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

  • STATUS
    Recruiting
  • End date
    Feb 24, 2024
  • participants needed
    64
  • sponsor
    Dana-Farber Cancer Institute
Updated on 24 January 2021
paclitaxel
cyclophosphamide
ruxolitinib
doxorubicin
metastasis
neutrophil count
immunohistochemistry
HER2
erbb2
invasive breast cancer
inflammatory breast cancer
cytoxan
mammogram
adriamycin

Summary

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

Description

This is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.

The FDA (U.S. Food and Drug Administration) has not approved Ruxolitinib for Inflammatory Breast Cancer (IBC), but is has been approved for other uses.

Ruxolitinib is a newly discovered drug that has been shown to block a pathway (called the IL6/JAK/Stat pathway) that may be important in cancer, including triple negative inflammatory breast cancer. Ruxolitinib brings proteins groups together, which can result in gene (DNA) changes. These DNA changes may stop cancer cells from growing.

Paclitaxel (also called Taxol), Doxorubicin and Cyclophosphamide (also called Adriamycin and Cytoxan, ("AC")) are drugs FDA approved for breast cancer patients. They have been shown to result in death of cancer cells when given as preoperative treatment of women with inflammatory breast cancer (IBC). Laboratory studies have shown that Ruxolitinib may make Paclitaxel more effective.

In this research study, the investigators are evaluating Ruxolitinib in combination with Paclitaxel followed by the standard chemotherapy, AC. Researchers will also evaluate how the IL6/JAK/Stat pathway is affected by this combination of drugs by studying biopsies and surgical specimens.

Details
Condition Breast Cancer, Inflammatory Breast Cancer, inflammatory breast cancers
Treatment cyclophosphamide, Paclitaxel, Ruxolitinib, doxorubicin
Clinical Study IdentifierNCT02876302
SponsorDana-Farber Cancer Institute
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Inflammatory Breast Cancer or Breast Cancer?
Do you have any of these conditions: inflammatory breast cancers or Inflammatory Breast Cancer or Breast Cancer?
Participants must have histologically confirmed invasive breast cancer. All histologic subtypes are eligible
Patients must have known ER, PR, and HER2 status defined as triple-negative breast cancer (TNBC), defined as
\--ER and PR <10% by immunohistochemistry, and HER2-negative ( as per ASCO/CAP
guidelines, defined as IHC 0 or 1+, or FISH ratio <2.0 or HER2 copy number
<6.0)
Patients must have the clinical diagnosis of inflammatory breast cancer, involving an intact breast
Age 18 years. Because no dosing or adverse event data are currently available on the use of ruxolitinib in participants <18 years of age, children are excluded from this study
ECOG performance status 0 or 1
Participants must have normal organ and marrow function as defined below
Leukocytes 3,000/mm3
Absolute neutrophil count 1,500/mm3
Platelets 100,000/mm3
Bilirubin 1.5 x institutional upper limit of normal (ULN)
AST (SGOT)/ALT (SGPT) < 2.5 X institutional upper limit of normal
Creatinine 1.5 x institutional upper limit of normal OR creatinine clearance > 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal
Patients with evidence of extensive nodal involvement are allowed. Extensive nodal involvement is defined as metastatic disease involving any nodal region outside of the involved breast
Patients with minimal metastatic disease involvement in bone or viscera are allowed. Minimal metastatic disease is defined as: evidence of metastatic involvement as demonstrated by imaging only, not amenable to biopsy confirmation
Both men and women are allowed
The effects of ruxolitinib on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry until completion of chemotherapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Ability to understand and the willingness to sign a written informed consent document
LVEF > 50% calculated by echocardiogram (ECHO) or MUGA
Patients may have bilateral breast cancer so long as one breast meets criteria for inflammatory breast cancer, and neither breast cancer has received prior therapy

Exclusion Criteria

Participants may not be receiving any other investigational agents
Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
History of allergic reactions attributed to compounds of similar chemical or biologic composition to ruxolitinib
Participants receiving any medications or substances that are potent inhibitors of CYP3A4, including grapefruit juice are ineligible. Participants receiving fluconazole are also ineligible. (Please refer to Appendix B for the full list of potent inhibitors and washout periods)
Chronic corticosteroid use in excess of the equivalent of prednisone 10 mg once daily
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study because paclitaxel, doxorubicin, and cyclophosphamide have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued if the mother is treated on study. These potential risks may also apply to other agents used in this study
Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
Known HIV-positive individuals on combination antiretroviral therapy are eligible so long as they meet all other criteria. Known HIV-positive individuals who are not on combination antiretroviral therapy are not eligible because these individuals are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated
Clinically significant malabsorption syndrome
Patients may not have received paclitaxel, doxorubicin, or cyclophosphamide as anti-neoplastic therapy
Patients with prior radiation to the affected breast
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