Trial · NCT02876302
Study Of Ruxolitinib (INCB018424) With Preoperative Chemotherapy For Triple Negative Inflammatory Breast Cancer
NCT02876302, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2024-04-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Of Ruxolitinib (INCB018424) With Preoperative Chemotherapy For Triple Negative Inflammatory Breast Cancer. Trials, record NCT02876302. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02876302
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Of Ruxolitinib (INCB018424) With Preoperative Chemotherapy For Triple Negative Inflammatory Breast Cancer
- NCT number
- NCT02876302
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Inflammatory Breast Cancer (IBC)
- Interventions
- Ruxolitinib, Paclitaxel, Doxorubicin, Cyclophosphamide
- First posted
- 2016-08-23
- Last updated
- 2026-07-24
- Results first posted
- 2024-04-18
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Biologic Response To 7-Day Run-In Window Phase Treatment of Ruxolitinib Alone or Ruxolitinib Plus Paclitaxel | 7 days | Biologic response to 7-day run-in phase treatment, defined as a change in phosphorylated STAT3 (pSTAT3) expression from moderate/high positive (pSTAT3-positive) in pre-run-in phase sample to negative or weakly positive/equivocal (pSTAT3-negative) in post-run-in samples. pSTAT3 status was determined by evaluating the percent positive cells and the strength of staining (weak vs. strong/moderate) in relation to positive and negative controls. A T-score was calculated based on percent-stained cells and intensity of staining and interpreted as follows: Scores 0-4 are negative/weakly positive (pStat3 negative) and 5-8 are moderate/high positive (pStat3 positive). Hence, pStat3 negative indicates a biologic response or a decrease in pSTAT3 levels. |
| Secondary | Pathologic Complete Response Rate (pCR) After Preoperative Therapy | 28 weeks | Pathologic Complete Response rate (pCR) is defined as the absence of invasive carcinoma within the breast and axillary lymph nodes following preoperative therapy. |
| Secondary | Assess Change in STAT3 Gene Expression Following run-in Treatment | 7 Days | Change of STAT3 gene expression between pretreatment and post-ruxolitinib run-in (after 7 days of ruxolitinib alone or with one dose of weekly paclitaxel) biopsy specimens. RNA-seq was performed on a subset of tumor pairs (n=4 per run-in treatment group). Enrichment analysis for JAK-STAT and IL-6 Hallmark signatures obtained a Gene Set Variation Analysis (GSVA) enrichment score as a measure of STAT3 gene expression. The GSVA enrichment score is a continuous unitless measure that summarizes joint expression of multiple genes into a single value. A positive value indicates greater, and a negative value a lesser, enrichment of pathway signatures; thus a negative pre- to post-runin change in the value indicates a decrease in the STAT3 expression after the treatment, and a positive values indicates increase in STAT3 expression after treatment. |
| Secondary | Determine Efficacy Defined as Disease-Free Survival (DFS) | 2 years | Disease-Free Survival (DFS) is defined as time of surgery, among the subset of patients who underwent surgery (n=21), until occurrence of recurrence, contralateral cancer, death attributable to any cause, second primary cancer other than breast. DFS was censored at date of last assessment. |
| Secondary | Determine Efficacy Defined as Time to Treatment Failure (TTF) | 2 years | The endpoint is now more commonly known as event-free survival (EFS). Defined as time of treatment initiation until occurrence of recurrence, contralateral cancer, death attributable to any cause, second primary cancer other than breast or occurrence of progressive disease during preoperative therapy or treatment of disease that is not surgically resectable; otherwise censored at last disease follow-up. |
| Secondary | Determine Efficacy Defined as Overall Survival (OS) | 2 years | Overall survival (OS) is defined as time from surgery until death from any cause or from treatment initiation until death from any cause. |
| Secondary | Assess Residual Cancer Burden (RCB) Differences After Preoperative Therapy | 28 weeks | Residual cancer burden (RCB) is a continuous variable (RCB0 through RCB-IV) derived from the primary tumor dimensions, cellularity of the tumor bed, and axillary nodal burden as described in Symmans et al, 2007; where RCB-0 equals pathologic complete response (pCR) and considered the best prognosis and RCB-IV is considered the worst prognosis. |
| Secondary | Changes in Interleukin 6 (IL-6) Plasma Levels During Treatment | 28 weeks | Elevations in interleukin (IL-6) and C-reactive protein (CRP) have been associated with worse clinical outcomes in patients with breast cancer. To determine whether STAT3 pathways were changed in the treatment groups, enrichment of JAKSTAT3 or IL-6 pathway-related gene signatures in the post-window phase samples compared to pre-window phase samples was analyzed. Enrichment analysis for JAK-STAT and IL-6 hallmark signatures were calculated using gene set variation analysis (GSVA) package. Each hospital followed their institutional guidelines for CRP and IL-6 measurements. |
| Secondary | Changes in C-reactive Protein (CRP) Plasma Levels During Treatment | 28 weeks | Systemic biologic responses to ruxolitinib were assessed using serum IL-6 and c-reactive protein (CRP) levels. CRP levels are associated with poor prognosis and increased inflammatory response. Therefore, CRP levels in combination with pSTAT3 staining, could potentially be used as a more reliable method to select patients who would benefit from ruxolitinib treatment. To further analyze the effect of ruxolitinib throughout treatment, serum for CRP assessment was collected from patients at pre-window phase, post-window-phase, following 12-week neoadjuvant paclitaxel with or without ruxolitinib and immediately before surgery (pre-surgery). Each hospital followed their institutional guidelines for CRP measurements. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Biologic Response To 7-Day Run-In Window Phase Treatment of Ruxolitinib Alone or Ruxolitinib Plus Paclitaxel | 7 days | A total of 23 patients were enrolled across 4 centers from January 24, 2018, to February 5, 2021. During the window phase of the trial, 11 patients received 7 days of ruxolitinib and 12 received ruxolitinib plus paclitaxel. Among 23 patients, 20 had baseline biopsy samples stained. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pathologic Complete Response Rate (pCR) After Preoperative Therapy | 28 weeks | Neoadjuvant treatment phase population including those who received single agent ruxolitinib during the window phase treatment and then proceeded to neoadjuvant therapy with daily ruxolitinib plus weekly paclitaxel for 12 weeks (n=5) and those patients who had received the combination of ruxolitinib plus paclitaxel during the window phase continued to receive it for a total of 12 weeks (n=12). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Assess Change in STAT3 Gene Expression Following run-in Treatment | 7 Days | To assess global transcriptomic changes during treatment, RNA-seq was performed on paired pre- and post-run-in phase tumor biopsy samples (n=4 per run-in treatment group). | GSVA enrichment score | MEAN |
| SECONDARY | Determine Efficacy Defined as Disease-Free Survival (DFS) | 2 years | Two patients whose disease progressed during neoadjuvant therapy did not have surgery; the other 21 patients proceeded to surgery and radiation therapy. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Determine Efficacy Defined as Time to Treatment Failure (TTF) | 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Determine Efficacy Defined as Overall Survival (OS) | 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Assess Residual Cancer Burden (RCB) Differences After Preoperative Therapy | 28 weeks | Subset (n=15, patients allocated to ruxolitinib plus paclitaxel given as neoadjuvant therapy) of the overall patient population allocated to ruxolitinib plus paclitaxel given as neoadjuvant therapy (n=17) who had tumor samples at both baseline and 28 wk timepoints. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Changes in Interleukin 6 (IL-6) Plasma Levels During Treatment | 28 weeks | Subset (n=4, patients allocated to paclitaxel alone as neoadjuvant therapy; n=13, patients allocated to ruxolitinib plus paclitaxel given as neoadjuvant therapy) of the overall population allocated to neoadjuvant therapy (n=6; n=17, respectively) who had blood samples successfully assayed at both baseline and 28 wk timepoints. | picograms per milliliter | MEDIAN |
| SECONDARY | Changes in C-reactive Protein (CRP) Plasma Levels During Treatment | 28 weeks | Subset (n=4, patients allocated to paclitaxel alone as neoadjuvant therapy; n=14, patients allocated to ruxolitinib plus paclitaxel given as neoadjuvant therapy) of the overall population allocated to neoadjuvant therapy (n=6; n=17, respectively) who had blood samples successfully assayed at both baseline and 28 wk timepoints. | milligram per liter | MEDIAN |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Biologic Response To 7-Day Run-In Window Phase Treatment of Ruxolitinib Alone or Ruxolitinib Plus Paclitaxel | Ruxolitinib Alone First | pStat3 negative | 2 | Participants | |
| Biologic Response To 7-Day Run-In Window Phase Treatment of Ruxolitinib Alone or Ruxolitinib Plus Paclitaxel | Ruxolitinib Plus Paclitaxel First | pStat3 negative | 3 | Participants | |
| Biologic Response To 7-Day Run-In Window Phase Treatment of Ruxolitinib Alone or Ruxolitinib Plus Paclitaxel | Ruxolitinib Alone First | pStat3 positive | 9 | Participants | |
| Biologic Response To 7-Day Run-In Window Phase Treatment of Ruxolitinib Alone or Ruxolitinib Plus Paclitaxel | Ruxolitinib Plus Paclitaxel First | pStat3 positive | 6 | Participants | |
| Biologic Response To 7-Day Run-In Window Phase Treatment of Ruxolitinib Alone or Ruxolitinib Plus Paclitaxel | Ruxolitinib Alone First | Baseline pStat3 status not available | 0 | Participants | |
| Biologic Response To 7-Day Run-In Window Phase Treatment of Ruxolitinib Alone or Ruxolitinib Plus Paclitaxel | Ruxolitinib Plus Paclitaxel First | Baseline pStat3 status not available | 3 | Participants | |
| Pathologic Complete Response Rate (pCR) After Preoperative Therapy | Paclitaxel Alone Given As Neoadjuvant Therapy, After Ruxolitinib Alone First | pCR in breast and lymph nodes - No | 5 | Participants | |
| Pathologic Complete Response Rate (pCR) After Preoperative Therapy | Ruxolitinib Plus Paclitaxel Given As Neoadjuvant Therapy | pCR in breast and lymph nodes - No | 16 | Participants | |
| Pathologic Complete Response Rate (pCR) After Preoperative Therapy | Paclitaxel Alone Given As Neoadjuvant Therapy, After Ruxolitinib Alone First | pCR in breast and lymph nodes - Yes | 1 | Participants | |
| Pathologic Complete Response Rate (pCR) After Preoperative Therapy | Ruxolitinib Plus Paclitaxel Given As Neoadjuvant Therapy | pCR in breast and lymph nodes - Yes | 1 | Participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Run-In Treatment Phase | STARTED | Ruxolitinib Alone First | 11 | |
| Run-In Treatment Phase | STARTED | Ruxolitinib Plus Paclitaxel First | 12 | |
| Run-In Treatment Phase | COMPLETED | Ruxolitinib Alone First | 11 | |
| Run-In Treatment Phase | COMPLETED | Ruxolitinib Plus Paclitaxel First | 12 | |
| Run-In Treatment Phase | NOT COMPLETED | Ruxolitinib Alone First | 0 | |
| Run-In Treatment Phase | NOT COMPLETED | Ruxolitinib Plus Paclitaxel First | 0 | |
| Neoadjuvant Treatment Phase | STARTED | Ruxolitinib Alone First | 11 | |
| Neoadjuvant Treatment Phase | STARTED | Ruxolitinib Plus Paclitaxel First | 12 | |
| Neoadjuvant Treatment Phase | Treated with neoadjuvant paclitaxel Only | Ruxolitinib Alone First | 6 | |
| Neoadjuvant Treatment Phase | Treated with neoadjuvant paclitaxel Only | Ruxolitinib Plus Paclitaxel First | 0 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events264
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 | Ruxolitinib Alone First | 0 | 11 | |
| other | Anemia | Blood and lymphatic system disorders | Ruxolitinib Plus Paclitaxel First | 0 | 12 | |
| other | Anemia | Blood and lymphatic system disorders | Paclitaxel Alone Given As Neoadjuvant Therapy | 1 | 6 | |
| other | Anemia | Blood and lymphatic system disorders | Ruxolitinib Plus Paclitaxel Given As Neoadjuvant Therapy | 11 | 17 | |
| other | Lymph node pain | Blood and lymphatic system disorders | Ruxolitinib Alone First | 0 | 11 | |
| other | Lymph node pain | Blood and lymphatic system disorders | Ruxolitinib Plus Paclitaxel First | 0 | 12 | |
| other | Lymph node pain | Blood and lymphatic system disorders | Paclitaxel Alone Given As Neoadjuvant Therapy | 1 | 6 | |
| other | Lymph node pain | Blood and lymphatic system disorders | Ruxolitinib Plus Paclitaxel Given As Neoadjuvant Therapy | 0 | 17 | |
| other | Dry eye | Eye disorders | Ruxolitinib Alone First | 0 | 11 | |
| other | Dry eye | Eye disorders | Ruxolitinib Plus Paclitaxel First | 0 | 12 |
1 to 10 of 264Source ClinicalTrials.gov
See all 264 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ruxolitinib Alone First | 0 | 11 |
| Total, all-cause mortality | Ruxolitinib Plus Paclitaxel First | 0 | 12 |
| Total, all-cause mortality | Paclitaxel Alone Given As Neoadjuvant Therapy | 3 | 6 |
| Total, all-cause mortality | Ruxolitinib Plus Paclitaxel Given As Neoadjuvant Therapy | 5 | 17 |
| Total, other adverse events | Ruxolitinib Alone First | 4 | 11 |
| Total, other adverse events | Ruxolitinib Plus Paclitaxel First | 9 | 12 |
| Total, other adverse events | Paclitaxel Alone Given As Neoadjuvant Therapy | 6 | 6 |
| Total, other adverse events | Ruxolitinib Plus Paclitaxel Given As Neoadjuvant Therapy | 17 | 17 |
| Total, serious adverse events | Ruxolitinib Alone First | 0 | 11 |
| Total, serious adverse events | Ruxolitinib Plus Paclitaxel First | 2 | 12 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38297352 | DERIVED |
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.
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