Study of Ruxolitinib with Preoperative Chemotherapy for Triple Negative Inflammatory Breast Cancer

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT02876302

Provider View

This clinical trial is exploring the use of Ruxolitinib, combined with chemotherapy drugs, as a potential treatment for inflammatory breast cancer that is triple-negative.

Patient Parameters

Program Overview

This study is testing Ruxolitinib, a drug that may help treat inflammatory breast cancer (IBC), especially the triple-negative type. Ruxolitinib is being combined with chemotherapy drugs Paclitaxel (Taxol), Doxorubicin (Adriamycin), and Cyclophosphamide (Cytoxan) to see if this combination can effectively treat IBC. The study will also look at how these drugs affect certain pathways in the body that are involved in cancer growth.

Description

This is a Phase II clinical trial, which means it is testing the safety and effectiveness of a new treatment to see if it works for a specific disease. Ruxolitinib is not yet approved by the FDA for treating inflammatory breast cancer, but it is approved for other uses. This drug works by blocking a pathway in the body that may be important in cancer growth, potentially stopping cancer cells from growing.

In this study, Ruxolitinib will be given with Paclitaxel first, followed by standard chemotherapy with Doxorubicin and Cyclophosphamide. Researchers will study how this combination affects cancer cells and certain pathways in the body by examining tissue samples from biopsies and surgeries.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed invasive breast cancer, including all subtypes.
  • Must have triple-negative breast cancer, meaning specific hormone receptors are not present.
  • Must have a clinical diagnosis of inflammatory breast cancer in an intact breast.
  • Must be 18 years or older.
  • Must have a good performance status, meaning able to carry out daily activities.
  • Must have normal organ and bone marrow function based on specific blood tests.
  • Can have cancer that has spread to lymph nodes or minimal spread to bones or organs.
  • Both men and women can participate.
  • Must agree to use effective birth control during the study.
  • Must be able to understand and sign a consent form.
  • Must have a heart function above a certain level.
  • Can have cancer in both breasts if one meets the criteria for inflammatory breast cancer and neither has been treated before.

Exclusion Criteria

  • Cannot be taking other experimental drugs.
  • Cannot have known brain metastases due to poor prognosis.
  • Cannot have allergies to similar drugs as Ruxolitinib.
  • Cannot be taking certain medications that affect how Ruxolitinib works.
  • Cannot be using high doses of steroids.
  • Cannot have uncontrolled illnesses or conditions that would interfere with the study.
  • Pregnant or breastfeeding women cannot participate due to potential risks to the baby.
  • Cannot have had another cancer unless it was treated and disease-free for at least 3 years, except for certain skin or cervical cancers.
  • HIV-positive individuals on treatment can participate if they meet all other criteria.
  • Cannot have significant absorption issues.
  • Cannot have previously received the chemotherapy drugs used in this study.
  • Cannot have had radiation therapy to the affected breast.

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