Trial · NCT02066532
Ruxolitinib in Combination With Trastuzumab in Metastatic HER2 Positive Breast Cancer
NCT02066532, Phase 1, Phase 2, Completed, Dawn L. Hershman; results first posted 2023-08-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ruxolitinib in Combination With Trastuzumab in Metastatic HER2 Positive Breast Cancer. Trials, record NCT02066532. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02066532
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ruxolitinib in Combination With Trastuzumab in Metastatic HER2 Positive Breast Cancer
- NCT number
- NCT02066532
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 32 participants, actual
- Lead sponsor
- Dawn L. Hershman
- Conditions
- Metastatic Breast Cancer, Breast Carcinoma, HER-2 Positive Breast Cancer
- Interventions
- Ruxolitinib, Trastuzumab
- First posted
- 2014-02-19
- Last updated
- 2023-08-24
- Results first posted
- 2023-08-24
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose of Ruxolitinib in Combination With Trastuzumab (Phase I) | Up to 15 weeks | The maximum tolerated dose (MTD) combination is defined as the dose combination associated with a target probability of dose limiting toxicity (DLT) of 0.25. A dose-limiting toxicity is defined as the MTD with DLTs defined as any grade 3 non-hematologic toxicities despite maximal supportive care or any grade 4 hematologic toxicity. The MTD will be estimated using the time to event continual reassessment method (TITE-CRM). The TITE-CRM will use an empirical dose-toxicity model, with a sample size of 10. The dose-toxicity model is calibrated such that the method will eventually select a dose that yields between 16% and 34% DLT. |
| Primary | Progression Free Survival (PFS) (Phase II) | Up to 24 weeks | Progression free survival (PFS) will be measured every 3 cycles (9 weeks of treatment +/- 4 days). PFS will be defined as the time from patient registration until objective or disease progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
| Secondary | Objective Response Rate (Phase II) | Up to 24 weeks | Participants will be reviewed at 24 weeks to determine the objective response rate, which is defined as the number of participants with a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1. |
| Secondary | Number of Participants With Adverse Events (Phase II) | Up to 6 years | All phase II participants were evaluated for toxicity from the time of their first treatment with the study drugs. The frequency of subjects experiencing toxicities will be tabulated using the Canter Therapies Evaluation Program (CTEP) Active Version of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 4.0). |
| Secondary | Clinical Benefit Ratio (CBR) (Phase II) | 24 weeks | CBR defined as complete response, partial response, or stable disease for \>24 weeks in the phase II portion |
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 | Maximum Tolerated Dose of Ruxolitinib in Combination With Trastuzumab (Phase I) | Up to 15 weeks | milligrams | NUMBER | |
| PRIMARY | Progression Free Survival (PFS) (Phase II) | Up to 24 weeks | Phase II participants | Weeks | MEDIAN |
| SECONDARY | Objective Response Rate (Phase II) | Up to 24 weeks | Phase II participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events (Phase II) | Up to 6 years | Phase II participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Benefit Ratio (CBR) (Phase II) | 24 weeks | Phase II participants | participants | NUMBER |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose of Ruxolitinib in Combination With Trastuzumab (Phase I) | Ruxolitinib/Trastuzumab | 25 | milligrams | ||
| Progression Free Survival (PFS) (Phase II) | Ruxolitinib/Trastuzumab | 8.3 | 95% Confidence Interval 7.1 to 13.9 | Weeks | |
| Objective Response Rate (Phase II) | Ruxolitinib/Trastuzumab | 1 | Participants | ||
| Number of Participants With Adverse Events (Phase II) | Ruxolitinib/Trastuzumab | 26 | Participants | ||
| Clinical Benefit Ratio (CBR) (Phase II) | Ruxolitinib/Trastuzumab | 4 | participants |
Source ClinicalTrials.gov
Participant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase I | STARTED | Ruxolitinib (25mg)/Trastuzumab | 9 | |
| Phase I | STARTED | Ruxolitinib (20mg)/ Trastuzumab | 1 | |
| Phase I | STARTED | Ruxolitinib (15 mg)/ Trastuzumab | 0 | |
| Phase I | STARTED | Ruxolitinib (10 mg)/ Trastuzumab | 0 | |
| Phase I | COMPLETED | Ruxolitinib (25mg)/Trastuzumab | 9 | |
| Phase I | COMPLETED | Ruxolitinib (20mg)/ Trastuzumab | 1 | |
| Phase I | COMPLETED | Ruxolitinib (15 mg)/ Trastuzumab | 0 | |
| Phase I | COMPLETED | Ruxolitinib (10 mg)/ Trastuzumab | 0 | |
| Phase I | NOT COMPLETED | Ruxolitinib (25mg)/Trastuzumab | 0 | |
| Phase I | NOT COMPLETED | Ruxolitinib (20mg)/ Trastuzumab | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events123
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 | Pain in extremity | General disorders | Phase 1 and 2: Ruxolitinib/Trastuzumab (25 mg) | 1 | 26 | |
| other | Muscle weakness, upper limb | Musculoskeletal and connective tissue disorders | Phase 1 and 2: Ruxolitinib/Trastuzumab (25 mg) | 1 | 26 | |
| other | Anemia | Blood and lymphatic system disorders | Phase 1 and 2: Ruxolitinib/Trastuzumab (25 mg) | 14 | 26 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Phase 1 and 2: Ruxolitinib/Trastuzumab (25 mg) | 2 | 26 | |
| other | Urinary Incontinence | Renal and urinary disorders | Phase 1 and 2: Ruxolitinib/Trastuzumab (25 mg) | 1 | 26 | |
| other | Eye Disorder | Eye disorders | Phase 1 and 2: Ruxolitinib/Trastuzumab (25 mg) | 2 | 26 | |
| other | Abdominal Pain | Gastrointestinal disorders | Phase 1 and 2: Ruxolitinib/Trastuzumab (25 mg) | 1 | 26 | |
| other | Alanine aminotransferase increase | Blood and lymphatic system disorders | Phase 1 and 2: Ruxolitinib/Trastuzumab (25 mg) | 5 | 26 | |
| other | Alkaline phosphatase increased | Blood and lymphatic system disorders | Phase 1 and 2: Ruxolitinib/Trastuzumab (25 mg) | 4 | 26 | |
| other | Allergic rhinitis | Immune system disorders | Phase 1 and 2: Ruxolitinib/Trastuzumab (25 mg) | 1 | 26 |
1 to 10 of 123Source ClinicalTrials.gov
See all 123 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1 and 2: Ruxolitinib/Trastuzumab (25 mg) | 4 | 26 |
| Total, other adverse events | Phase 1 and 2: Ruxolitinib/Trastuzumab (25 mg) | 26 | 26 |
| Total, serious adverse events | Phase 1 and 2: Ruxolitinib/Trastuzumab (25 mg) | 8 | 26 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01CA168426 | Systems Biology of Tumor Progression and Drug Resistance | CALIFANO, ANDREA | COLUMBIA UNIVERSITY HEALTH SCIENCES | NATIONAL CANCER INSTITUTE | 2012 to 2016 |
Source NIH RePORTER
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/NCT02066532
GET https://conductscience.org/api/trials/v1/NCT02066532/flow?page=2