Study Of Ruxolitinib (INCB018424) With Preoperative Chemotherapy For Triple Negative Inflammatory Breast Cancer

Conditions

• Inflammatory Breast Cancer (IBC)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.
• 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.

Study Details

This research study is studying Ruxolitinib as possible treatment for Inflammatory Breast Cancer (IBC). The Following drugs will be use in combination with Ruxolinitinib. * Paclitaxel (also called Taxol) * Doxorubicin also called Adriamycin * Cyclophosphamide, also called Cytoxan

Key Dates

Start date

Jan 24, 2018

Status verified

Jan 2026

Primary completion

Dec 31, 2022

Completion

Apr 30, 2026

Study Design

Enrollment

23 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Paclitaxel (12weeks)
  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
• Experimental: Ruxolitinib with Paclitaxel (12weeks)
  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
• Experimental: Ruxolitinib and Paclitaxel (12weeks)
  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

Primary Outcome Measure

Biologic Response To 7-Day Run-In Window Phase Treatment of Ruxolitinib Alone or Ruxolitinib Plus Paclitaxel [ Time Frame: 7 days ]

Locations (4)

Find similar trials in Boston, MA