Ruxolitinib Phosphate for Metastatic Malignant Neoplasm in the Bone

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mayo Clinic in Arizona, Scottsdale, AZ
Metastatic Malignant Neoplasm in the Bone+5 More
Ruxolitinib Phosphate - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating the side effects and best dose of ruxolitinib phosphate when given together with pembrolizumab in treating patients with stage IV triple negative breast cancer that has spread to other places in the body.

See full description

Eligible Conditions

  • Metastatic Malignant Neoplasm in the Bone
  • Stage IV Breast Cancer AJCC v6 and v7
  • Triple Negative Breast Carcinoma

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Ruxolitinib Phosphate will improve 2 primary outcomes, 1 secondary outcome, and 1 other outcome in patients with Metastatic Malignant Neoplasm in the Bone. Measurement will happen over the course of Up to 21 days.

Up to 2 years
Assessment of PDJ amplification, PD-L1, PD-L2, JAK2 expression and pSTAT3
Best response
Up to 21 days
Maximum tolerated dose
Day 28
Incidence of adverse events

Trial Safety

Trial Design

1 Treatment Group

Treatment (pembrolizumab, ruxolitinib phosphate)
1 of 1
Experimental Treatment

This trial requires 18 total participants across 1 different treatment group

This trial involves a single treatment. Ruxolitinib Phosphate is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Treatment (pembrolizumab, ruxolitinib phosphate)Patients receive pembrolizumab IV over 30 minutes on day 1 and ruxolitinib phosphate PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
FDA approved
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 years for reporting.

Closest Location

Mayo Clinic in Arizona - Scottsdale, AZ

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Metastatic Malignant Neoplasm in the Bone or one of the other 5 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Metastatic (stage IV) triple negative breast cancer that has progressed after at least one prior chemotherapy regimen in the metastatic setting or refusal of chemotherapy in the metastatic setting; non-measurable disease (i.e. bone metastases) is permitted
Her2/neu by fluorescence in situ hybridization (FISH) (ratio =< 1.8) or immunohistochemistry (IHC) (0 or 1+)
Estrogen receptor (ER) and progesterone receptor (PR) expression < 10%
Absolute neutrophil count (ANC) >= 1500/mm^3 (obtained =< 7 days prior to registration)
Platelet count >= 100,000/mm^3 (obtained =< 7 days prior to registration)
Total bilirubin =< 1.5 x upper limit normal (ULN) (obtained =< 7 days prior to registration)
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN or < 5 x ULN if organ involvement (obtained =< 7 days prior to registration)
Alkaline phosphatase < 5 x ULN (obtained =< 7 days prior to registration)
Serum creatinine =< 2 x ULN or 24 hour creatinine (Cr) clearance > 60 ml/min (obtained =< 7 days prior to registration)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Patient Q&A Section

What is triple negative breast neoplasms?

"The current standard for diagnosing [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) is to first examine the breast tissue for tumors and then to take into account the histological subtype of the tumor to determine the appropriate form of treatment. Most triple-negative breast cancer patients require no adjuvant treatment due to low risk of invasive breast cancer recurrence following surgery alone. This may represent a potential bias in the current TNM classification system given that triple-negative breast cancer comprises <0.5% of breast cancer in the United States." - Anonymous Online Contributor

Unverified Answer

What are common treatments for triple negative breast neoplasms?

"Triple negative subtype is the most commonly diagnosed in the clinic setting, therefore the most common treatments are medication and surgery. No consensus was found regarding the best surgery staging; thus, no recommendation could be made." - Anonymous Online Contributor

Unverified Answer

Can triple negative breast neoplasms be cured?

"Triple negative breast neoplasms are diagnosed as stage III-IV and usually cannot be cured. Breast cancer tends to relapse or spread, but can still be diagnosed and treated at a later stage. This is the first study showing a complete tumor regression after surgery in triple negative breast neoplasms." - Anonymous Online Contributor

Unverified Answer

What are the signs of triple negative breast neoplasms?

"TNBC, which constitutes 5 to 20% of all [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer)s, are characterized by the presence of receptor-negative TNBC, basal-like subtype. Features of TNBC may include spindle-like/atypical nuclei cells with eosinophilic/basal-like cytoplasm, which are more frequent in triple-negative breast tumors. As such, spindle- and/or atypical-like nuclei cells with basal-like cytoplasms can be helpful in the differential diagnosis of TNBC." - Anonymous Online Contributor

Unverified Answer

How many people get triple negative breast neoplasms a year in the United States?

"Among women age 30+ years, the incidence of pT3 NN- breast cancer in 2007 was 1.1 per cent. Among women 20-29 years the incidence was 0.9 per cent. The incidence of pT3 NN breast cancer increased from 7.3 per cent in 1985 to 8.2 per cent in 2000. Among women aged 35+ years the incidence of pT3 NN breast cancer remained stable throughout the time period from 1996-2007." - Anonymous Online Contributor

Unverified Answer

What causes triple negative breast neoplasms?

"A unique feature of TNB is that their tumourigenic mechanism can be either p53 or PTEN mutation depending on which breast cancer subtype and which genomic aberrations are analyzed. We conclude that a specific molecular pathway for which there is a lack of knowledge is involved in the malignant progression of TNB (i.e. PTEN loss or p53 mutations)." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in ruxolitinib phosphate for therapeutic use?

"At the time of writing, ruxolitinib phosphate was still in phase III clinical trials as part of combination therapies for the treatment of patients with metastatic triple-negative breast cancer. At this time it has been approved in Japan for the treatment of relapsed adults with ALK+ ALK(T790M) or ALK(T790M) lung cancer. ALK is a tyrosine kinase receptor and its enzymatic activity is the basis for development of T790M inhibitors. ALK inhibitors are now under development by GlaxoSmithKline (GSK312701); Teva (TP-6501); BMS-470354; and Eisai (LSN7005)." - Anonymous Online Contributor

Unverified Answer

What does ruxolitinib phosphate usually treat?

"Recent findings from the current study show that ruxolitinib phosphate can be used to treat patients with TNBC-associated myelofibrosis. The addition of ruxolitinib phosphate may produce significant improvements in the outcomes of patients with TNBC and myelofibrosis." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for triple negative breast neoplasms?

"Patients with TNBC have longer survival rates than patients with breast adenocarcinomas. This knowledge will enable surgeons to decide if TNBC should be included in a multidisciplinary treatment plan for breast cancer. However, future research will be needed to determine whether the factors that contribute to the improvement of the survival rate are systemic or local." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving ruxolitinib phosphate?

"Ruxolitinib, or Sutent, a small molecule agent targeting the JAK-STAT pathway was evaluated in several small phase-3 trials for metastatic triple-negative breast cancers. In a recent study, findings show that ruxolitinib, administrated at standard dose and duration, is able to induce a very complete and durable response both in advanced and previously treated metastatic breast cancers. Most patients treated with Ruxolitinib, either maintenance or combination, experienced complete or partial (60-70%) tumor response, without serious toxicities. There is also a better performance status and quality of life compared to other chemotherapeutic regimens that used in the past." - Anonymous Online Contributor

Unverified Answer

Has ruxolitinib phosphate proven to be more effective than a placebo?

"In a recent study, findings showed no statistically significant difference in response rate between groups on the change-from-placebo analysis; moreover, the benefit in OS for patients treated with a combination of ruxolitinib and nab-paclitaxel was inconclusive; future large-scale clinical trials are needed to further assess OS improvement and identify predictive biomarkers." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing triple negative breast neoplasms?

"Based on the study findings, we conclude that there is no increased incidence of new diagnoses of triple negative breast cancer in our cohort of women. A larger population based prospective cohort study may provide more definitive evidence for this question." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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