Ruxolitinib in Patients With Breast Cancer
| Status: | Terminated |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2012 |
| End Date: | July 2014 |
Phase II Study of Ruxolitinib (INCB018424) in Patients With PSTAT3+ Breast Cancer
This research study is a Phase II clinical trial. Phase II trials test the effectiveness of
an investigational drug to learn whether the drug works in treating a specific cancer.
"Investigational" means that drug is still being studied and that research doctors are
trying to find out more about it-such as the safest dose to use, the side effects it may
cause, and if the drug is effective for treating different types of cancer. It also means
that the FDA has not approved ruxolitinib for your type of cancer.
Ruxolitinib is a drug which blocks the Janus tyrosine Kinase (JAK) signaling pathway. It is
thought that this pathway might be important in certain types of breast cancer, and that
blocking this pathway might lead to anti-cancer effects. This study is testing the effects
of ruxolitinib in patients with breast cancer.
an investigational drug to learn whether the drug works in treating a specific cancer.
"Investigational" means that drug is still being studied and that research doctors are
trying to find out more about it-such as the safest dose to use, the side effects it may
cause, and if the drug is effective for treating different types of cancer. It also means
that the FDA has not approved ruxolitinib for your type of cancer.
Ruxolitinib is a drug which blocks the Janus tyrosine Kinase (JAK) signaling pathway. It is
thought that this pathway might be important in certain types of breast cancer, and that
blocking this pathway might lead to anti-cancer effects. This study is testing the effects
of ruxolitinib in patients with breast cancer.
Tumor tissue will be tested for the presence of the pStat3 marker. Patients with a positive
test will be potentially eligible for study treatment (ruxolitinib). Patients with a
negative test will not be eligible to join the treatment portion of the study.
Participants with breast cancer that is accessible to a biopsy will undergo a research
biopsy procedure prior to beginning ruxolitinib. This biopsy is required as part of study
participation so research doctors can learn more about pSTAT3 as a marker for breast cancer.
Participatns will be given a drug-dosing calendar for each treatment cycle. Each treatment
cycle lasts 4 weeks, during which time the study drug will be taken by mouth twice a day
every day beginning on cycle 1 day 1.
During all cycles participants will undergo a physical exam, be asked questions about their
general health, be askd specific questions about any problems that they might be having and
any medications they may be taking.
Participants will also undergo blood tests, have tumor markers drawn, be asked to complete
health-realted questionnaires, and undergo body scans to assess the effects of ruxolitinib
on your tumor(s).
Partipant's medical condition will be followed for up to 2 years following study completion.
This will happen through medical record reviews as well as phone calls to the participant or
partipants' doctor.
test will be potentially eligible for study treatment (ruxolitinib). Patients with a
negative test will not be eligible to join the treatment portion of the study.
Participants with breast cancer that is accessible to a biopsy will undergo a research
biopsy procedure prior to beginning ruxolitinib. This biopsy is required as part of study
participation so research doctors can learn more about pSTAT3 as a marker for breast cancer.
Participatns will be given a drug-dosing calendar for each treatment cycle. Each treatment
cycle lasts 4 weeks, during which time the study drug will be taken by mouth twice a day
every day beginning on cycle 1 day 1.
During all cycles participants will undergo a physical exam, be asked questions about their
general health, be askd specific questions about any problems that they might be having and
any medications they may be taking.
Participants will also undergo blood tests, have tumor markers drawn, be asked to complete
health-realted questionnaires, and undergo body scans to assess the effects of ruxolitinib
on your tumor(s).
Partipant's medical condition will be followed for up to 2 years following study completion.
This will happen through medical record reviews as well as phone calls to the participant or
partipants' doctor.
Inclusion Criteria:
- Histologically or cytologically confirmed invasive breast cancer
- Must have known ER, PR and HER2 status
- Either, Triple Negative Metastatic Breast Cancer or
- Inflammatory Breast Cancer with any ER, PR HER2 status
- Availability of archival tissue specimen suitable for pStat3 testing
- Life expectancy of greater than 3 months
- Measurable disease by RECIST
- At least one prior chemotherapy regimen for treatment of metastatic breast cancer
and/or recurrence within 12 months of completion of neoadjuvant/adjuvant chemotherapy
or
- For patients with inflammatory breast cancer but no distant metastases, progression
through standard neoadjuvant chemotherapy is required
Exclusion Criteria:
- Pregnant or breastfeeding
- Active brain metastases
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to ruxolitinib
- Clinically significant malabsorption syndrome
- Concurrent use of medications/substances that are strong inhibitors of CY3A4
- No uncontrolled intercurrent illness
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