paclitaxel (approximately 4 months after initiation of chemotherapy), and annually. In the Tras group, echocardiography was performed at baseline, every 3 months during trastuzumab, and annually. In the Dox+Tras group, echocardiography was performed at baseline, after doxorubicin (approximately 2 months after initiation of chemotherapy), every 3 months during trastuzumab, and annually.
The current analyses were limited to those participants enrolled between August 2010 and August 2015 who had a baseline assessment of cardiac function and at least 1 followup echocardiogram, and include echocardiography data up to 3.2 years after initiation of therapy.
The study protocol has been previously described.19 (link) Briefly, participants were eligible to be included if they were at least 18 years of age, diagnosed with breast cancer, and treated with doxorubicin and/or trastuzumab therapy. The only exclusion criterion was pregnancy; participants with an abnormal baseline LVEF were not excluded. Treatment regimens were determined by the treating oncologist and classified into 3 primary categories: 1) doxorubicin (240 mg/m2) with concurrent cyclophosphamide, followed by paclitaxel (Dox); 2) trastuzumab with docetaxel and either cyclophosphamide or carboplatin (Tras); and 3) doxorubicin (240 mg/m2) with concurrent cyclophosphamide, followed by trastuzumab and paclitaxel (Dox+Tras).
Detailed clinical data, verified via physician medical records, and the MD Anderson Symptom Inventory – Heart Failure (MDASI-HF) survey assessing HF symptoms on a scale of 0–10, were obtained at baseline and followup.20 (link) Echocardiograms were also performed at standardized time intervals according to the prescribed treatment regimen.19 (link) In the Dox group, echocardiography was performed at baseline, at completion of paclitaxel (approximately 4 months after initiation of chemotherapy), and annually. In the Tras group, echocardiography was performed at baseline, every 3 months during trastuzumab, and annually. In the Dox+Tras group, echocardiography was performed at baseline, after doxorubicin (approximately 2 months after initiation of chemotherapy), every 3 months during trastuzumab, and annually.
The current analyses were limited to those participants enrolled between August 2010 and August 2015 who had a baseline assessment of cardiac function and at least 1 followup echocardiogram, and include echocardiography data up to 3.2 years after initiation of therapy.
