Trial · NCT02040857
Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast Cancer
NCT02040857, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2020-12-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast Cancer. Trials, record NCT02040857. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02040857
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast Cancer
- NCT number
- NCT02040857
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 162 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Breast Cancer
- Interventions
- Palbociclib, Aromatase Inhibitor
- First posted
- 2014-01-20
- Last updated
- 2025-04-29
- Results first posted
- 2020-12-23
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 2-Year Treatment Discontinuation Rate | Evaluate upon completion of palbociclib, up to 2 years of treatment completion. | The 2-year treatment discontinuation rate is the percentage of participants who do not complete the palbociclib treatment per protocol for reasons due to toxicity, withdrawal of consent to be treated, or other events related to tolerability in uncensored participants. Participants who discontinued palbociclib early for reasons that were not treatment-related were censored. |
| Secondary | 2-year Treatment Discontinuation Rate by Aromatase Inhibitor and Tamoxifen-based Therapy Subgroup | Evaluate upon completion of palbociclib, up to 2 years of treatment completion. | The 2-year treatment discontinuation rate is the percentage of participants who do not complete the palbociclib treatment per protocol for reason due to toxicity, withdrawal of consent to be treated, or other events related to tolerability of all enrolled participants. |
| Secondary | Grade 3-4 Treatment-Related Neutropenia Toxicity Rate | AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. | Grade 3-4 treatment-related neutropenia toxicity rate is the percentage of participants experiencing at least one grade 3-4 neutropenia AE with treatment attribution of possible, probable or definite based on NCI Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4) during the time of observation on treatment as reported on case report forms. |
| Secondary | All Grade Treatment-Related Fatigue Toxicity Rate | AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. | All grade treatment-related fatigue toxicity rate is the percentage of participants experiencing at least one grade 1-4 fatigue AE with treatment attribution of possible, probable or definite based on NCI Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4) during the time of observation on treatment as reported on case report forms. |
| Secondary | All GradeTreatment-Related Alopecia Toxicity Rate | AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. | All grade treatment-related alopecia toxicity rate is the percentage of participants experiencing at least one grade 1-4 alopecia AE with treatment attribution of possible, probable or definite based on NCI Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4) during the time of observation on treatment as reported on case report forms. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 2-Year Treatment Discontinuation Rate | Evaluate upon completion of palbociclib, up to 2 years of treatment completion. | The analysis population is comprised of all uncensored participants. | percentage of participants | NUMBER |
| SECONDARY | 2-year Treatment Discontinuation Rate by Aromatase Inhibitor and Tamoxifen-based Therapy Subgroup | Evaluate upon completion of palbociclib, up to 2 years of treatment completion. | The analysis population is comprised of all enrolled participants. | percentage of participants | NUMBER |
| SECONDARY | Grade 3-4 Treatment-Related Neutropenia Toxicity Rate | AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. | The analysis population is comprised of all enrolled participants. | percentage of participants | NUMBER |
| SECONDARY | All Grade Treatment-Related Fatigue Toxicity Rate | AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. | The analysis population is comprised of all enrolled participants. | percentage of participants | NUMBER |
| SECONDARY | All GradeTreatment-Related Alopecia Toxicity Rate | AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. | The analysis population is comprised of all enrolled participants. | percentage of participants | NUMBER |
| POST_HOC | Rate of Treatment Related Discontinuation | Evaluate upon completion of combination therapy with endocrine therapy plus palbociclib, up to 2 years of treatment completion. | The analysis population is comprised of all enrolled participants. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 2-Year Treatment Discontinuation Rate | Palbociclib With Adjuvant Endocrine Therapy | 31 | 95% Confidence Interval 24 to 39 | percentage of participants | |
| 2-year Treatment Discontinuation Rate by Aromatase Inhibitor and Tamoxifen-based Therapy Subgroup | Aromatase Inhibitor + Palbociclib | 28 | 95% Confidence Interval 20 to 38 | percentage of participants | |
| 2-year Treatment Discontinuation Rate by Aromatase Inhibitor and Tamoxifen-based Therapy Subgroup | Tamoxifen + Palbociclib | 35 | 95% Confidence Interval 23 to 48 | percentage of participants | |
| Grade 3-4 Treatment-Related Neutropenia Toxicity Rate | Palbociclib With Adjuvant Endocrine Therapy | 54 | 95% Confidence Interval 46 to 62 | percentage of participants | |
| All Grade Treatment-Related Fatigue Toxicity Rate | Palbociclib With Adjuvant Endocrine Therapy | 76 | 95% Confidence Interval 69 to 82 | percentage of participants | |
| All GradeTreatment-Related Alopecia Toxicity Rate | Palbociclib With Adjuvant Endocrine Therapy | 28 | 95% Confidence Interval 22 to 36 | percentage of participants | |
| Rate of Treatment Related Discontinuation | Palbociclib With Adjuvant Endocrine Therapy | 63 | 95% Confidence Interval 55 to 70 | percentage of participants |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Palbociclib With Adjuvant Endocrine Therapy | 162 | |
| Overall Study | Treatment Discontinuation Evaluable | Palbociclib With Adjuvant Endocrine Therapy | 152 | |
| Overall Study | COMPLETED | Palbociclib With Adjuvant Endocrine Therapy | 102 | |
| Overall Study | NOT COMPLETED | Palbociclib With Adjuvant Endocrine Therapy | 60 |
Source ClinicalTrials.gov
Adverse events39
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 | Anemia | Blood and lymphatic system disorders | Palbociclib With Adjuvant Endocrine Therapy | 42 | 162 | |
| other | Lymph node pain | Blood and lymphatic system disorders | Palbociclib With Adjuvant Endocrine Therapy | 2 | 162 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Palbociclib With Adjuvant Endocrine Therapy | 3 | 162 | |
| other | Chest pain - cardiac | Cardiac disorders | Palbociclib With Adjuvant Endocrine Therapy | 1 | 162 | |
| other | Palpitations | Cardiac disorders | Palbociclib With Adjuvant Endocrine Therapy | 7 | 162 | |
| other | Sinus bradycardia | Cardiac disorders | Palbociclib With Adjuvant Endocrine Therapy | 1 | 162 | |
| other | Sinus tachycardia | Cardiac disorders | Palbociclib With Adjuvant Endocrine Therapy | 2 | 162 | |
| other | Cardiac disorders - Other, specify | Cardiac disorders | Palbociclib With Adjuvant Endocrine Therapy | 2 | 162 | |
| other | Ear pain | Ear and labyrinth disorders | Palbociclib With Adjuvant Endocrine Therapy | 2 | 162 | |
| other | Tinnitus | Ear and labyrinth disorders | Palbociclib With Adjuvant Endocrine Therapy | 4 | 162 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Palbociclib With Adjuvant Endocrine Therapy | 0 | 162 |
| Total, other adverse events | Palbociclib With Adjuvant Endocrine Therapy | 162 | 162 |
| Total, serious adverse events | Palbociclib With Adjuvant Endocrine Therapy | 96 | 162 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31250880 | RESULT |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02040857
GET https://conductscience.org/api/trials/v1/NCT02040857/events?page=2