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| Name | Class |
|---|---|
| Incyte Corporation | INDUSTRY |
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This research study is studying Ruxolitinib as possible treatment for Inflammatory Breast Cancer (IBC).
The Following drugs will be use in combination with Ruxolinitinib.
This is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.
The FDA (U.S. Food and Drug Administration) has not approved Ruxolitinib for Inflammatory Breast Cancer (IBC), but is has been approved for other uses.
Ruxolitinib is a newly discovered drug that has been shown to block a pathway (called the IL6/JAK/Stat pathway) that may be important in cancer, including triple negative inflammatory breast cancer. Ruxolitinib brings proteins groups together, which can result in gene (DNA) changes. These DNA changes may stop cancer cells from growing.
Paclitaxel (also called Taxol), Doxorubicin and Cyclophosphamide (also called Adriamycin and Cytoxan, ("AC")) are drugs FDA approved for breast cancer patients. They have been shown to result in death of cancer cells when given as preoperative treatment of women with inflammatory breast cancer (IBC). Laboratory studies have shown that Ruxolitinib may make Paclitaxel more effective.
In this research study, the investigators are evaluating Ruxolitinib in combination with Paclitaxel followed by the standard chemotherapy, AC. Researchers will also evaluate how the IL6/JAK/Stat pathway is affected by this combination of drugs by studying biopsies and surgical specimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel (12weeks) | Experimental | Paclitaxel is administered weekly followed by standard Doxorubicin and Dyclophosphamide (AC) given every 2 weeks for 4 cycles preoperatively
|
|
| Ruxolitinib with Paclitaxel (12weeks) | Experimental | Paclitaxel is administered with daily Ruxolitinib, followed by standard Doxorubicin and Cyclophosphamide (AC) given every 2 weeks for 4 cycles preoperatively
|
|
| Ruxolitinib and Paclitaxel (12weeks) | Experimental | Paclitaxel is administered with daily Ruxolitinib, followed by standard Doxorubicin and Cyclophosphamide (AC) given every 2 weeks for 4 cycles preoperatively
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib | Drug | 15 or 20 mg, twice daily by mouth. The run-in part of ruxolitinib lasts 7 days; The treatment of ruxolitinib part lasts 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biologic Response To 7-Day Run-In Window Phase Treatment of Ruxolitinib Alone or Ruxolitinib Plus Paclitaxel | 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. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response Rate (pCR) After Preoperative Therapy | Pathologic Complete Response rate (pCR) is defined as the absence of invasive carcinoma within the breast and axillary lymph nodes following preoperative therapy. | 28 weeks |
| Assess Change in STAT3 Gene Expression Following run-in Treatment |
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Inclusion Criteria:
Participants must have histologically confirmed invasive breast cancer. All histologic subtypes are eligible.
Patients must have known ER, PR, and HER2 status defined as triple-negative breast cancer (TNBC), defined as:
--ER and PR <10% by immunohistochemistry, and HER2-negative ( as per ASCO/CAP guidelines, defined as IHC 0 or 1+, or FISH ratio <2.0 or HER2 copy number <6.0).
Patients must have the clinical diagnosis of inflammatory breast cancer, involving an intact breast.
Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of ruxolitinib in participants <18 years of age, children are excluded from this study.
ECOG performance status 0 or 1.
Participants must have normal organ and marrow function as defined below:
Patients with evidence of extensive nodal involvement are allowed. Extensive nodal involvement is defined as metastatic disease involving any nodal region outside of the involved breast.
Patients with minimal metastatic disease involvement in bone or viscera are allowed. Minimal metastatic disease is defined as: evidence of metastatic involvement as demonstrated by imaging only, not amenable to biopsy confirmation.
Both men and women are allowed.
The effects of ruxolitinib on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry until completion of chemotherapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Ability to understand and the willingness to sign a written informed consent document.
LVEF > 50% calculated by echocardiogram (ECHO) or MUGA
Patients may have bilateral breast cancer so long as one breast meets criteria for inflammatory breast cancer, and neither breast cancer has received prior therapy
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Filipa Lynce, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38297352 | Derived | Lynce F, Stevens LE, Li Z, Brock JE, Gulvady A, Huang Y, Nakhlis F, Patel A, Force JM, Haddad TC, Ueno N, Stearns V, Wolff AC, Clark AS, Bellon JR, Richardson ET, Balko JM, Krop IE, Winer EP, Lange P, Hwang ES, King TA, Tolaney SM, Thompson A, Gupta GP, Mittendorf EA, Regan MM, Overmoyer B, Polyak K. TBCRC 039: a phase II study of preoperative ruxolitinib with or without paclitaxel for triple-negative inflammatory breast cancer. Breast Cancer Res. 2024 Jan 31;26(1):20. doi: 10.1186/s13058-024-01774-0. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ruxolitinib Alone First | Patients (n=11) receiving ruxolitinib alone (15 mg or 20mg orally, depending on initial platelet count) given in the run-in phase for 7 days. |
| FG001 | Ruxolitinib Plus Paclitaxel First |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Run-In Treatment Phase |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 6, 2021 |
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|
| Paclitaxel | Drug | 80 mg/m2, IV (in the vein) weekly for 12 weeks. |
|
|
| Doxorubicin | Drug | 60 mg/m2, IV (in the vein) every 14 days for 4 doses. |
|
|
| Cyclophosphamide | Drug | 600 mg/m2, IV (in the vein) every 14 days for 4 doses. |
|
|
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. |
| 7 Days |
| Determine Efficacy Defined as Disease-Free Survival (DFS) | 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. | 2 years |
| Determine Efficacy Defined as Time to Treatment Failure (TTF) | 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. | 2 years |
| Determine Efficacy Defined as Overall Survival (OS) | Overall survival (OS) is defined as time from surgery until death from any cause or from treatment initiation until death from any cause. | 2 years |
| Assess Residual Cancer Burden (RCB) Differences After Preoperative Therapy | 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. | 28 weeks |
| Changes in Interleukin 6 (IL-6) Plasma Levels During Treatment | 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. | 28 weeks |
| Changes in C-reactive Protein (CRP) Plasma Levels During Treatment | 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. | 28 weeks |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
Patients (n=12) receive ruxolitinib (15 mg orally) twice daily for 7 days in combination with one dose of paclitaxel (80 mg/m2; administered on day 1, denoted Cycle 0, Day 1) in the run-in phase for 7 days.
| COMPLETED |
|
| NOT COMPLETED |
|
| Neoadjuvant Treatment Phase |
|
Treatment-naïve patients received a 7-day run-in window of ruxolitinib alone or ruxolitinib plus paclitaxel. The primary endpoint objective was the percent of pSTAT3-positive pre-window phase tumors that became pSTAT3-negative. (After the window phase, those who received ruxolitinib alone proceeded to neoadjuvant therapy with either ruxolitinib plus paclitaxel or paclitaxel alone for 12 weeks; those who had received ruxolitinib plus paclitaxel continued treatment for 12 weeks.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ruxolitinib Alone First | Patients (n=11) receiving ruxolitinib alone (15 mg or 20mg orally, depending on initial platelet count) given in the run-in treatment phase for 7 days. |
| BG001 | Ruxolitinib Plus Paclitaxel First | Patients (n=12) receive ruxolitinib (15 mg orally) twice daily for 7 days in combination with one dose of paclitaxel (80 mg/m2; administered on day 1, denoted Cycle 0, Day 1) in the run-in treatment phase for 7 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Clinical N stage | According to the American Cancer Society, the N category can be assigned a letter or a number, where N0 means nearby lymph nodes do not contain cancer and the higher the number after the N (such as N1, N2, or N3), the greater the cancer spread to nearby lymph nodes. | Count of Participants | Participants |
| |||||||||||||||
| M stage | According to the American Cancer Society, the M stage is an indicator for metastasis, where M0 indicates that no distant cancer spread has been found and M1 indicates that distant spread to distant organs or tissues is present. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Biologic Response To 7-Day Run-In Window Phase Treatment of Ruxolitinib Alone or Ruxolitinib Plus Paclitaxel | 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. | 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. | Posted | Count of Participants | Participants | 7 days |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Pathologic Complete Response Rate (pCR) After Preoperative Therapy | Pathologic Complete Response rate (pCR) is defined as the absence of invasive carcinoma within the breast and axillary lymph nodes following preoperative therapy. | 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). | Posted | Count of Participants | Participants | 28 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Assess Change in STAT3 Gene Expression Following run-in Treatment | 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. | 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). | Posted | Mean | Standard Deviation | GSVA enrichment score | 7 Days | Tumor pairs | Tumor pairs |
| ||||||||||||||||||||||||||||||
| Secondary | Determine Efficacy Defined as Disease-Free Survival (DFS) | 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. | Two patients whose disease progressed during neoadjuvant therapy did not have surgery; the other 21 patients proceeded to surgery and radiation therapy. | Posted | Count of Participants | Participants | 2 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Determine Efficacy Defined as Time to Treatment Failure (TTF) | 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. | Posted | Count of Participants | Participants | 2 years |
| ||||||||||||||||||||||||||||||||||
| Secondary | Determine Efficacy Defined as Overall Survival (OS) | Overall survival (OS) is defined as time from surgery until death from any cause or from treatment initiation until death from any cause. | Posted | Count of Participants | Participants | 2 years |
| ||||||||||||||||||||||||||||||||||
| Secondary | Assess Residual Cancer Burden (RCB) Differences After Preoperative Therapy | 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. | 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. | Posted | Count of Participants | Participants | 28 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Changes in Interleukin 6 (IL-6) Plasma Levels During Treatment | 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. | 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. | Posted | Median | Inter-Quartile Range | picograms per milliliter | 28 weeks |
| ||||||||||||||||||||||||||||||||
| Secondary | Changes in C-reactive Protein (CRP) Plasma Levels During Treatment | 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. | 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. | Posted | Median | Inter-Quartile Range | milligram per liter | 28 weeks |
|
Deaths were assessed for 2 years and occurred during followup. Adverse Events were assessed for 28 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were utilized for adverse event reporting. A copy of the CTCAE version 4.0 can be downloaded from the CTEP website http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ruxolitinib Alone First | Patients (n=11) receiving ruxolitinib alone (15 mg or 20mg orally, depending on initial platelet count) given in the run-in phase for 7 days. | 0 | 11 | 0 | 11 | 4 | 11 |
| EG001 | Ruxolitinib Plus Paclitaxel First | Patients (n=12) receive ruxolitinib (15 mg orally) twice daily for 7 days in combination with one dose of paclitaxel (80 mg/m2; administered on day 1, denoted Cycle 0, Day 1) in the run-in phase for 7 days. | 0 | 12 | 2 | 12 | 9 | 12 |
| EG002 | Paclitaxel Alone Given As Neoadjuvant Therapy | Ruxolitinib alone (15 mg or 20 mg orally, depending on initial platelet count) is given in the run-in phase for 7 days. After the window phase, patients (n=6) who received ruxolitinib alone proceeded to neoadjuvant therapy with paclitaxel alone (80 mg/m2) for 12 weeks. | 3 | 6 | 0 | 6 | 6 | 6 |
| EG003 | Ruxolitinib Plus Paclitaxel Given As Neoadjuvant Therapy | After the run-in phase, patients (n=5) receiving single agent ruxolitinib (15 mg or 20 mg orally, depending on initial platelet count) twice daily for seven days, proceeded to neoadjuvant therapy with ruxolitinib plus paclitaxel for 12 weeks in addition to patients (n=12) who had received the combination of ruxolitinib plus paclitaxel (15 mg orally) twice daily for seven days in combination with one dose of paclitaxel (80 mg/m2; administered on day 1, denoted Cycle 0, Day 1) in the run-in phase, continued to receive the combination of ruxolitinib plus paclitaxel for a total of 12 weeks. | 5 | 17 | 5 | 17 | 17 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE v4.0 | Systematic Assessment | General disorders and admin site conditions |
|
| Neutrophil count decreased | Investigations | CTCAE v4.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Infusion related reaction | General disorders | CTCAE v4.0 | Systematic Assessment | General disorders and administration site conditions |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Chills | General disorders | CTCAE v4.0 | Systematic Assessment | General disorders and admin site conditions |
|
| Edema face | General disorders | CTCAE v4.0 | Systematic Assessment | General disorders and admin site conditions |
|
| Fatigue | General disorders | CTCAE v4.0 | Systematic Assessment | General disorders and admin site conditions |
|
| Fever | General disorders | CTCAE v4.0 | Systematic Assessment | General disorders and admin site conditions |
|
| Infusion related reaction | General disorders | CTCAE v4.0 | Systematic Assessment | General disorders and admin site conditions |
|
| Pain | General disorders | CTCAE v4.0 | Systematic Assessment | General disorders and admin site conditions |
|
| Skin infection | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE v4.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE v4.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE v4.0 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE v4.0 | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Psychiatric disorders - Other, specify | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Nail discoloration | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Nail loss | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Skin/subcutaneous tissue disorders; Other | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Lymphedema | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
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| Rectal hemorrhage | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
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| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v4.0 | Systematic Assessment |
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Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Filipa Lynce, MD, Principal Investigator | Dana-Farber Cancer Institute | 617-632-3800 | Filipa_Lynce@dfci.harvard.edu |
| Dec 19, 2023 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D058922 | Inflammatory Breast Neoplasms |
| D001943 | Breast Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C540383 | ruxolitinib |
| D017239 | Paclitaxel |
| D004317 | Doxorubicin |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
Not provided
Not provided
| Male |
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| Black or African American |
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| cN0 |
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| cN1 |
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| cN2 |
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| cN3 |
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| M0 |
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| M1 |
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| Baseline pStat3 status not available |
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| Ruxolitinib Plus Paclitaxel Given As Neoadjuvant Therapy |
After the run-in phase, patients (n=5) receiving single agent ruxolitinib (15 mg or 20 mg orally, depending on initial platelet count) twice daily for seven days, proceeded to neoadjuvant therapy with ruxolitinib plus paclitaxel for 12 weeks in addition to patients (n=12) who had received the combination of ruxolitinib plus paclitaxel (15 mg orally) twice daily for seven days in combination with one dose of paclitaxel (80 mg/m2; administered on day 1, denoted Cycle 0, Day 1) in the run-in phase, continued to receive the combination of ruxolitinib plus paclitaxel for a total of 12 weeks. Two weeks after the last dose of paclitaxel, all patients received neoadjuvant doxorubicin and cyclophosphamide every two weeks for four cycles. |
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| OG001 | Ruxolitinib Plus Paclitaxel Given As Neoadjuvant Therapy | After the run-in phase, patients (n=5) receiving single agent ruxolitinib (15 mg or 20 mg orally, depending on initial platelet count) twice daily for seven days, proceeded to neoadjuvant therapy with ruxolitinib plus paclitaxel for 12 weeks in addition to patients (n=12) who had received the combination of ruxolitinib plus paclitaxel (15 mg orally) twice daily for seven days in combination with one dose of paclitaxel (80 mg/m2; administered on day 1, denoted Cycle 0, Day 1) in the run-in phase, continued to receive the combination of ruxolitinib plus paclitaxel for a total of 12 weeks. Two weeks after the last dose of paclitaxel, all patients received neoadjuvant doxorubicin and cyclophosphamide every two weeks for four cycles. |
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