Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525766
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Adaptive Therapy With Capecitabine for the Treatment of Metastatic Estrogen Receptor Positive HER2 Negative Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Single Arm Pilot Trial of Adaptive Therapy AT With Capecitabine for the Treatment of Metastatic Estrogen Receptor Positive Hormone Refractory Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
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 evaluates the effect of capecitabine on tumor response using imaging and tumor markers to adjust dose adaptive therapy in patients with estrogen receptor ER positive HER2 negative breast cancer that has spread from where it first started to other areas in the body metastatic Capecitabine is in a class of medications called antimetabolites It is taken up by tumor cells and breaks down into fluorouracil a substance that kills tumor cells Adaptive therapy with capecitabine based on tumor burden response may slow or stop the growth of tumor cells in patients with metastatic ER positive HER2 negative breast cancer
Detailed Description:
PRIMARY OBJECTIVE
I Evaluate the feasibility of adaptive therapy AT in hormone receptor positive metastatic breast cancer defined as the number of patients who can achieve AT modification for 2 or more cycles
SECONDARY OBJECTIVES
I To evaluate time to progression in patients receiving capecitabine AT defined as the interval between treatment start and tumor progression or death in patients with no evidence of disease progression
II Assess overall survival in patients receiving capecitabine as adaptive therapy
III Evaluate patient related outcomes by measuring quality of life and global health status of patients on AT using the European Organization for Research and Treatment of Cancer EORTC Quality of Life Core 30 questionnaire EORTC QLQ C-30
IV Evaluate adverse events secondary to capecitabine using Common Terminology Criteria for Adverse Events CTCAE grading system version 50
V Assess feasibility and accuracy of radiologic 3 dimensional 3D volumetric approach in measuring target lesions
EXPLORATORY OBJECTIVES
I Assess circulating tumor deoxyribonucleic acid DNA ctDNA as a low-cost alternative to imaging for measuring tumor burden
II Identify gene signatures that could predict response and identify mechanisms of resistance to capecitabine using next generation sequencing technology including
IIa Whole exome DNA sequencing from ctDNA at baseline day 0 and end of treatment IIb Whole transcriptome ribonucleic acid RNA sequencing from ctDNA at and at baseline day 0 and end of treatment
III ctDNA quantification is optional at day 1 D-1
OUTLINE
INITIAL STANDARD PHASE Patients receive standard dose of capecitabine orally PO twice daily BID on days 1-14 of each cycle Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients whose disease has responded or remains stable after 2 cycles continue to the Adaptive Phase
ADAPTIVE PHASE Patients receive 50 reduced dose of capecitabine PO BID on days 1-14 of each cycle Patients undergo blood sample collection every cycle and computed tomography CT every other cycle for disease response assessment Patients whose disease burden decreases 10 on CT or blood begins receiving an additional 50 reduced dose of capecitabine PO BID on days 1-14 of each cycle Patients whose disease burden is stable on CT or blood continue receiving initial Adaptive Phase dose of capecitabine PO BID on days 1-14 of each cycle Patients whose disease burden increases 10 on CT or blood begin receiving a 50 dose increase in capecitabine PO BID on days 1-14 of each cycle Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity
Additionally patients undergo blood sample collection CT or magnetic resonance imaging MRI and bone scan if indicated on study
After completion of study treatment patients are followed up every 3 months for up to 3 years from time of registration
I Evaluate the feasibility of adaptive therapy AT in hormone receptor positive metastatic breast cancer defined as the number of patients who can achieve AT modification for 2 or more cycles
SECONDARY OBJECTIVES
I To evaluate time to progression in patients receiving capecitabine AT defined as the interval between treatment start and tumor progression or death in patients with no evidence of disease progression
II Assess overall survival in patients receiving capecitabine as adaptive therapy
III Evaluate patient related outcomes by measuring quality of life and global health status of patients on AT using the European Organization for Research and Treatment of Cancer EORTC Quality of Life Core 30 questionnaire EORTC QLQ C-30
IV Evaluate adverse events secondary to capecitabine using Common Terminology Criteria for Adverse Events CTCAE grading system version 50
V Assess feasibility and accuracy of radiologic 3 dimensional 3D volumetric approach in measuring target lesions
EXPLORATORY OBJECTIVES
I Assess circulating tumor deoxyribonucleic acid DNA ctDNA as a low-cost alternative to imaging for measuring tumor burden
II Identify gene signatures that could predict response and identify mechanisms of resistance to capecitabine using next generation sequencing technology including
IIa Whole exome DNA sequencing from ctDNA at baseline day 0 and end of treatment IIb Whole transcriptome ribonucleic acid RNA sequencing from ctDNA at and at baseline day 0 and end of treatment
III ctDNA quantification is optional at day 1 D-1
OUTLINE
INITIAL STANDARD PHASE Patients receive standard dose of capecitabine orally PO twice daily BID on days 1-14 of each cycle Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients whose disease has responded or remains stable after 2 cycles continue to the Adaptive Phase
ADAPTIVE PHASE Patients receive 50 reduced dose of capecitabine PO BID on days 1-14 of each cycle Patients undergo blood sample collection every cycle and computed tomography CT every other cycle for disease response assessment Patients whose disease burden decreases 10 on CT or blood begins receiving an additional 50 reduced dose of capecitabine PO BID on days 1-14 of each cycle Patients whose disease burden is stable on CT or blood continue receiving initial Adaptive Phase dose of capecitabine PO BID on days 1-14 of each cycle Patients whose disease burden increases 10 on CT or blood begin receiving a 50 dose increase in capecitabine PO BID on days 1-14 of each cycle Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity
Additionally patients undergo blood sample collection CT or magnetic resonance imaging MRI and bone scan if indicated on study
After completion of study treatment patients are followed up every 3 months for up to 3 years from time of registration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None