Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00195091
Status:
TERMINATED
Last Update Posted:
2024-04-23
First Post:
2005-09-14
Brief Title:
Phase II Study of Tetrathiomolybdate TM in Patients With Breast Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Study of Tetrathiomolybdate TM in Patients With Breast Cancer at Moderate to High Risk of Recurrence
Status:
TERMINATED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left MSKCC
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with moderate to high risk primary breast cancer Stage II with more than 4 lymph nodes involved with cancer III or Stage IV without evidence of disease will take tetrathiomolybdate TM pills for two years
The objectives of the study are to
Assess the safety and tolerability of tetrathiomolybdate in patients with breast cancer at high risk of tumor recurrence
Observe the disease-free survival of patients in this trial
Conduct background scientific experiments on tumor tissue and blood of patients in this study
The objectives of the study are to
Assess the safety and tolerability of tetrathiomolybdate in patients with breast cancer at high risk of tumor recurrence
Observe the disease-free survival of patients in this trial
Conduct background scientific experiments on tumor tissue and blood of patients in this study
Detailed Description:
Patients with moderate to high risk primary breast cancer -Stage III Triple negative T 4 cm N0 any N Stage IV without evidence of disease will take tetrathiomolydbate TM pills for two years
Extension study 1 - If patients are shown to be copper depleted they are given the option to continue to receive TM for an additional 2 years
Extension study 2 - Open to patients who are stage 4 NED 10 involved lymph nodes or triple negative molecular subtype and candidates will continue for months 49-72
Extension study 3 - Open to patients who are stage 4 NED receiving a benefit from TM These subjects can continue receiving TM for 73-96 months
Extension study 4 - Open to patients who are stage 4 NED receiving a benefit from TM These subject can continue receiving TM for 97-120 months
Extension study 1 - If patients are shown to be copper depleted they are given the option to continue to receive TM for an additional 2 years
Extension study 2 - Open to patients who are stage 4 NED 10 involved lymph nodes or triple negative molecular subtype and candidates will continue for months 49-72
Extension study 3 - Open to patients who are stage 4 NED receiving a benefit from TM These subjects can continue receiving TM for 73-96 months
Extension study 4 - Open to patients who are stage 4 NED receiving a benefit from TM These subject can continue receiving TM for 97-120 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| 0309006307 | OTHER | Weill Cornell Medical College | None |