Ignite Creation Date:
2024-05-06 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05297617
Status:
RECRUITING
Last Update Posted:
2024-02-05
First Post:
2022-03-16
Brief Title:
Deescalation of Endocrine Therapy Duration in Women With HR HER2- Breast Cancer at Very Low Risk
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Single-arm Study to De-escalate Adjuvant Endocrine Therapy Duration in Women With HR HER2- Breast Cancer at Very Low Risk of Metastasis
Status:
RECRUITING
Status Verified Date:
2024-02
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:
LESS
Brief Summary:
Hormone therapy is recommended for five years in all patients with hormone receptor-positive breast cancer but there is no consensus on its duration in low-risk tumours and especially in postmenopausal women Adjuvant endocrine therapy ET is associated with substantial side effects and long-term decreased quality of life
Moreover while it has been shown that ET provides a real benefit in reducing the relapse rate over time the deterioration in quality of life may also have a negative effect on patient adherence to treatment It is therefore important to offer treatment to women with low-risk cancer less intensive treatment strategies If recent trials tested longer durations as compared to 5 years for high-risk cancers older trials have tested shorter durations The 5-year duration appeared at that time as the gold standard because of optimal benefit-risk ratios of tamoxifen among high-risk patients However shorter treatments of 2-3 years were already associated with substantial benefits and may be enough for very low risk patients
Moreover while it has been shown that ET provides a real benefit in reducing the relapse rate over time the deterioration in quality of life may also have a negative effect on patient adherence to treatment It is therefore important to offer treatment to women with low-risk cancer less intensive treatment strategies If recent trials tested longer durations as compared to 5 years for high-risk cancers older trials have tested shorter durations The 5-year duration appeared at that time as the gold standard because of optimal benefit-risk ratios of tamoxifen among high-risk patients However shorter treatments of 2-3 years were already associated with substantial benefits and may be enough for very low risk patients
Detailed Description:
Adjuvant ET is the cornerstone treatment of localized hormone-receptor positive breast cancer with demonstrated benefits on overall survival 30-40 relative decrease in mortality but also on the risk of local and contralateral relapse 43-50 relative decrease While the relative benefit of 5 years ET is identical for small tumors as compared to larger ones the absolute benefit is much lower and the risk-benefit ratio may therefore become very questionable given the frequent and impactful side effects of ET If recent trials tested longer durations as compared to 5 years for high-risk cancers older trials have tested shorter durations Five years appeared at that time as the gold standard because of optimal benefit-risk ratios of tamoxifen among rather high-risk patients However shorter treatments of 2-3 years were already associated with substantial benefits and may be enough for very low risk patients The purpose of this study is to demonstrate that adjuvant hormone therapy limited to 2 years of antiaromatase in postmenopausal women with a good prognosis can ensure very high survival without metastatic relapse and allows a reduction of side effects and a better quality of life The 5-year DMFS was excellent in patients with low risk Luminal A tumors who received endocrine therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| 2021-002889-41 | EUDRACT_NUMBER | None | None |