Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05792150
Status:
RECRUITING
Last Update Posted:
2023-09-21
First Post:
2023-02-13
Brief Title:
PROOFS-Registry - Premenopausal Women With Breast Cancer Optimally Treated With OFS
Sponsor:
West German Study Group
Organization:
West German Study Group
Study Overview
Official Title:
Real World Data and Long-term FU of Pre-Perimenopausal Women With Luminal EBC With Intermediate to High Clinical and Low Genomic Recurrence-risk Measured by MammaPrint Treated by SOC ETOFS or SOC Chemotherapy Treatment Followed by ET
Status:
RECRUITING
Status Verified Date:
2023-09
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:
PROOFS
Brief Summary:
There is only limited data for premenopausal patients in general as well as for differences in the use of OFS in the subgroups of pre- and perimenopausal patients respectively The WSG ADAPT trial data on the impact of postmenopausal status andor use of OFS within 3-4 weeks endocrine induction therapy show relevant impact of OFSpostmenopausal status on Ki-67 response also secondary amenorrhea after neo-adjuvant chemotherapy was a positive predictor of outcome due to OFS 8 9
This registry will give insights in the real-world use of OFS and the effect of secondary amenorrhea in female pre- and perimenopausal patients with or without previous use of chemotherapy and with different endocrine treatments ET - GnRH
As adherence over time 5-10 years plays a major role in the endocrine treatment the registry will follow patients treatments for up to 10 years and include QoL information
Results of MammaPrint MammaPrint Index as indicating factor for chemotherapy use and risk classification thus choice of adjuvant treatment chemotherapy OFS combined with endocrine therapy or endocrine therapy alone will be correlated to outcome under real-world conditions
Baseline treatment and relapse data shall be collected to gain further insight in the treatment paths treatment adherence and outcome of such patients
This registry will give insights in the real-world use of OFS and the effect of secondary amenorrhea in female pre- and perimenopausal patients with or without previous use of chemotherapy and with different endocrine treatments ET - GnRH
As adherence over time 5-10 years plays a major role in the endocrine treatment the registry will follow patients treatments for up to 10 years and include QoL information
Results of MammaPrint MammaPrint Index as indicating factor for chemotherapy use and risk classification thus choice of adjuvant treatment chemotherapy OFS combined with endocrine therapy or endocrine therapy alone will be correlated to outcome under real-world conditions
Baseline treatment and relapse data shall be collected to gain further insight in the treatment paths treatment adherence and outcome of such patients
Detailed Description:
This registry aims
to confirm an excellent outcome in pre-perimenopausal patients treated by endocrine therapy ovarian suppression in patients with low genomic risk by MammaPrint without chemotherapy use in a real-world setting
to evaluate management of ovarian function in patients treated by adjuvant chemotherapy according to investigator decision
to evaluate adherence to endocrine therapy - ovarian function suppression
to evaluate the prognostic impact of clinicopathological markers eg estrogen receptor ER progesterone receptor PR HER2 receptor Ki-67 at baseline and after preoperative endocrine therapy if any performed by local pathology assessment compared to genomic signature result
to assess the course of quality of life QLQ BR23 and QLQ-C30 until 5 years of treatment with OFS Baseline 3 months 6 months 12 months 18 months 2 years 3 years 4 years 5 years
In general WSG aim to assess the quality of surveillance care in younger breast cancer patients WSG want to gain knowledge about endocrine induction treatment for indication of chemotherapy followed by endocrine treatment or endocrine treatment alone Also WSG aim at changes in duration of endocrine treatment especially in high-risk patients up to 10 years and introduction of intensified endocrine therapy OFS in combination with GnRH-analogues since publication of the SOFT and TEXT trials
to confirm an excellent outcome in pre-perimenopausal patients treated by endocrine therapy ovarian suppression in patients with low genomic risk by MammaPrint without chemotherapy use in a real-world setting
to evaluate management of ovarian function in patients treated by adjuvant chemotherapy according to investigator decision
to evaluate adherence to endocrine therapy - ovarian function suppression
to evaluate the prognostic impact of clinicopathological markers eg estrogen receptor ER progesterone receptor PR HER2 receptor Ki-67 at baseline and after preoperative endocrine therapy if any performed by local pathology assessment compared to genomic signature result
to assess the course of quality of life QLQ BR23 and QLQ-C30 until 5 years of treatment with OFS Baseline 3 months 6 months 12 months 18 months 2 years 3 years 4 years 5 years
In general WSG aim to assess the quality of surveillance care in younger breast cancer patients WSG want to gain knowledge about endocrine induction treatment for indication of chemotherapy followed by endocrine treatment or endocrine treatment alone Also WSG aim at changes in duration of endocrine treatment especially in high-risk patients up to 10 years and introduction of intensified endocrine therapy OFS in combination with GnRH-analogues since publication of the SOFT and TEXT trials
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