Ignite Creation Date:
2024-05-06 @ 3:06 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04529044
Status:
UNKNOWN
Last Update Posted:
2022-07-11
First Post:
2020-08-24
Brief Title:
177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast Cancer
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
A Phase II Pilot Study of Lutetium 177Lu-DOTATATE in Patients With Metastatic Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial investigates how well 177Lu-DOTATATE works in treating patients with breast cancer that is stage IV or has come back recurrent 177Lu-DOTATATE may shrink or destroy the tumor or circulating breast cancer stem cells if they show evidence of the SSTR2 177Lu-DOTATATE is a targeted therapy that uses DOTATATE linked to a radioactive agent called 177Lu DOTATATE attaches to tumor cells with SSTR2 and delivers 177Lu to kill them Giving 177Lu-DOTATATE may help decrease the number and size of tumors and the number of circulating cancer stem cells in patients blood for the treatment of patients with breast cancer positive for SSTR2
Detailed Description:
PRIMARY OBJECTIVE
I Assess objective response in study participants receiving lutetium Lu 177 tetra-azacyclododecanetetra-acetic acid dota tyr3-octreotate tate 177Lu-DOTATATE therapy
SECONDARY OBJECTIVES
I Assess the rate of disease control following 177Lu-DOTATATE therapy II Evaluate duration of treatment response to 177Lu-DOTATATE III Assess progression-free survival PFS IV Assess safety and tolerability of the 177Lu-DOTATATE therapy V Evaluate over time the requirements for stable disease
EXPLORATORY OBJECTIVES
I Evaluate changes in the number of circulating SSTR2 breast cancer cells including cancer stem cell sub-populations following 177Lu-DOTATATE treatment
II Assess changes in gene profile among SSTR2 breast cancer cells following 177Lu-DOTATATE treatment
OUTLINE
Patients receive 177Lu-DOTATATE intravenously IV over 30-40 minutes during weeks 1 8 16 and 24 in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for up to 5 years
I Assess objective response in study participants receiving lutetium Lu 177 tetra-azacyclododecanetetra-acetic acid dota tyr3-octreotate tate 177Lu-DOTATATE therapy
SECONDARY OBJECTIVES
I Assess the rate of disease control following 177Lu-DOTATATE therapy II Evaluate duration of treatment response to 177Lu-DOTATATE III Assess progression-free survival PFS IV Assess safety and tolerability of the 177Lu-DOTATATE therapy V Evaluate over time the requirements for stable disease
EXPLORATORY OBJECTIVES
I Evaluate changes in the number of circulating SSTR2 breast cancer cells including cancer stem cell sub-populations following 177Lu-DOTATATE treatment
II Assess changes in gene profile among SSTR2 breast cancer cells following 177Lu-DOTATATE treatment
OUTLINE
Patients receive 177Lu-DOTATATE intravenously IV over 30-40 minutes during weeks 1 8 16 and 24 in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for up to 5 years
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 |
|---|---|---|---|
| STUDY00019489 | OTHER | OHSU Knight Cancer Institute | None |
| NCI-2020-04795 | REGISTRY | None | None |