Trial Outcomes & Findings for Survival Endpoints in Women Treated for Metastatic Breast Cancer: Contribution of Real-life Databases (NCT NCT03676257)
NCT ID: NCT03676257
Last Updated: 2025-12-10
Results Overview
OS was defined as the time from diagnosis of mBC to the date of death from any cause.
Recruitment status
COMPLETED
Target enrollment
20033 participants
Primary outcome timeframe
10 years
Results posted on
2025-12-10
Participant Flow
Participant milestones
| Measure |
Women With a Diagnosis of HR+ /HER2- Metastatic Breast Cancer (mBC)
Women with a diagnosis of HR+ /HER2- metastatic breast cancer (mBC) and satisfying eligibility criteria
|
Women With a Diagnosis of HR- /HER2- Metastatic Breast Cancer (mBC)
Women with a diagnosis of HR- /HER2- metastatic breast cancer (mBC) and satisfying eligibility criteria
|
Women With a Diagnosis of HR+ /HER2+ Metastatic Breast Cancer (mBC)
Women with a diagnosis of HR+ /HER2+ metastatic breast cancer (mBC) and satisfying eligibility criteria
|
Women With a Diagnosis of HR- /HER2+ Metastatic Breast Cancer (mBC)
Women with a diagnosis of HR- /HER2+ metastatic breast cancer (mBC) and satisfying eligibility criteria
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13283
|
2845
|
2502
|
1403
|
|
Overall Study
COMPLETED
|
13283
|
2845
|
2502
|
1403
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Women With a Diagnosis of HR+ /HER2- Metastatic Breast Cancer (mBC)
n=13283 Participants
Women with a diagnosis of HR+ /HER2- metastatic breast cancer (mBC) and satisfying eligibility criteria
|
Women With a Diagnosis of HR- /HER2- Metastatic Breast Cancer (mBC)
n=2845 Participants
Women with a diagnosis of HR- /HER2- metastatic breast cancer (mBC) and satisfying eligibility criteria
|
Women With a Diagnosis of HR+ /HER2+ Metastatic Breast Cancer (mBC)
n=2502 Participants
Women with a diagnosis of HR+ /HER2+ metastatic breast cancer (mBC) and satisfying eligibility criteria
|
Women With a Diagnosis of HR- /HER2+ Metastatic Breast Cancer (mBC)
n=1403 Participants
Women with a diagnosis of HR- /HER2+ metastatic breast cancer (mBC) and satisfying eligibility criteria
|
Total
n=20033 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62 years
n=13283 Participants
|
56 years
n=2845 Participants
|
57 years
n=2502 Participants
|
56 years
n=1403 Participants
|
60 years
n=20033 Participants
|
|
Sex: Female, Male
Female
|
13283 Participants
n=13283 Participants
|
2845 Participants
n=2845 Participants
|
2502 Participants
n=2502 Participants
|
1403 Participants
n=1403 Participants
|
20033 Participants
n=20033 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=13283 Participants
|
0 Participants
n=2845 Participants
|
0 Participants
n=2502 Participants
|
0 Participants
n=1403 Participants
|
0 Participants
n=20033 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
France
|
13283 Participants
n=13283 Participants
|
2845 Participants
n=2845 Participants
|
2502 Participants
n=2502 Participants
|
1403 Participants
n=1403 Participants
|
20033 Participants
n=20033 Participants
|
|
Grade
Grade 1
|
1532 Participants
n=13283 Participants
|
46 Participants
n=2845 Participants
|
132 Participants
n=2502 Participants
|
16 Participants
n=1403 Participants
|
1726 Participants
n=20033 Participants
|
|
Grade
Grade 2
|
6883 Participants
n=13283 Participants
|
758 Participants
n=2845 Participants
|
1125 Participants
n=2502 Participants
|
459 Participants
n=1403 Participants
|
9225 Participants
n=20033 Participants
|
|
Grade
Grade 3
|
2775 Participants
n=13283 Participants
|
1662 Participants
n=2845 Participants
|
866 Participants
n=2502 Participants
|
724 Participants
n=1403 Participants
|
6027 Participants
n=20033 Participants
|
|
Grade
Grade not documented
|
2093 Participants
n=13283 Participants
|
379 Participants
n=2845 Participants
|
379 Participants
n=2502 Participants
|
204 Participants
n=1403 Participants
|
3055 Participants
n=20033 Participants
|
PRIMARY outcome
Timeframe: 10 yearsPopulation: OS is reported for major combinations of treatments. For the combination of treatments "OTHER", OS is not reported given the populations are highly heterogeneous, and therefore reporting OS is not clinically relevant. When the number of participants in a row is "0", this means that the combinbation of treatments (defined by the row) was provided to 0 woman of the population (defined by the column).
OS was defined as the time from diagnosis of mBC to the date of death from any cause.
Outcome measures
| Measure |
Women With a Diagnosis of HR+ /HER2+ Metastatic Breast Cancer (mBC)
n=2306 Participants
Women with a diagnosis of HR+ /HER2+ metastatic breast cancer (mBC) and satisfying eligibility criteria
|
Women With a Diagnosis of HR- /HER2+ Metastatic Breast Cancer (mBC)
n=1239 Participants
Women with a diagnosis of HR- /HER2+ metastatic breast cancer (mBC) and satisfying eligibility criteria
|
Women With a Diagnosis of HR+ /HER2- Metastatic Breast Cancer (mBC)
n=13268 Participants
Women with a diagnosis of HR+ /HER2- metastatic breast cancer (mBC) and satisfying eligibility criteria
|
Women With a Diagnosis of HR- /HER2- Metastatic Breast Cancer (mBC)
n=2725 Participants
Women with a diagnosis of HR- /HER2- metastatic breast cancer (mBC) and satisfying eligibility criteria
|
|---|---|---|---|---|
|
Overall Survival (OS) for Commonly Prescribed First-line Treatment Strategies
Combination of endocrine therapy and chemotherapy
|
29.5 months
Interval 24.8 to 46.3
|
—
|
48.5 months
Interval 46.1 to 50.3
|
—
|
|
Overall Survival (OS) for Commonly Prescribed First-line Treatment Strategies
Combination of endocrine therapy and targeted treatment
|
56.3 months
Interval 46.2 to 79.4
|
—
|
58.8 months
Interval 49.5 to 69.3
|
—
|
|
Overall Survival (OS) for Commonly Prescribed First-line Treatment Strategies
Combination of chemotherapy, endocrine therapy and targeted treatment
|
86.1 months
Interval 74.5 to 97.7
|
—
|
42.6 months
Interval 40.8 to 46.0
|
—
|
|
Overall Survival (OS) for Commonly Prescribed First-line Treatment Strategies
Endocrine therapy (exclusive)
|
40.3 months
Interval 36.9 to 49.4
|
—
|
48.8 months
Interval 47.3 to 50.2
|
—
|
|
Overall Survival (OS) for Commonly Prescribed First-line Treatment Strategies
Chemotherapy and targeted treatment
|
47.6 months
Interval 41.3 to 55.0
|
43.8 months
Interval 40.2 to 49.1
|
27.8 months
Interval 25.0 to 29.9
|
15.8 months
Interval 14.9 to 17.7
|
|
Overall Survival (OS) for Commonly Prescribed First-line Treatment Strategies
Chemotherapy (exclusive)
|
30.9 months
Interval 23.3 to 38.7
|
17.4 months
Interval 11.0 to 20.6
|
23.7 months
Interval 22.2 to 25.9
|
13.5 months
Interval 12.6 to 14.3
|
SECONDARY outcome
Timeframe: 10 yearsPopulation: rwPFS is reported for major combinations of treatments. For the combination of treatments "OTHER", rwPFS is not reported given the populations are highly heterogeneous, and therefore reporting rwPFS is not clinically relevant. When the number of participants in a row is "0", this means that the combinbation of treatments (defined by the row) was provided to 0 woman of the population (defined by the column).
rwPFS was defined as the delay between time from initial diagnosis of mBC to the date of disease progression (regional recurrence, progression, appearance/occurrence of metastases and distant recurrence) or death (any cause), whichever came first. Disease progression was assessed by the treating physician based on observed clinical events, as per routine practice (regional recurrence, progression, appearance/occurrence of metastases and distant recurrence). These events were recorded in the patient medical record. As this study relates to real-world data, no specific procedure was imposed to assess these events.
Outcome measures
| Measure |
Women With a Diagnosis of HR+ /HER2+ Metastatic Breast Cancer (mBC)
n=2306 Participants
Women with a diagnosis of HR+ /HER2+ metastatic breast cancer (mBC) and satisfying eligibility criteria
|
Women With a Diagnosis of HR- /HER2+ Metastatic Breast Cancer (mBC)
n=1239 Participants
Women with a diagnosis of HR- /HER2+ metastatic breast cancer (mBC) and satisfying eligibility criteria
|
Women With a Diagnosis of HR+ /HER2- Metastatic Breast Cancer (mBC)
n=13268 Participants
Women with a diagnosis of HR+ /HER2- metastatic breast cancer (mBC) and satisfying eligibility criteria
|
Women With a Diagnosis of HR- /HER2- Metastatic Breast Cancer (mBC)
n=2725 Participants
Women with a diagnosis of HR- /HER2- metastatic breast cancer (mBC) and satisfying eligibility criteria
|
|---|---|---|---|---|
|
Real-world Progression-free Survival (rwPFS) for Commonly Prescribed First-line Treatment Strategies
Chemotherapy (exclusive)
|
4.4 months
Interval 3.5 to 5.4
|
4.4 months
Interval 3.5 to 6.0
|
5.0 months
Interval 4.8 to 5.2
|
5.4 months
Interval 5.1 to 5.8
|
|
Real-world Progression-free Survival (rwPFS) for Commonly Prescribed First-line Treatment Strategies
Endocrine therapy (exclusive)
|
5.9 months
Interval 5.2 to 7.1
|
—
|
12.5 months
Interval 12.0 to 13.0
|
—
|
|
Real-world Progression-free Survival (rwPFS) for Commonly Prescribed First-line Treatment Strategies
Combination of endocrine therapy and chemotherapy
|
9.3 months
Interval 7.5 to 11.5
|
—
|
16.2 months
Interval 15.4 to 16.7
|
—
|
|
Real-world Progression-free Survival (rwPFS) for Commonly Prescribed First-line Treatment Strategies
Chemotherapy and targeted treatment
|
9.9 months
Interval 8.4 to 10.9
|
12.3 months
Interval 11.3 to 13.0
|
7.2 months
Interval 6.7 to 7.8
|
6.5 months
Interval 6.1 to 6.8
|
|
Real-world Progression-free Survival (rwPFS) for Commonly Prescribed First-line Treatment Strategies
Combination of chemotherapy, endocrine therapy and targeted treatment
|
24.6 months
Interval 22.8 to 27.0
|
—
|
14.5 months
Interval 13.8 to 15.1
|
—
|
|
Real-world Progression-free Survival (rwPFS) for Commonly Prescribed First-line Treatment Strategies
Combination of endocrine therapy and targeted treatment
|
12.2 months
Interval 9.9 to 15.8
|
—
|
19.4 months
Interval 15.7 to 23.1
|
—
|
SECONDARY outcome
Timeframe: 10 yearsPopulation: Individual-level association between rwPFS and OS is reported for major combinations of treatments. For the combination "OTHER", this individual-level association is not reported given the populations are highly heterogeneous, and therefore reporting ondividual-level association is not clinically relevant. When the number of participants in a row is "0", this means that the combinbation of treatments (defined by the row) was provided to 0 woman of the population (defined by the column).
Individual-level association between rwPFS and OS estimated using a Spearman rank correlation coefficient.
Outcome measures
| Measure |
Women With a Diagnosis of HR+ /HER2+ Metastatic Breast Cancer (mBC)
n=2306 Participants
Women with a diagnosis of HR+ /HER2+ metastatic breast cancer (mBC) and satisfying eligibility criteria
|
Women With a Diagnosis of HR- /HER2+ Metastatic Breast Cancer (mBC)
n=1239 Participants
Women with a diagnosis of HR- /HER2+ metastatic breast cancer (mBC) and satisfying eligibility criteria
|
Women With a Diagnosis of HR+ /HER2- Metastatic Breast Cancer (mBC)
n=13268 Participants
Women with a diagnosis of HR+ /HER2- metastatic breast cancer (mBC) and satisfying eligibility criteria
|
Women With a Diagnosis of HR- /HER2- Metastatic Breast Cancer (mBC)
n=2725 Participants
Women with a diagnosis of HR- /HER2- metastatic breast cancer (mBC) and satisfying eligibility criteria
|
|---|---|---|---|---|
|
Association Between Overall Survival and Real-world Progression-free Survival for Commonly Prescribed First-line Treatment Strategies
Combination of chemotherapy, endocrine therapy and targeted treatment
|
0.78 Correlation coefficient
Interval 0.74 to 0.82
|
—
|
0.7 Correlation coefficient
Interval 0.67 to 0.73
|
—
|
|
Association Between Overall Survival and Real-world Progression-free Survival for Commonly Prescribed First-line Treatment Strategies
Chemotherapy (exclusive)
|
0.33 Correlation coefficient
Interval 0.12 to 0.52
|
0.67 Correlation coefficient
Interval 0.51 to 0.78
|
0.58 Correlation coefficient
Interval 0.54 to 0.61
|
0.81 Correlation coefficient
Interval 0.79 to 0.82
|
|
Association Between Overall Survival and Real-world Progression-free Survival for Commonly Prescribed First-line Treatment Strategies
Endocrine therapy (exclusive)
|
0.43 Correlation coefficient
Interval 0.32 to 0.53
|
—
|
0.66 Correlation coefficient
Interval 0.64 to 0.68
|
—
|
|
Association Between Overall Survival and Real-world Progression-free Survival for Commonly Prescribed First-line Treatment Strategies
Combination of endocrine therapy and chemotherapy
|
0.72 Correlation coefficient
Interval 0.58 to 0.82
|
—
|
0.78 Correlation coefficient
Interval 0.76 to 0.79
|
—
|
|
Association Between Overall Survival and Real-world Progression-free Survival for Commonly Prescribed First-line Treatment Strategies
Chemotherapy and targeted treatment
|
0.67 Correlation coefficient
Interval 0.61 to 0.72
|
0.81 Correlation coefficient
Interval 0.78 to 0.84
|
0.45 Correlation coefficient
Interval 0.39 to 0.51
|
0.73 Correlation coefficient
Interval 0.69 to 0.76
|
|
Association Between Overall Survival and Real-world Progression-free Survival for Commonly Prescribed First-line Treatment Strategies
Combination of endocrine therapy and targeted treatment
|
0.71 Correlation coefficient
Interval 0.61 to 0.78
|
—
|
0.61 Correlation coefficient
Interval 0.51 to 0.7
|
—
|
Adverse Events
Women With a Diagnosis of HR+ /HER2- Metastatic Breast Cancer (mBC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Women With a Diagnosis of HR- /HER2- Metastatic Breast Cancer (mBC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Women With a Diagnosis of HR+ /HER2+ Metastatic Breast Cancer (mBC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Women With a Diagnosis of HR- /HER2+ Metastatic Breast Cancer (mBC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place