Ruxolitinib + Chemotherapy for Breast Cancer

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen byFilipa Lynce, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called Ruxolitinib combined with three other cancer drugs to treat Inflammatory Breast Cancer (IBC). It targets patients who may not respond well to typical treatments. Ruxolitinib works by blocking a pathway that cancer cells need to grow and helps other drugs be more effective. Ruxolitinib has been beneficial in the treatment of myelofibrosis.

Eligibility Criteria

This trial is for adults over 18 with triple-negative inflammatory breast cancer, who haven't had prior therapy for any breast cancer. They must be in good health with normal organ and marrow function, can have minimal metastatic disease, and agree to use contraception. Excluded are those on certain drugs or with brain metastases, HIV not on antiretrovirals, previous reactions to similar compounds as ruxolitinib, or uncontrolled illnesses.

Inclusion Criteria

Age ≥ 18 years.

You are in good enough physical condition to carry out your normal activities or to walk and carry out light work.

Both men and women are allowed.

+10 more

Exclusion Criteria

Participants may not be receiving any other investigational agents.

Participants with known brain metastases should be excluded from this clinical trial.

You have had allergic reactions to drugs similar to ruxolitinib.

+9 more

Participant Groups

The study tests Ruxolitinib combined with chemotherapy drugs Paclitaxel (Taxol), Doxorubicin (Adriamycin), and Cyclophosphamide (Cytoxan) as a treatment for Inflammatory Breast Cancer. It aims to see if this combination is effective before surgery in patients diagnosed with this aggressive form of breast cancer.

3Treatment groups

Experimental Treatment

Group I: Ruxolitinib with Paclitaxel (12weeks)Experimental Treatment4 Interventions

Paclitaxel is administered with daily Ruxolitinib, followed by standard Doxorubicin and Cyclophosphamide (AC) given every 2 weeks for 4 cycles preoperatively * 16 patients will be randomized from the Run-In 7 days of Ruxolitinib * The drug will be administered at a pre-determine dosage

Group II: Ruxolitinib and Paclitaxel (12weeks)Experimental Treatment4 Interventions

Paclitaxel is administered with daily Ruxolitinib, followed by standard Doxorubicin and Cyclophosphamide (AC) given every 2 weeks for 4 cycles preoperatively * 32 patients will be randomized from the Run-In 7 days of Ruxolitinib + Paclitaxel * The drug will be administered at a pre-determine dosage

Group III: Paclitaxel (12weeks)Experimental Treatment4 Interventions

Paclitaxel is administered weekly followed by standard Doxorubicin and Dyclophosphamide (AC) given every 2 weeks for 4 cycles preoperatively * 16 patients will be randomized from the Run-In 7 days of Ruxolitinib * The drug will be administered at a pre-determine dosage

Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Cytoxan for: