Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04891731
Status:
UNKNOWN
Last Update Posted:
2021-05-18
First Post:
2021-05-17
Brief Title:
Efficacy and Safety of Leuprorelin 3M in Premenopausal Women With Hormone Receptor-positive Breast Cancer
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
Efficacy and Safety of Leuprorelin Acetate Every-3-months Depot Plus an Aromatase Inhibitor or Tamoxifen in Premenopausal Women With Hormone Receptor-positive Breast Cancer a Clinical Prospective Observational Study
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
NOT_YET_RECRUITING
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:
Leuprorelin a LHRH agonist acts as a potent inhibitor of gonadotropin secretion and is commonly used for the treatment of hormone-responsive prostate cancer premenopausal HR breast cancer endometriosis and uterine fibroids It is currently available in 1M 3M 6M for subcutaneous administration Initially administration would stimulate an increase in LH and FSH causing a transient increase of E2 in 2-4 weeks Continuous administration results in a subsequent decrease in E2 levels as a result of decreased levels of luteinizing LH and FSH After stopping injection ovarian function could gradually recover Adverse events related to leuprorelin include flushing mood swings and urogenital symptoms
At present the treatment of premenopausal breast cancer mainly includes 1M and 3M GnRHa Leuprorelin 1125mg dosage form is currently the only 3M GnRHa in China that has gotten breast cancer indications The use of 3M GnRHa could improve patients compliance and reduce injection discomfort However previous studies about GnRHa alone or in combination with TAM or AIs usually used 1M GnRHa There have been few studies reporting the suppression effects of E2 levels and clinical outcome with leuprorelin 3M in combination with TAM or AIs
At present the treatment of premenopausal breast cancer mainly includes 1M and 3M GnRHa Leuprorelin 1125mg dosage form is currently the only 3M GnRHa in China that has gotten breast cancer indications The use of 3M GnRHa could improve patients compliance and reduce injection discomfort However previous studies about GnRHa alone or in combination with TAM or AIs usually used 1M GnRHa There have been few studies reporting the suppression effects of E2 levels and clinical outcome with leuprorelin 3M in combination with TAM or AIs
Detailed Description:
Background
There are some differences in the age of onset of breast cancer histopathological types and treatment methods between Asians and non-Asians Incidence peaks at age 40-50 in Asian women with more than half of premenopausal patients but 65-70 years in US women most of which are postmenopausal1 Besides compared with Americans Asian women younger than 50 have a higher prevalence of luminal A breast cancer and less basal-like subtype Therefore the application of OFS has always been the focus for the treatment of premenopausal women with HR breast cancer in Asia
OFS therapy includes oophorectomy ovarian radiation and the use of GnRHa Several studies have shown that the use of GnRHa in premenopausal women can achieve similar efficacy to oophorectomy and ovarian radiation therapy As GnRHa has the advantages of non-invasiveness and reversibility it has gradually replaced oophorectomy and ovarian radiation and has become the main method of OFS in premenopausal women with HR breast cancer Meanwhile GnRHa in combination with TAM or AIs is increasingly used for premenopausal HR breast cancer patients Previous studies have revealed that GnRHa alone or in combination with TAM or AIs has shown effective estrogen suppression and certain survival benefits for most patients with breast cancer In addition the 5-year follow-up results of the TEXT SOFT study in 2014 showed that compared with OFS TAM OFS AI treatment significantly improved DFS prolonged cancer-free survival time and distant recurrence-free metastasis8 9 The 9-year follow-up results of the TEXT SOFT study in 2019 indicated that OFS AI versus OFS TAM or TAM single drugs years of distant recurrence risk in patients with high risk of recurrence have an absolute benefit rate of 10-15 Intermediate risk is 4-5 low-risk benefit is not obvious In 2019 the ABCCG reviewed ESO-ESMO and St Gallens treatment recommendations for HR Her-2 negative breast cancer in premenopausal women discussed controversial issues and pointed out that patients with low recurrence risk can be treated with TAM alone For patients with high risk of recurrence chemotherapy OFS AI should be given It indicates that not all premenopausal HR patients with early breast cancer need auxiliary OFS and more clinical trials on OFSin premenopausal HR patients are necessary and worthwhile
Leuprorelin a LHRH agonist acts as a potent inhibitor of gonadotropin secretion and is commonly used for the treatment of hormone-responsive prostate cancer premenopausal HR breast cancer endometriosis and uterine fibroids It is currently available in 1M 3M 6M for subcutaneous administration Initially administration would stimulate an increase in LH and FSH causing a transient increase of E2 in 2-4 weeks Continuous administration results in a subsequent decrease in E2 levels as a result of decreased levels of luteinizing LH and FSH After stopping injection ovarian function could gradually recover Adverse events related to leuprorelin include flushing mood swings and urogenital symptoms
At present the treatment of premenopausal breast cancer mainly includes 1M and 3M GnRHa Leuprorelin 1125mg dosage form is currently the only 3M GnRHa in China that has gotten breast cancer indications The use of 3M GnRHa could improve patients compliance and reduce injection discomfort However previous studies about GnRHa alone or in combination with TAM or AIs usually used 1M GnRHa There have been few studies reporting the suppression effects of E2 levels and clinical outcome with leuprorelin 3M in combination with TAM or AIs
To further investigate the suppression effects of E2 levels of 3M GnRHa we conducted a single-arm prospective clinical observational study evaluating the efficacy and safety of adjuvant therapy with leuprorelin 3M in combination with TAM or AIs in premenopausal HR breast cancer
There are some differences in the age of onset of breast cancer histopathological types and treatment methods between Asians and non-Asians Incidence peaks at age 40-50 in Asian women with more than half of premenopausal patients but 65-70 years in US women most of which are postmenopausal1 Besides compared with Americans Asian women younger than 50 have a higher prevalence of luminal A breast cancer and less basal-like subtype Therefore the application of OFS has always been the focus for the treatment of premenopausal women with HR breast cancer in Asia
OFS therapy includes oophorectomy ovarian radiation and the use of GnRHa Several studies have shown that the use of GnRHa in premenopausal women can achieve similar efficacy to oophorectomy and ovarian radiation therapy As GnRHa has the advantages of non-invasiveness and reversibility it has gradually replaced oophorectomy and ovarian radiation and has become the main method of OFS in premenopausal women with HR breast cancer Meanwhile GnRHa in combination with TAM or AIs is increasingly used for premenopausal HR breast cancer patients Previous studies have revealed that GnRHa alone or in combination with TAM or AIs has shown effective estrogen suppression and certain survival benefits for most patients with breast cancer In addition the 5-year follow-up results of the TEXT SOFT study in 2014 showed that compared with OFS TAM OFS AI treatment significantly improved DFS prolonged cancer-free survival time and distant recurrence-free metastasis8 9 The 9-year follow-up results of the TEXT SOFT study in 2019 indicated that OFS AI versus OFS TAM or TAM single drugs years of distant recurrence risk in patients with high risk of recurrence have an absolute benefit rate of 10-15 Intermediate risk is 4-5 low-risk benefit is not obvious In 2019 the ABCCG reviewed ESO-ESMO and St Gallens treatment recommendations for HR Her-2 negative breast cancer in premenopausal women discussed controversial issues and pointed out that patients with low recurrence risk can be treated with TAM alone For patients with high risk of recurrence chemotherapy OFS AI should be given It indicates that not all premenopausal HR patients with early breast cancer need auxiliary OFS and more clinical trials on OFSin premenopausal HR patients are necessary and worthwhile
Leuprorelin a LHRH agonist acts as a potent inhibitor of gonadotropin secretion and is commonly used for the treatment of hormone-responsive prostate cancer premenopausal HR breast cancer endometriosis and uterine fibroids It is currently available in 1M 3M 6M for subcutaneous administration Initially administration would stimulate an increase in LH and FSH causing a transient increase of E2 in 2-4 weeks Continuous administration results in a subsequent decrease in E2 levels as a result of decreased levels of luteinizing LH and FSH After stopping injection ovarian function could gradually recover Adverse events related to leuprorelin include flushing mood swings and urogenital symptoms
At present the treatment of premenopausal breast cancer mainly includes 1M and 3M GnRHa Leuprorelin 1125mg dosage form is currently the only 3M GnRHa in China that has gotten breast cancer indications The use of 3M GnRHa could improve patients compliance and reduce injection discomfort However previous studies about GnRHa alone or in combination with TAM or AIs usually used 1M GnRHa There have been few studies reporting the suppression effects of E2 levels and clinical outcome with leuprorelin 3M in combination with TAM or AIs
To further investigate the suppression effects of E2 levels of 3M GnRHa we conducted a single-arm prospective clinical observational study evaluating the efficacy and safety of adjuvant therapy with leuprorelin 3M in combination with TAM or AIs in premenopausal HR breast cancer
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