Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06184750
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2023-12-27
Brief Title:
Finding the Best Tamoxifen Dose for Breast Cancer Risk Reduction in Premenopausal Women RENAISSANCE Trial
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Refining Tamoxifen Dose for Premenopausal Breast Cancer Risk Reduction RENAISSANCE A Phase II Single Arm Trial
Status:
RECRUITING
Status Verified Date:
2024-09
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 evaluates response-guided low-dose tamoxifen for reducing breast density in women who are at higher than average risk for breast cancer Increasing breast density is a well established risk factor for breast cancer Tamoxifen is a selective estrogen receptor modulator It works by blocking the effects of the hormone estrogen in the breast Tamoxifen has been shown to reduce breast density even at reduced dosages and is approved for the prevention of breast cancer
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate whether the overall proportion of premenopausal tamoxifen responders defined by absolute dense area reduction on mammogram of 10 can be increased through a strategy of within-individual dose escalation among non-responders from 5 mg per day to 10 mg per day
SECONDARY OBJECTIVES
I To assess the association of plasma levels of major tamoxifen metabolites with tamoxifen dose and breast density changes from baseline
II To evaluate longitudinal change from baseline in serum biomarkers of tamoxifen response at each dose level sex hormone binding globulin SHBG insulin like growth factor 1 IGF-1 and C-reactive protein CRP
III To assess the association of baseline dense area continuous variable with tamoxifen response
IV To evaluate the impact of tamoxifen dose on participant-reported symptoms Breast Eight Symptom Scale BESS
V To evaluate the impact of tamoxifen dose on adherence to final tamoxifen dose
EXPLORATORY OBJECTIVES
I To evaluate breast tissue-based biomarkers in research biopsy samples that associate with tamoxifen response at six months comparing within-person change in responders and non-responder
II To assess the association between single nucleotide polymorphisms that overlap between risk of breast cancer and dense are of breasts and others that relate to efficiency of tamoxifen metabolism
III To evaluate change in breast cancer risk estimates from baseline to 18 months as assessed by an AI artificial intelligence tool and compare changes by dose group
OUTLINE This is a within-participant dose-escalation study of tamoxifen
Participants receive tamoxifen 5mg orally PO once daily QD for 6 months Participants with absolute dense area reduction aDAR 10 on mammogram at 6 months continue receiving tamoxifen 5mg PO QD for 12 months Participants with aDAR 10 at 6 months are escalated to receive tamoxifen 10mg PO QD for 6 months Participants with aDAR 10 after 6 months of tamoxifen 10mg continue receiving tamoxifen 10 mg PO QD for 6 months Participants with aDAR 10 after 6 months of tamoxifen 10mg are given the option of continuing tamoxifen 10mg or escalating to receive tamoxifen 20mg PO QD for 6 months Participants undergo mammography and collection of blood samples at screening and on study Participants may optionally undergo biopsy at screening and on study
After completion of study intervention patients are followed up at 4 weeks
I To evaluate whether the overall proportion of premenopausal tamoxifen responders defined by absolute dense area reduction on mammogram of 10 can be increased through a strategy of within-individual dose escalation among non-responders from 5 mg per day to 10 mg per day
SECONDARY OBJECTIVES
I To assess the association of plasma levels of major tamoxifen metabolites with tamoxifen dose and breast density changes from baseline
II To evaluate longitudinal change from baseline in serum biomarkers of tamoxifen response at each dose level sex hormone binding globulin SHBG insulin like growth factor 1 IGF-1 and C-reactive protein CRP
III To assess the association of baseline dense area continuous variable with tamoxifen response
IV To evaluate the impact of tamoxifen dose on participant-reported symptoms Breast Eight Symptom Scale BESS
V To evaluate the impact of tamoxifen dose on adherence to final tamoxifen dose
EXPLORATORY OBJECTIVES
I To evaluate breast tissue-based biomarkers in research biopsy samples that associate with tamoxifen response at six months comparing within-person change in responders and non-responder
II To assess the association between single nucleotide polymorphisms that overlap between risk of breast cancer and dense are of breasts and others that relate to efficiency of tamoxifen metabolism
III To evaluate change in breast cancer risk estimates from baseline to 18 months as assessed by an AI artificial intelligence tool and compare changes by dose group
OUTLINE This is a within-participant dose-escalation study of tamoxifen
Participants receive tamoxifen 5mg orally PO once daily QD for 6 months Participants with absolute dense area reduction aDAR 10 on mammogram at 6 months continue receiving tamoxifen 5mg PO QD for 12 months Participants with aDAR 10 at 6 months are escalated to receive tamoxifen 10mg PO QD for 6 months Participants with aDAR 10 after 6 months of tamoxifen 10mg continue receiving tamoxifen 10 mg PO QD for 6 months Participants with aDAR 10 after 6 months of tamoxifen 10mg are given the option of continuing tamoxifen 10mg or escalating to receive tamoxifen 20mg PO QD for 6 months Participants undergo mammography and collection of blood samples at screening and on study Participants may optionally undergo biopsy at screening and on study
After completion of study intervention patients are followed up at 4 weeks
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-10628 | REGISTRY | None | None |
| NCI23-14-01 | OTHER | None | None |
| INT23-14-01 | OTHER | None | None |
| NCI23-14-01 | OTHER | None | None |
| P30CA060553 | NIH | None | None |
| UG1CA242596 | NIH | None | None |
| UG1CA242609 | NIH | None | None |
| UG1CA242635 | NIH | None | None |
| UG1CA242632 | NIH | None | None |
| UG1CA242643 | NIH | CTEP | httpsreporternihgovquickSearchUG1CA242643 |