A Phase 2 Study of Eribulin Followed by AC as Preoperative Therapy for HER2-negative Inflammatory Breast Cancer

  • STATUS
    Recruiting
  • End date
    Feb 26, 2023
  • participants needed
    32
  • sponsor
    Dana-Farber Cancer Institute
Updated on 26 January 2021
cyclophosphamide
neoadjuvant therapy
probe
neutrophil count
HER2
erbb2
invasive breast cancer
inflammatory breast cancer
adriamycin

Summary

This research study is studying a drug called eribulin combined with standard treatment as a possible preoperative treatment for HER2 negative inflammatory breast cancer.

Description

This research study 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.

Eribulin works by interfering with cancer cell division, growth, and spread.

The goal of this research study is to evaluate inflammatory breast cancer's response to treatment with eribulin followed by AC chemotherapy (Cohort A) and also the response to treatment with AC followed by Eribulin (Cohort B) when given as a preoperative chemotherapy treatment for participants with HER2 negative inflammatory breast cancer.

Details
Condition Breast Cancer, Inflammatory Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, inflammatory breast cancers
Treatment cyclophosphamide, Eribulin, Adriamycin
Clinical Study IdentifierNCT02623972
SponsorDana-Farber Cancer Institute
Last Modified on26 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 or Human Epidermal Growth Factor 2 Negative Carcinoma of Breast?
Do you have any of these conditions: Breast Cancer or inflammatory breast cancers or Human Epidermal Growth Factor 2 Negative Carcinoma of Breast or Inflammatory Breast Cancer?
Participants must have histologically confirmed invasive breast cancer. All histologic subtypes are eligible
\-- Patients must NOT have HER2 positive status based on ASCO/CAP guidelines
defined as: IHC 3+ based on circumferential membrane staining that is
complete, intense and/or
FISH positive based on one of the three following criteria
Single-probe average HER2 copy number 6.0 signals/cell; OR Dual-probe
HER2/CEP17 ratio <2.0 with an average HER2 copy number 6.0 signals/cell; OR
Dual-probe HER2/CEP17 ratio 2.0
Age 18 years. Because no dosing or adverse event data are currently available on the use of eribulin in participants <18 years of age, children are excluded from this study
ECOG performance status 1 (Karnofsky 70%)
Participants must have normal organ and marrow function as defined below
leukocytes 3,000/mcL
absolute neutrophil count 1,500/mcL
platelets 100,000/mcL
total bilirubin within normal institutional limits
AST(SGOT)/ALT(SGPT) 2.5 institutional upper limit of normal creatinine 1.5 institutional upper limit of normal
\--- OR
creatinine clearance 60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal
Patients must have the clinical diagnosis of inflammatory breast cancer
Patients must be without evidence of visceral or bone involvement with metastatic cancer on physical exam or any diagnostic study. Extensive nodal involvement (distant or regional) is allowed
LVEF > 50% calculated by echocardiogram (ECHO)
Patients may have bilateral breast cancer so long as one breast meets criteria for inflammatory breast cancer, and the breast with inflammatory breast cancer has never received prior therapy
The effects of eribulin on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, 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 and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of chemotherapy administration
Ability to understand and the willingness to sign a written informed consent document
Both men and women of all races and ethnic groups are eligible for this trial. Because breast cancer predominantly affects females, it is anticipated that male enrollment will be < 5% of the overall study population

Exclusion Criteria

Participants who are receiving any other investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to eribulin or other agents used in study
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 eribulin is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with eribulin, breastfeeding should be discontinued if the mother is treated with eribulin. These potential risks may also apply to other agents used in this study
HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with eribulin. In addition, these participants 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
A baseline corrected QT interval of > 470 ms
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
Patients may not have received eribulin, paclitaxel, doxorubicin, or cyclophosphamide as anti-neoplastic therapy
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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