Ignite Creation Date:
2024-05-06 @ 8:08 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02677714
Status:
TERMINATED
Last Update Posted:
2020-12-11
First Post:
2016-01-26
Brief Title:
99mTc-rhAnnexin V-128 Imaging and Cardiotoxicity in Patients With Early Breast Cancer
Sponsor:
Advanced Accelerator Applications
Organization:
Advanced Accelerator Applications
Study Overview
Official Title:
99mTc-rhAnnexin V-128 Imaging of Apoptosis and Cardiotoxicity in Relationship to Ventricular Function in Patients With Early Stage Breast Cancer Receiving Doxorubicin-Based Chemotherapy
Status:
TERMINATED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor Decision based on strategic considerations
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 neoadjuvant therapy to be followed by paclitaxel or docetaxel as per clinical practice The planned doxorubicin-based chemotherapy treatment consisted of doxorubicin 60 mgm2 in combination with cyclophosphamide 600 mgm2 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 Screeningbaseline ie 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
1 Screeningbaseline ie 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
Detailed Description:
Overall it was planned to recruit 30 adults with early stage breast cancer The first 10 patients were to be enrolled in the PoC phase of the study to assess the potential of 99mTc-rhAnnexin V-128 in terms of imaging quality uptake and medical relevance Based on the results of the first 10 patients the DMC was to decide whether to terminate the study or continue to the Phase II and enroll the next 20 planned patients The maximum study duration was 26 4 weeks per patient including the screening and follow-up periods
The sponsor decided to terminate the study earlier than planned due to strategic decisions to focus the AAA development portfolio on oncology theragnostics and not based on safety concerns
The sponsor decided to terminate the study earlier than planned due to strategic decisions to focus the AAA development portfolio on oncology theragnostics and not based on safety concerns
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CAAA113A42202 | OTHER | Novartis | None |