99mTc-rhAnnexin V-128 Imaging and Cardiotoxicity in Patients With Early Breast Cancer (NCT02677714) | Clinical Trial Compass
TerminatedPhase 2
99mTc-rhAnnexin V-128 Imaging and Cardiotoxicity in Patients With Early Breast Cancer
Stopped: Sponsor Decision based on strategic considerations
Canada14 participantsStarted 2016-11-02
Plain-language summary
This was a single center, proof-of-concept (PoC), Phase II study. Patients with histologically confirmed early stage (Stage I, II or III) HER-2 negative breast cancer and scheduled to receive doxorubicin-based (neo)adjuvant therapy to be followed by paclitaxel or docetaxel as per clinical practice. The planned doxorubicin-based chemotherapy treatment consisted of doxorubicin 60 mg/m2 in combination with cyclophosphamide 600 mg/m2 (AC) intravenous (IV) every 2 or 3 weeks for 4 cycles. Patients were scheduled for CMRI and 99mTc-rhAnnexin V-128 imaging (planar and SPECT / CT) at the following visits:
1. Screening/baseline, i.e. 2 weeks prior to initiating AC treatment (Visit 1)
2. After the 2nd and before the 3rd cycle of AC treatment (Visit 2)
3. After the 4th cycle of AC treatment and within 2 weeks (Visit 3)
4. At 12 weeks after the 4th cycle of AC treatment (Visit 4). The imaging procedures were conducted and analyzed. Bloodwork for cardiotoxicity biomarkers (troponin, N terminal pro B-type natriuretic peptide \[NT-proBNP\]) was performed at each visit.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Females \>= 18 years of age with histologically confirmed early stage (Stage I, II or III) HER-2 negative breast cancer and planned for (neo)adjuvant doxorubicin-based chemotherapy (AC every 2 or 3 weeks x 4 cycles)
✓. Eastern Cooperative Oncology Group Status (ECOG) ≤ 2
✓. Able and willing to comply with the study procedures
Exclusion criteria
✕. Pregnancy or lactation
✕. Moderate or severe valvular stenosis or regurgitation
✕. History of atrial fibrillation or flutter
✕. History of any disease or relevant physical or psychiatric condition which may interfere with the study objectives at the investigator judgment
✕. Know hypersensitivity to the investigational product (IP) or any of its components
✕. Prosthetic valve or pacemaker
✕
What they're measuring
1
Part I / Proof of Concept (PoC): Number of Participants Evaluated for Imaging Feasibility