Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434064
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-23
Brief Title:
Tamoxifen and Pegylated Liposomal Doxorubicin for the Treatment of Patients With Metastatic or Inoperable Locally Advanced Triple Negative Breast Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A Pilot Single-Arm Phase II Trial of Tamoxifen Plus Pegylated Liposomal Doxorubicin in Patients With Metastatic Triple Negative Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial tests how well tamoxifen and pegylated liposomal doxorubicin works in treating patients with triple negative breast cancer that has spread from where it first started primary site to other places in the body metastatic or that has spread to nearby tissue or lymph nodes locally advanced and is unable to be operated on inoperable Tamoxifen works by blocking the effects of estrogen in the breast This may help stop the growth of tumor cells that need estrogen to grow Doxorubicin is in a class of medications called anthracyclines Doxorubicin damages the cells DNA and may kill cancer cells It also blocks a certain enzyme needed for cell division and DNA repair Liposomal doxorubicin is a form of the anticancer drug doxorubicin that is contained inside very tiny fat-like particles Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug Giving tamoxifen and pegylated liposomal doxorubicin together may work better in treating patients with metastatic or inoperable locally advanced triple negative breast cancer than giving either of these drugs alone
Detailed Description:
PRIMARY OBJECTIVE
I To determine the efficacy of the combination of tamoxifen and pegylated liposomal doxorubicin in patients with metastatic or inoperable locally advanced triple negative breast cancer TNBC estrogen receptor ER 10 as assessed by overall response rate ORR as defined by Response Evaluation Criteria in Solid Tumors RECIST version v 11
SECONDARY OBJECTIVES
I To assess the safety and tolerability of pegylated liposomal doxorubicin given in combination with tamoxifen
II To determine clinical benefit including overall and progression free survival overall survival OS and progression free survival PFS as defined by RECIST v11
III To determine the duration of response
EXPLORATORY OBJECTIVES
I To analyze changes in circulating tumor deoxyribonucleic acid ctDNA from longitudinal liquid biopsy to follow therapeutic response
II To determine estrogen receptor beta ERĪ²-mutant p53 interaction in tumors with in situ proximity ligation assay PLA
III To analyze changes in gene expression by global ribonucleic acid RNA-sequencing seq
IV To determine changes in the tumor microenvironment TME of tumors in response to treatment by analyzing tumor infiltrating lymphocytes TILS selected markers in the tumor and stromal tissues combined with CYBERSORT analysis of the transcriptome data
V Analyze changes in immune cell populations and circulating protein biomarkers as detectable from blood
OUTLINE
Patients receive tamoxifen orally PO once daily QD on days 1-28 of each cycle and pegylated liposomal doxorubicin intravenously IV on day 1 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients undergo echocardiography computed tomography CT scan or magnetic resonance imaging MRI tumor biopsy and blood sample collection throughout the study
After completion of study treatment patients are followed up at 30 days and every 6 months for up to 2 years
I To determine the efficacy of the combination of tamoxifen and pegylated liposomal doxorubicin in patients with metastatic or inoperable locally advanced triple negative breast cancer TNBC estrogen receptor ER 10 as assessed by overall response rate ORR as defined by Response Evaluation Criteria in Solid Tumors RECIST version v 11
SECONDARY OBJECTIVES
I To assess the safety and tolerability of pegylated liposomal doxorubicin given in combination with tamoxifen
II To determine clinical benefit including overall and progression free survival overall survival OS and progression free survival PFS as defined by RECIST v11
III To determine the duration of response
EXPLORATORY OBJECTIVES
I To analyze changes in circulating tumor deoxyribonucleic acid ctDNA from longitudinal liquid biopsy to follow therapeutic response
II To determine estrogen receptor beta ERĪ²-mutant p53 interaction in tumors with in situ proximity ligation assay PLA
III To analyze changes in gene expression by global ribonucleic acid RNA-sequencing seq
IV To determine changes in the tumor microenvironment TME of tumors in response to treatment by analyzing tumor infiltrating lymphocytes TILS selected markers in the tumor and stromal tissues combined with CYBERSORT analysis of the transcriptome data
V Analyze changes in immune cell populations and circulating protein biomarkers as detectable from blood
OUTLINE
Patients receive tamoxifen orally PO once daily QD on days 1-28 of each cycle and pegylated liposomal doxorubicin intravenously IV on day 1 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients undergo echocardiography computed tomography CT scan or magnetic resonance imaging MRI tumor biopsy and blood sample collection throughout the study
After completion of study treatment patients are followed up at 30 days and every 6 months for up to 2 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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| I-3671523 | OTHER | Roswell Park Cancer Institute | None |
| NCI-2024-03909 | REGISTRY | None | None |