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Clinical Trials/NCT02623972
NCT02623972
Active, not recruiting
Phase 2

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

Dana-Farber Cancer Institute2 sites in 1 country22 target enrollmentStarted: February 26, 2016Last updated:
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ConditionsInflammatory Breast CancerHuman Epidermal Growth Factor 2 Negative Carcinoma of Breast
InterventionsEribulinAdriamycinCyclophosphamide
DrugsEribulinAdriamycinCyclophosphamide

Overview

Phase
Phase 2
Status
Active, not recruiting
Enrollment
22
Locations
2
Primary Endpoint
Pathologic Complete Response Rate
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

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.

Arms & Interventions

Arm A: Eribulin > AC

Experimental
  • Eribulin-Administered via iv, at predetermined dosage and schedule per cycle
  • Two research breast biopsies
  • Adriamycin (doxorubicin) via iv a predetermined dosage and schedule per cycle
  • Cyclophosphamide (AC) via iv a predetermined dosage and schedule per cycle
  • Surgical Removal of the breasts (Mastectomy) and axillary lymph node dissection
  • Radiation Therapy
  • Endocrine Therapy (if applicable)
  • Optional 5 Patient-Optional DCE-MRI (Dynamic Contrast Enhanced-Magnetic Resonance Imaging) scans

Intervention: Eribulin (Drug)

Arm A: Eribulin > AC

Experimental
  • Eribulin-Administered via iv, at predetermined dosage and schedule per cycle
  • Two research breast biopsies
  • Adriamycin (doxorubicin) via iv a predetermined dosage and schedule per cycle
  • Cyclophosphamide (AC) via iv a predetermined dosage and schedule per cycle
  • Surgical Removal of the breasts (Mastectomy) and axillary lymph node dissection
  • Radiation Therapy
  • Endocrine Therapy (if applicable)
  • Optional 5 Patient-Optional DCE-MRI (Dynamic Contrast Enhanced-Magnetic Resonance Imaging) scans

Intervention: Adriamycin (Drug)

Arm A: Eribulin > AC

Experimental
  • Eribulin-Administered via iv, at predetermined dosage and schedule per cycle
  • Two research breast biopsies
  • Adriamycin (doxorubicin) via iv a predetermined dosage and schedule per cycle
  • Cyclophosphamide (AC) via iv a predetermined dosage and schedule per cycle
  • Surgical Removal of the breasts (Mastectomy) and axillary lymph node dissection
  • Radiation Therapy
  • Endocrine Therapy (if applicable)
  • Optional 5 Patient-Optional DCE-MRI (Dynamic Contrast Enhanced-Magnetic Resonance Imaging) scans

Intervention: Cyclophosphamide (Drug)

Arm B: AC > Eribulin

Experimental
  • Adriamycin (doxorubicin) via iv a predetermined dosage and schedule per cycle
  • Cyclophosphamide (AC) via iv a predetermined dosage and schedule per cycle
  • Two research breast biopsies
  • Eribulin-Administered via iv, at predetermined dosage and schedule per cycle
  • Surgical Removal of the breasts (Mastectomy) and axillary lymph node dissection
  • Radiation Therapy
  • Endocrine Therapy (if applicable)
  • Optional 5 Patient-Optional DCE-MRI (Dynamic Contrast Enhanced-Magnetic Resonance Imaging) scans

Intervention: Eribulin (Drug)

Arm B: AC > Eribulin

Experimental
  • Adriamycin (doxorubicin) via iv a predetermined dosage and schedule per cycle
  • Cyclophosphamide (AC) via iv a predetermined dosage and schedule per cycle
  • Two research breast biopsies
  • Eribulin-Administered via iv, at predetermined dosage and schedule per cycle
  • Surgical Removal of the breasts (Mastectomy) and axillary lymph node dissection
  • Radiation Therapy
  • Endocrine Therapy (if applicable)
  • Optional 5 Patient-Optional DCE-MRI (Dynamic Contrast Enhanced-Magnetic Resonance Imaging) scans

Intervention: Adriamycin (Drug)

Arm B: AC > Eribulin

Experimental
  • Adriamycin (doxorubicin) via iv a predetermined dosage and schedule per cycle
  • Cyclophosphamide (AC) via iv a predetermined dosage and schedule per cycle
  • Two research breast biopsies
  • Eribulin-Administered via iv, at predetermined dosage and schedule per cycle
  • Surgical Removal of the breasts (Mastectomy) and axillary lymph node dissection
  • Radiation Therapy
  • Endocrine Therapy (if applicable)
  • Optional 5 Patient-Optional DCE-MRI (Dynamic Contrast Enhanced-Magnetic Resonance Imaging) scans

Intervention: Cyclophosphamide (Drug)

Outcomes

Primary Outcomes

Pathologic Complete Response Rate

Time Frame: Assessed after preoperative therapy with either 4 cycles of eribulin mesylate (3 wks) followed by 4 cycles of doxorubicin/cyclophosphamide (2 wks) or after 4 cycles of AC(2 wks) followed by 4 cycles of eribulin(3 wks). As such up to 20 weeks.

Complete pathologic disease response (pCR) is defined as absence of invasive carcinoma within the breast and axillary lymph nodes following preoperative therapy, based upon pathological assessment of surgical specimens. Those with invasive carcinoma present within the breast and axillary lymph nodes, and participants whose disease is not surgically resectable following preoperative treatment are considered as not having pCR.

Secondary Outcomes

  • Residual Cancer Burden (RCB)(Assessed after preoperative therapy with either 4 cycles of eribulin mesylate (3 wks) followed by 4 cycles of doxorubicin/cyclophosphamide (2 wks) or after 4 cycles of AC(2 wks) followed by 4 cycles of eribulin(3 wks). As such summed up to 20 weeks.)
  • Time to Treatment Failure(TTF is assessed every cycle for 8 cycles. After protocol therapy, assessed every 3 months for 1 year, then every 6 months for 4 years, then annually until death. The TTF measurement duration is anticipated to last for at least 5 years.)
  • Overall Survival(OS is assessed every cycle for 8 cycles. After protocol therapy, assessed every 3 months for 1 year, then every 6 months for 4 years, then annually until death. The OS measurement duration is anticipated to last for at least 5 years.)
  • Disease Free Survival(DFS is assessed every cycle for 8 cycles. After protocol therapy, assessed every 3 months for 1 year, then every 6 months for 4 years, then annually until death.The DFS measurement duration is anticipated to last for at least 5 years.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Filipa Lynce, MD

Principal Investigator

Dana-Farber Cancer Institute

Study Sites (2)

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