Trial · NCT01864746
A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery
NCT01864746, Phase 3, Completed, GBG Forschungs GmbH; results first posted 2023-12-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery. Trials, record NCT01864746. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01864746
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery
- NCT number
- NCT01864746
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,250 participants, actual
- Lead sponsor
- GBG Forschungs GmbH
- Conditions
- Breast Cancer, Hormonreceptor Positive, Her2-normal, Postneoadjuvant Treatment With CDK 4/6 Inhibitor, CPS-EG Score
- Interventions
- Palbociclib PD-0332991, Placebo
- First posted
- 2013-05-30
- Last updated
- 2023-12-12
- Other registries' IDs
- eudract:2013-001040-62
- Results first posted
- 2023-12-12
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Invasive Disease Free Survival (iDFS) for Palbociclib vs. Placebo in Patients With High CPS-EG Score After Neoadjuvant Chemotherapy Receiving Standard Adjuvant Endocrine Therapy for HR-positive/HER2-normal Primary Breast Cancer. | From date of randomisation to data cut off: 24 August 2020 (approximately 6 years and 6 months) | Invasive disease-free survival (iDFS) is defined according to Hudis (J Clin Oncol 2007) as the time period between randomization and first event (ipsi- or contralateral invasive in-breast or loco-regional recurrence, distant recurrence, death from breast cancer, death from non-breast cancer cause, death from unknown cause, invasive contralateral breast cancer, second primary invasive cancer (non-breast)) assessed until the end of study. |
| Secondary | iDFS Excluding Second Non-breast Cancers | From date of randomisation to data cut off: 24 August 2020 (approximately 6 years and 6 months) | Invasive disease-free survival (iDFS) is defined according to Hudis (J Clin Oncol 2007) as the time period between randomization and first event assessed until the end of study. |
| Secondary | Distant Disease Free Survival (DDFS) | From date of randomisation to data cut off: 24 August 2020 (approximately 6 years and 6 months) | Distant disease free survival (DDFS) is defined as the time period between randomization and diagnosis of first distant breast cancer recurrences assessed until the end of study. |
| Secondary | Overall Survival (OS) | From date of randomisation to data cut off: 24 August 2020 (approximately 6 years and 6 months) | Overall survival (OS) is defined as the time period between randomization and death of any cause assessed until the end of study. |
Source ClinicalTrials.gov
Outcomes4
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) for Palbociclib vs. Placebo in Patients With High CPS-EG Score After Neoadjuvant Chemotherapy Receiving Standard Adjuvant Endocrine Therapy for HR-positive/HER2-normal Primary Breast Cancer. | From date of randomisation to data cut off: 24 August 2020 (approximately 6 years and 6 months) | Intention-to-treat population | % of patients without invasive disease | NUMBER |
| SECONDARY | iDFS Excluding Second Non-breast Cancers | From date of randomisation to data cut off: 24 August 2020 (approximately 6 years and 6 months) | Intention-to-treat population | % of patients free of event | NUMBER |
| SECONDARY | Distant Disease Free Survival (DDFS) | From date of randomisation to data cut off: 24 August 2020 (approximately 6 years and 6 months) | Intention-to-treat population | % of patients free of event | NUMBER |
| SECONDARY | Overall Survival (OS) | From date of randomisation to data cut off: 24 August 2020 (approximately 6 years and 6 months) | Intention-to-treat analysis | % of patients free of event | NUMBER |
Source ClinicalTrials.gov
Results by group16
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) for Palbociclib vs. Placebo in Patients With High CPS-EG Score After Neoadjuvant Chemotherapy Receiving Standard Adjuvant Endocrine Therapy for HR-positive/HER2-normal Primary Breast Cancer. | Palbociclib | 3-year iDFS | 81.2 | 95% Confidence Interval 77.8 to 84.1 | % of patients without invasive disease |
Invasive Disease Free Survival (iDFS) for Palbociclib vs. Placebo in Patients With High CPS-EG Score After Neoadjuvant Chemotherapy Receiving Standard Adjuvant Endocrine Therapy for HR-positive/HER2-normal Primary Breast Cancer. | Placebo | 3-year iDFS | 77.7 | 95% Confidence Interval 74.1 to 80.9 | % of patients without invasive disease |
Invasive Disease Free Survival (iDFS) for Palbociclib vs. Placebo in Patients With High CPS-EG Score After Neoadjuvant Chemotherapy Receiving Standard Adjuvant Endocrine Therapy for HR-positive/HER2-normal Primary Breast Cancer. | Palbociclib | 5-year iDFS | 63.6 | 95% Confidence Interval 56.4 to 69.9 | % of patients without invasive disease |
Invasive Disease Free Survival (iDFS) for Palbociclib vs. Placebo in Patients With High CPS-EG Score After Neoadjuvant Chemotherapy Receiving Standard Adjuvant Endocrine Therapy for HR-positive/HER2-normal Primary Breast Cancer. | Placebo | 5-year iDFS | 67.9 | 95% Confidence Interval 61.6 to 73.3 | % of patients without invasive disease |
| iDFS Excluding Second Non-breast Cancers | Palbociclib | 3-year iDFS | 82 | 95% Confidence Interval 78.6 to 84.9 | % of patients free of event |
| iDFS Excluding Second Non-breast Cancers | Placebo | 3-year iDFS | 78.5 | 95% Confidence Interval 75 to 81.7 | % of patients free of event |
| iDFS Excluding Second Non-breast Cancers | Palbociclib | 5-year iDFS | 64 | 95% Confidence Interval 56.6 to 70.4 | % of patients free of event |
| iDFS Excluding Second Non-breast Cancers | Placebo | 5-year iDFS | 68.6 | 95% Confidence Interval 62.4 to 74.1 | % of patients free of event |
| Distant Disease Free Survival (DDFS) | Palbociclib | 3-year DDFS | 82.4 | 95% Confidence Interval 79.1 to 85.3 | % of patients free of event |
| Distant Disease Free Survival (DDFS) | Placebo | 3-year DDFS | 80 | 95% Confidence Interval 76.6 to 83.1 | % of patients free of event |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Palbociclib | 631 | |
| Overall Study | STARTED | Placebo | 619 | |
| Overall Study | Started Treatment | Palbociclib | 628 | |
| Overall Study | Started Treatment | Placebo | 616 | |
| Overall Study | Safety Population | Palbociclib | 633 | |
| Overall Study | Safety Population | Placebo | 611 | |
| Overall Study | COMPLETED | Palbociclib | 508 | |
| Overall Study | COMPLETED | Placebo | 523 | |
| Overall Study | NOT COMPLETED | Palbociclib | 123 | |
| Overall Study | NOT COMPLETED | Placebo | 96 |
Source ClinicalTrials.gov
Adverse events168
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 | Hot flush | Vascular disorders | Palbociclib | 277 | 633 | |
| other | Hot flush | Vascular disorders | Placebo | 311 | 611 | |
| other | Hypertension | Vascular disorders | Palbociclib | 54 | 633 | |
| other | Hypertension | Vascular disorders | Placebo | 60 | 611 | |
| other | Embolism | Vascular disorders | Palbociclib | 13 | 633 | |
| other | Embolism | Vascular disorders | Placebo | 7 | 611 | |
| other | Fatigue | General disorders | Palbociclib | 420 | 633 | |
| other | Fatigue | General disorders | Placebo | 312 | 611 | |
| other | Peripheral edema | General disorders | Palbociclib | 126 | 633 | |
| other | Peripheral edema | General disorders | Placebo | 99 | 611 |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Palbociclib | 63 | 633 |
| Total, all-cause mortality | Placebo | 67 | 611 |
| Total, other adverse events | Palbociclib | 632 | 633 |
| Total, other adverse events | Placebo | 610 | 611 |
| Total, serious adverse events | Palbociclib | 64 | 633 |
| Total, serious adverse events | Placebo | 65 | 611 |
Source ClinicalTrials.gov
Papers10
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 vs Placebo: deaths from any cause | Trial comparisons |
| Palbociclib 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/NCT01864746
GET https://conductscience.org/api/trials/v1/NCT01864746/events?page=2