Trial · NCT01077154
Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE)
NCT01077154, Phase 3, Terminated, Amgen; results first posted 2018-10-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE). Trials, record NCT01077154. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01077154
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE)
- NCT number
- NCT01077154
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 4,509 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Breast Cancer
- Interventions
- Placebo, Denosumab
- First posted
- 2010-02-26
- Last updated
- 2021-09-28
- Other registries' IDs
- eudract:2009-011299-32
- Results first posted
- 2018-10-03
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Bone Metastasis-free Survival (BMFS) | From randomization until the primary analysis data cut-off date of 31 August 2017; median (minimum, maximum) time on study was 67.2 (0.0, 85.9) and 67.0 (0.0, 86.6) months in each treatment group respectively. | BMFS time was defined as the time interval from the randomization date to the first occurrence of bone metastasis or death from any cause, whichever came first. Participants last known to be alive with no bone metastasis were censored at their last assessment date, or at the primary analysis data cut-off date, whichever was first. Participants who had first occurrence of bone metastasis before randomization were censored at their randomization date. Bone metastasis must have been confirmed by central imaging analysis or by biopsy, Evidence of disseminated tumor cells in bone marrow was not sufficient for determination of disease recurrence. Development of new primary malignancy in bone was not considered as bone metastasis. Since the median BMSF time could not be estimated due to low number of events, the percentage of participants with an event (i.e., bone metastasis or death) is reported. |
| Secondary | Disease-free Survival (DFS) | From randomization until the primary analysis data cut-off date of 31 August 2017; median (minimum, maximum) time on study was 67.2 (0.0, 85.9) and 67.0 (0.0, 86.6) months in each treatment group respectively. | DFS time was defined as the time interval from the randomization date to the date of first observation of disease recurrence or death from any cause, whichever was first. Participants last known to be alive with no disease recurrence were censored at their last assessment date, or at the primary analysis data cut-off date, whichever was first. Participants who had first disease recurrence before randomization were censored at their randomization date. Disease recurrence includes bone metastasis and extraosseous disease (EOD) confirmed by central imaging analysis or by biopsy/cytology. Development of non-breast cancer new primary malignancy was not considered as disease recurrence. Since the median DFS time could not be estimated due to low number of events, the percentage of participants with an event (i.e., disease recurrence or death) is reported. |
| Secondary | Disease-free Survival (DFS) in the Postmenopausal Subset | From randomization until the primary analysis data cut-off date of 31 August 2017; median (minimum, maximum) time on study was 67.2 (0.0, 85.9) and 67.0 (0.0, 86.6) months in each treatment group respectively. | DFS time was defined as the time interval from the randomization date to the date of first observation of disease recurrence or death from any cause, whichever was first. Participants last known to be alive with no disease recurrence were censored at their last assessment date, or at the primary analysis data cut-off date, whichever was first. Participants who had first disease recurrence before randomization were censored at their randomization date. Disease recurrence includes bone metastasis and extraosseous disease (EOD) confirmed by central imaging analysis or by biopsy/cytology. Development of non-breast cancer new primary malignancy was not considered as disease recurrence. Since the median DFS time in the postmenopausal subset could not be estimated due to low number of events, the percentage of participants with an event (i.e., disease recurrence or death) is reported. |
| Secondary | Overall Survival | From randomization until the end of study; median (minimum, maximum) time on study was 72.7 (0, 92) and 72.3 (0, 92) months in each treatment group respectively. | Overall survival (OS) time was defined as the time interval from the randomization date to the date of death from any cause. Participants last known to be alive were censored at their last contact date. Since the median time to overall survival could not be estimated at the time of the final analysis due to low numbers of events, the percentage of participants with an event (i.e., death) is reported. |
| Secondary | Distant Recurrence-free Survival | From randomization until the primary analysis data cut-off date of 31 August 2017; median (minimum, maximum) time on study was 67.2 (0.0, 85.9) and 67.0 (0.0, 86.6) months in each treatment group respectively. | Distant recurrence-free survival (DRFS) was defined as the time interval from the randomization date to the date of first observation of distant disease recurrence or death from any cause, whichever came first. Participants last known to be alive, who had not experienced distant disease recurrence, were censored at their last assessment date, or at the primary analysis data cut-off date, whichever was first. Participants who had first distant recurrence before randomization were censored at their randomization date. Distant disease recurrence includes confirmed bone metastasis and extraosseous disease other than local-regional disease recurrence. Development of non-breast cancer new primary malignancy was not considered as distant disease recurrence. Since the median time to DRFS could not be estimated due to the low number of events, the percentage of participants with an event (i.e., distant recurrence or death) is reported. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Bone Metastasis-free Survival (BMFS) | From randomization until the primary analysis data cut-off date of 31 August 2017; median (minimum, maximum) time on study was 67.2 (0.0, 85.9) and 67.0 (0.0, 86.6) months in each treatment group respectively. | All randomized participants | percentage of participants | NUMBER |
| SECONDARY | Disease-free Survival (DFS) | From randomization until the primary analysis data cut-off date of 31 August 2017; median (minimum, maximum) time on study was 67.2 (0.0, 85.9) and 67.0 (0.0, 86.6) months in each treatment group respectively. | All randomized participants | percentage of participants | NUMBER |
| SECONDARY | Disease-free Survival (DFS) in the Postmenopausal Subset | From randomization until the primary analysis data cut-off date of 31 August 2017; median (minimum, maximum) time on study was 67.2 (0.0, 85.9) and 67.0 (0.0, 86.6) months in each treatment group respectively. | Randomized participants postmenopausal at enrollment, defined as:~* Undergone bilateral oophorectomy~* Age ≥ 60 years~* Age 45 to 59 years with 1 of the criteria, ie, either amenorrhea \> 12 months with an intact uterus and ≥ 1 intact ovary; or amenorrhea for ≤ 12 months and follicle-stimulating hormone and estradiol in postmenopausal range. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival | From randomization until the end of study; median (minimum, maximum) time on study was 72.7 (0, 92) and 72.3 (0, 92) months in each treatment group respectively. | All randomized participants | percentage of participants | NUMBER |
| SECONDARY | Distant Recurrence-free Survival | From randomization until the primary analysis data cut-off date of 31 August 2017; median (minimum, maximum) time on study was 67.2 (0.0, 85.9) and 67.0 (0.0, 86.6) months in each treatment group respectively. | All randomized participants | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Bone Metastasis-free Survival (BMFS) | Placebo | 13.5 | 95% Confidence Interval 12.1 to 15.0 | percentage of participants | |
| Bone Metastasis-free Survival (BMFS) | Denosumab | 12.9 | 95% Confidence Interval 11.6 to 14.3 | percentage of participants | |
| Disease-free Survival (DFS) | Placebo | 19.2 | 95% Confidence Interval 17.6 to 20.8 | percentage of participants | |
| Disease-free Survival (DFS) | Denosumab | 19.6 | 95% Confidence Interval 18.0 to 21.2 | percentage of participants | |
| Disease-free Survival (DFS) in the Postmenopausal Subset | Placebo | 18.6 | 95% Confidence Interval 16.3 to 20.9 | percentage of participants | |
| Disease-free Survival (DFS) in the Postmenopausal Subset | Denosumab | 20.3 | 95% Confidence Interval 17.8 to 22.7 | percentage of participants | |
| Overall Survival | Placebo | 9.5 | 95% Confidence Interval 8.3 to 10.8 | percentage of participants | |
| Overall Survival | Denosumab | 9.5 | 95% Confidence Interval 8.3 to 10.7 | percentage of participants | |
| Distant Recurrence-free Survival | Placebo | 18.0 | 95% Confidence Interval 16.4 to 19.6 | percentage of participants | |
| Distant Recurrence-free Survival | Denosumab | 18.7 | 95% Confidence Interval 17.1 to 20.3 | percentage of participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 2,253 | |
| Overall Study | STARTED | Denosumab | 2,256 | |
| Overall Study | Received Study Drug | Placebo | 2,229 | |
| Overall Study | Received Study Drug | Denosumab | 2,230 | |
| Overall Study | COMPLETED | Placebo | 27 | |
| Overall Study | COMPLETED | Denosumab | 28 | |
| Overall Study | NOT COMPLETED | Placebo | 2,226 | |
| Overall Study | NOT COMPLETED | Denosumab | 2,228 |
Source ClinicalTrials.gov
Adverse events1,548
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 349 | 2,218 | |
| other | Anaemia | Blood and lymphatic system disorders | Denosumab | 354 | 2,241 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo | 154 | 2,218 | |
| other | Leukopenia | Blood and lymphatic system disorders | Denosumab | 145 | 2,241 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo | 461 | 2,218 | |
| other | Neutropenia | Blood and lymphatic system disorders | Denosumab | 441 | 2,241 | |
| other | Lacrimation increased | Eye disorders | Placebo | 243 | 2,218 | |
| other | Lacrimation increased | Eye disorders | Denosumab | 195 | 2,241 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 242 | 2,218 | |
| other | Abdominal pain | Gastrointestinal disorders | Denosumab | 232 | 2,241 |
1 to 10 of 1,548Source ClinicalTrials.gov
See all 1,548 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 215 | 2,218 |
| Total, all-cause mortality | Denosumab | 215 | 2,241 |
| Total, other adverse events | Placebo | 2,123 | 2,218 |
| Total, other adverse events | Denosumab | 2,149 | 2,241 |
| Total, serious adverse events | Placebo | 675 | 2,218 |
| Total, serious adverse events | Denosumab | 702 | 2,241 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Denosumab vs Placebo: deaths from any cause | Trial comparisons |
| Denosumab vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01077154
GET https://conductscience.org/api/trials/v1/NCT01077154/events?page=2