Trial · NCT02513394
PALbociclib CoLlaborative Adjuvant Study
NCT02513394, Phase 3, Active not recruiting, Alliance Foundation Trials, LLC.; results first posted 2022-04-13
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. PALbociclib CoLlaborative Adjuvant Study. Trials, record NCT02513394. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02513394
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PALbociclib CoLlaborative Adjuvant Study
- NCT number
- NCT02513394
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 5,796 participants, actual
- Lead sponsor
- Alliance Foundation Trials, LLC.
- Conditions
- Breast Cancer
- Interventions
- Palbociclib, Standard Adjuvant Endocrine Therapy
- First posted
- 2015-07-31
- Last updated
- 2026-06-15
- Other registries' IDs
- eudract:2014-005181-30
- Results first posted
- 2022-04-13
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Invasive Disease Free Survival (iDFS) | 4 years | Invasive disease-free survival (iDFS) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed HR+/HER2- invasive early breast cancer (EBC) at 4 years. iDFS is defined as the time from randomization to the date of the first event: local/regional invasive ipsilateral recurrence, contralateral invasive breast cancer, distant recurrence, second primary invasive cancer of non-breast origin or death from any cause. Direct comparison between arms used time to iDFS events and Kaplan-Meier Log-rank analysis. Due to the medians not yet achieved, the percentage of patients considered iDFS at 4 years is reported. |
| Secondary | Invasive Disease Free Survival (iDFS) Excluding Second Primary Invasive Cancers of Non-breast Origin. | 4 years | Invasive disease-free survival (iDFS, excluding second primary invasive cancers of non-breast origin) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed HR+/HER2- invasive early breast cancer (EBC) at 4 years. iDFS excluding second primary invasive cancers of non-breast origin is defined as the time from randomization to the date of the first event: local/regional invasive ipsilateral recurrence, contralateral invasive breast cancer, distant recurrence, or death from any cause. Second primary invasive cancers of non-breast origin will not be considered as events for this endpoint. Direct comparison between arms used time to iDFS events and Kaplan-Meier Log-rank analysis. Due to the medians not yet achieved, the percentage of patients considered iDFS at 4 years is reported. |
| Secondary | Distant Recurrence-free Survival (DRFS) | 4 years | Compare time to distant recurrence-free survival (DRFS). Distant recurrence is defined according to STEEP criteria as the time from randomization to the date of the first event: distant recurrence or death from any cause. Patients with a locoregional recurrence will continue to be followed for DRFS. Surviving patients who are event-free will be censored at: the date of last disease assessment, or withdrawal of consent to be followed, or death whichever came first. Direct comparison between arms used time to DRFS events and Kaplan-Meier Log-rank analysis. Due to the medians not yet achieved, the percentage of patients considered DRFS at 4 years is reported. |
| Secondary | Overall Survival (OS) | 4 years | Compare overall survival (OS). Overall survival is defined as the time period between randomization and death. Surviving patients classified as lost-to-follow up or having withdrawn consent to be followed will be censored at their date of last contact or withdrawal of consent to be followed, whichever occurs first. |
| Secondary | Locoregional Recurrences-free Survival (LRRFS) | 4 years | Compare locoregional recurrence-free survival (LRRFS). LRRFS is defined as the time from randomization to the date of the first event: local/regional invasive ipsilateral recurrence, contralateral invasive breast cancer, or death from any cause. Patients with second primary invasive cancers of non-breast origin or distant recurrence will be censored at the date of diagnosis. Surviving patients who are event-free will be censored at: the date of last disease assessment, or withdrawal of consent to be followed, whichever occurs first. |
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 | Invasive Disease Free Survival (iDFS) | 4 years | percentage of participants | NUMBER | |
| SECONDARY | Invasive Disease Free Survival (iDFS) Excluding Second Primary Invasive Cancers of Non-breast Origin. | 4 years | percentage of patients | NUMBER | |
| SECONDARY | Distant Recurrence-free Survival (DRFS) | 4 years | percentage of patients | NUMBER | |
| SECONDARY | Overall Survival (OS) | 4 years | percentage of patients | NUMBER | |
| SECONDARY | Locoregional Recurrences-free Survival (LRRFS) | 4 years | percentage of patients | 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 |
|---|---|---|---|---|---|
| Invasive Disease Free Survival (iDFS) | Palbociclib Plus Endocrine Therapy (Arm A) | 84.2 | percentage of participants | ||
| Invasive Disease Free Survival (iDFS) | Endocrine Therapy Alone (Arm B) | 84.5 | percentage of participants | ||
| Invasive Disease Free Survival (iDFS) Excluding Second Primary Invasive Cancers of Non-breast Origin. | Palbociclib Plus Endocrine Therapy (Arm A) | 85.4 | percentage of patients | ||
| Invasive Disease Free Survival (iDFS) Excluding Second Primary Invasive Cancers of Non-breast Origin. | Endocrine Therapy Alone (Arm B) | 86.0 | percentage of patients | ||
| Distant Recurrence-free Survival (DRFS) | Palbociclib Plus Endocrine Therapy (Arm A) | 86.2 | percentage of patients | ||
| Distant Recurrence-free Survival (DRFS) | Endocrine Therapy Alone (Arm B) | 87.8 | percentage of patients | ||
| Overall Survival (OS) | Palbociclib Plus Endocrine Therapy (Arm A) | 93.8 | percentage of patients | ||
| Overall Survival (OS) | Endocrine Therapy Alone (Arm B) | 95.2 | percentage of patients | ||
| Locoregional Recurrences-free Survival (LRRFS) | Palbociclib Plus Endocrine Therapy (Arm A) | 96.8 | percentage of patients | ||
| Locoregional Recurrences-free Survival (LRRFS) | Endocrine Therapy Alone (Arm B) | 95.4 | percentage of patients |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Palbociclib Plus Endocrine Therapy (Arm A) | 2,896 | |
| Overall Study | STARTED | Endocrine Therapy Alone (Arm B) | 2,900 | |
| Overall Study | COMPLETED | Palbociclib Plus Endocrine Therapy (Arm A) | 2,884 | |
| Overall Study | COMPLETED | Endocrine Therapy Alone (Arm B) | 2,877 | |
| Overall Study | NOT COMPLETED | Palbociclib Plus Endocrine Therapy (Arm A) | 12 | |
| Overall Study | NOT COMPLETED | Endocrine Therapy Alone (Arm B) | 23 |
Source ClinicalTrials.gov
Adverse events4,058
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 | Agitation Mood Disturbance | Psychiatric disorders | Palbociclib Plus Endocrine Therapy (Arm A) | 0 | 2,841 | 0 |
| other | Agitation Mood Disturbance | Psychiatric disorders | Endocrine Therapy Alone (Arm B) | 1 | 2,902 | 1 |
| other | Veritgo | Ear and labyrinth disorders | Palbociclib Plus Endocrine Therapy (Arm A) | 1 | 2,841 | 1 |
| other | Veritgo | Ear and labyrinth disorders | Endocrine Therapy Alone (Arm B) | 0 | 2,902 | 0 |
| other | Agranulocytosis | Blood and lymphatic system disorders | Palbociclib Plus Endocrine Therapy (Arm A) | 3 | 2,841 | 3 |
| other | Agranulocytosis | Blood and lymphatic system disorders | Endocrine Therapy Alone (Arm B) | 0 | 2,902 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Palbociclib Plus Endocrine Therapy (Arm A) | 634 | 2,841 | 1,161 |
| other | Anaemia | Blood and lymphatic system disorders | Endocrine Therapy Alone (Arm B) | 147 | 2,902 | 211 |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | Palbociclib Plus Endocrine Therapy (Arm A) | 4 | 2,841 | 6 |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | Endocrine Therapy Alone (Arm B) | 0 | 2,902 | 0 |
1 to 10 of 4,058Source ClinicalTrials.gov
See all 4,058 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Palbociclib Plus Endocrine Therapy (Arm A) | 99 | 2,841 |
| Total, all-cause mortality | Endocrine Therapy Alone (Arm B) | 76 | 2,902 |
| Total, other adverse events | Palbociclib Plus Endocrine Therapy (Arm A) | 2,824 | 2,841 |
| Total, other adverse events | Endocrine Therapy Alone (Arm B) | 2,600 | 2,902 |
| Total, serious adverse events | Palbociclib Plus Endocrine Therapy (Arm A) | 369 | 2,841 |
| Total, serious adverse events | Endocrine Therapy Alone (Arm B) | 229 | 2,902 |
Source ClinicalTrials.gov
Papers8
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 |
|---|---|
| Palbociclib Plus Endocrine Therapy (Arm A) vs Endocrine Therapy Alone (Arm B): deaths from any cause | Trial comparisons |
| Palbociclib Plus Endocrine Therapy (Arm A) vs Endocrine Therapy Alone (Arm B): 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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT02513394
GET https://conductscience.org/api/trials/v1/NCT02513394/events?page=2