An observational study in Female Breast Cancer, sponsored by Women's Cancer Study Group GmbH. Recruiting at 71 sites in Germany. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Women's Cancer Study Group GmbH · Observational
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 and/or use of OFS within 3-4 weeks endocrine induction therapy show relevant impact of OFS/postmenopausal 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 aims
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 1,470 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Women's Cancer Study Group GmbH is the lead sponsor of 5 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For this registry, it is planned to screen N=3000 pre- and perimenopausal patients with early breast cancer who meet the inclusion criteria, i.e., intermediate to high clinical risk for recurrence, and who will receive or have received a routine genomic testing by MammaPrint® with a low/ultralow genomic risk.
It is anticipated that 75% of these patients will be nodal negative and 25% nodal positive.
Patients are eligible for participation in the registry only if they meet all the following criteria:
Exclusion Criteria:
Patients will not be eligible for the registry for any of the following reasons:
5-year distant recurrence-free interval (dRFI, according to STEEP criteria version 2.0)
dRFIin all patients treated by (intensified) endocrine therapy alone (and with ovarian suppression in cases with enhanced clinical risk according to current AGO-recommendations)
Time frame: 5 years
10-year dRFI
dRFI, according to STEEP criteria 2.0, in all patients treated by (intensified) endocrine therapy alone (with ovarian suppression in cases with higher clinical risk)
Time frame: 10 years
5-year dRFI
dRFI, according to STEEP criteria 2.0,in all patients treated by SOC chemotherapy treatment followed by ET+/-OFS
Time frame: 5 years
10-year dRFI
dRFI, according to STEEP criteria 2.0,in all patients treated by SOC chemotherapy treatment followed by ET+/-OFS
Time frame: 10 years
5-year dDFS
distant disease-free survival (dDFS, according to STEEP 2.0) in all patients and all treatment groups (i.e., patients treated by ET alone, ET + GnRH, chemotherapy followed by ET, chemotherapy followed by ET + GnRH, OFS-treated patients)
Time frame: 5 years
10-year dDFS
distant disease-free survival (dDFS, according to STEEP 2.0) in all patients and all treatment groups (i.e., patients treated by ET alone, ET + GnRH, chemotherapy followed by ET, chemotherapy followed by ET + GnRH, OFS-treated patients)treatment followed by ET+/-OFS
Time frame: 10 years
5-year OS
overall survival (OS) in all patients and all treatment groups
Time frame: 5 years
10-year OS
overall survival (OS) in all patients and all treatment groups
Time frame: 10 years
5-year breast cancer-free interval (BCFI, according to STEEP 2.0)
BCFI in all patients and all treatment groups
Time frame: 5 years
10-year breast cancer-free interval (BCFI, according to STEEP 2.0)
BCFI in all patients and all treatment groups
Time frame: 10 years
EORTC quality of life questionnaire BR23
compare the course of Qol between baseline and further defined timepoints; 23 items, symptom scales/items and functional scales/items, all of the scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning, whilst a high score for the symptom scales represents a high level of symptomatology or problems.
Time frame: every 3 months within 1st year
EORTC quality of life questionnaire C30
compare the course of Qol between baseline and further defined timepoints; 30 items, 10 subscales, the higher the rating, the worse.
Time frame: every 3 months within 1st year
EORTC quality of life questionnaire BR23
compare the course of Qol between baseline and further defined timepoints; 23 items, symptom scales/items and functional scales/items, all of the scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning, whilst a high score for the symptom scales represents a high level of symptomatology or problems.
Time frame: every 6 months within 2nd year
EORTC quality of life questionnaire C30
compare the course of Qol between baseline and further defined timepoints; 30 items, 10 subscales, the higher the rating, the worse.
Time frame: every 6 months within 2nd year
EORTC quality of life questionnaire BR23
compare the course of Qol between baseline and further defined timepoints; 23 items, symptom scales/items and functional scales/items, all of the scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning, whilst a high score for the symptom scales represents a high level of symptomatology or problems.
Time frame: yearly until 5 years
EORTC quality of life questionnaire C30
compare the course of Qol between baseline and further defined timepoints; 30 items, 10 subscales, the higher the rating, the worse.
Time frame: yearly until 5 years
adherence to OFS and endocrine treatment
Duration of intake of OFS and endocrine treatment in all patients
Time frame: 10 years
concordance between BluePrint®/MammaPrint® molecular subtyping results vs. pathological immune-histochemistry results
concordance between BluePrint®/MammaPrint® molecular subtyping results and pathological immune-histochemistry results with respect to tumour type
Time frame: 10 years
endocrine response measured by post-endocrine Ki-67
post-endocrine Ki-67 (≤10% and/or relative change vs. baseline) in patients treated by preoperative ET
Time frame: 10 years
5-year iDFS in node-negative patients with ultralow MammaPrint
node-negative patients with ultralow MammaPrint® treated by shorter duration of ET (2-3 years at investigator decision)
Time frame: 5 years
10-year iDFS in node-negative patients with ultralow MammaPrint
node-negative patients with ultralow MammaPrint® treated by shorter duration of ET (2-3 years at investigator decision)
Time frame: 10 years
Plan to share: No
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Women's Cancer Study Group GmbH