Trial · NCT02448420
Study of Palbociclib and Trastuzumab With Endocrine Therapy in HER2-positive Metastatic Breast Cancer
NCT02448420, Phase 2, Completed, SOLTI Breast Cancer Research Group
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Palbociclib and Trastuzumab With Endocrine Therapy in HER2-positive Metastatic Breast Cancer. Trials, record NCT02448420. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02448420
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Palbociclib and Trastuzumab With Endocrine Therapy in HER2-positive Metastatic Breast Cancer
- NCT number
- NCT02448420
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 73 participants, actual
- Lead sponsor
- SOLTI Breast Cancer Research Group
- Conditions
- Metastatic Breast Cancer
- Interventions
- Palbociclib, Trastuzumab, Endocrine therapy, Chemotherapy, Antibody-Drug Conjugates
- First posted
- 2015-05-19
- Last updated
- 2024-04-18
- Other registries' IDs
- eudract:2014-005006-38
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival at 6 months | From randomization date to date of first documentation of progression or death , whichever came first, assessed up to 6 months. | For cohorts A,B1 and B2: This was defined as the proportion of patients alive and without progression (according to RECIST v1.1 criteria), 6 months after randomization. |
| Primary | Progression-Free Survival (PFS)as Assessed by the Investigator [ Time Frame: From randomization date to date of first documentation of progression or death | From randomization date to date of first documentation of progression or death , whichever came first, assessed up to 4 years | For cohorts C: This will be defined as the proportion of patients alive and without progression (according to RECIST v1.1 criteria) |
| Secondary | Rate of Disease control rate (DCR) in treatment arms (A and B) | up to 5 years | Number of patients with objective response (complete or partial) or stable disease according to RECIST 1.1 criteria for at least 12 weeks. |
| Secondary | Rate of Overall tumour objective response rate (ORR) in treatment arms (A and B). | up to 5 years | Number of patients who achieve complete or partial response according to RECIST 1.1 criteria during treatment. |
| Secondary | Evaluation of time to progression (Cohorts A and B) | up to 5 years | Time between treatment start and disease progression |
| Secondary | Cardiac Safety profile in arms A and B: Percentage of Participants with cardiac adverse events | up to 5 years | Frequency of cardiac events of any grade, frequency of grade III-IV grade cardiac events according to NYHA classification. |
| Secondary | Overall Survival in treatment arms (Cohorts A and B). | up to 5 years | Measured as time between treatment start and all-cause death. |
| Secondary | Rate of Disease control rate (DCR) in both treatment arms (C1 and C2) | up to 4 years | Number of patients with objective response (complete or partial) or stable disease according to RECIST 1.1 criteria for at least 8 weeks. |
| Secondary | Rate of Overall tumour objective response rate (ORR) in treatment arms (C1 and C2). | up to 4 years | Number of patients who achieve complete or partial response according to RECIST 1.1 criteria during treatment. |
| Secondary | Median duration of response in both treatment arms (C1 and C2). | up to 4 years | Time of median duration of response according to RECIST 1.1 by treatment arm. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
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 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/NCT02448420
GET https://conductscience.org/api/trials/v1/NCT02448420/registered