Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-01-01 @ 4:06 AM
Study NCT ID:
NCT01124695
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
2010-05-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tamoxifen Citrate in Treating Patients With Metastatic or Recurrent Breast Cancer
Sponsor:
ECOG-ACRIN Cancer Research Group
Organization:
Study Overview
Official Title:
A Phase II Prospective Trial Correlating Progression Free Survival With CYP2D6 Activity in Patients With Metastatic Breast Cancer Treated With Single Agent Tamoxifen
Status:
COMPLETED
Status Verified Date:
2023-06
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:
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight cancer by blocking the use of estrogen by tumor cells.
PURPOSE: This phase II trial is studying how well tamoxifen citrate works in patients with metastatic or recurrent breast cancer.
PURPOSE: This phase II trial is studying how well tamoxifen citrate works in patients with metastatic or recurrent breast cancer.
Detailed Description:
OBJECTIVES:
Primary
* To correlate CYP2D6 (Cytochrome P450 2D6) score (0 vs 1-2) and progression-free survival (PFS)
Secondary
* To correlate CYP2D6 score (0 vs 1 vs 2) and PFS
* To correlate CYP2D6 score (0 vs 1-2) and the proportion of these patients who are progression-free at 6 months.
* To correlate endoxifen concentration with response
* To correlate CYP2D6 with response
* To correlate the presence of candidate estrogen receptor (ESR) 1 and 2 variant alleles, UDP-glucuronosyltransferases (UGT) 7, sulfotransferases (SULT) 1A1, other candidate genes and biomarkers to PFS and other tamoxifen related outcomes
OUTLINE: This is a multicenter study.
Patients receive oral tamoxifen citrate once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities.
Blood, plasma, and tissue samples are collected periodically for laboratory studies.
After completion of study therapy, patients are followed up every 3-6 months for 5 years.
Primary
* To correlate CYP2D6 (Cytochrome P450 2D6) score (0 vs 1-2) and progression-free survival (PFS)
Secondary
* To correlate CYP2D6 score (0 vs 1 vs 2) and PFS
* To correlate CYP2D6 score (0 vs 1-2) and the proportion of these patients who are progression-free at 6 months.
* To correlate endoxifen concentration with response
* To correlate CYP2D6 with response
* To correlate the presence of candidate estrogen receptor (ESR) 1 and 2 variant alleles, UDP-glucuronosyltransferases (UGT) 7, sulfotransferases (SULT) 1A1, other candidate genes and biomarkers to PFS and other tamoxifen related outcomes
OUTLINE: This is a multicenter study.
Patients receive oral tamoxifen citrate once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities.
Blood, plasma, and tissue samples are collected periodically for laboratory studies.
After completion of study therapy, patients are followed up every 3-6 months for 5 years.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| E3108 | OTHER | ECOG-ACRIN Cancer Research Group | View | |
| U10CA180794 | NIH | None | https://reporter.nih.gov/quic… | View |