Dose Dense Doxorubucin and Cyclophosphamide Followed by Eribulin Mesylate for the Adjuvant Treatment of Early Stage Breast Cancer
Condition: HER2-normal
MeSH terms: Breast Neoplasms
Intervention: eribulin mesylate
Intervention description: Dose dense doxorubicin and cyclophosphamide for 4 cycles during the first 8 weeks followed by eribulin mesylate 1.4mg/m2 for 4 cycles during the next 12 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Breast Cancer; HER2-normal Stage I to III invasive breast cancer

Summary:

      The purpose of this study is to assess the feasibility of dose-dense doxorubicin and
      cyclophosphamide followed by eribulin mesylate for adjuvant treatment of early stage breast
      cancer.
    

Eligibility criteria:

        Inclusion Criteria

          -  Male and female subjects aged greater than or equal to (>=) 18 years

          -  Histologically confirmed Stage I to III invasive breast cancer. Subjects may have more
             than one synchronous primary breast tumor.

          -  HER-2 normal as determined by fluorescence in situ hybridization (FISH) or 0 or 1+ by
             immunohistochemistry (IHC) staining.

          -  Subject is a candidate for chemotherapy in the adjuvant setting. Adjuvant therapy must
             begin within 84 days of the final surgical procedure for breast cancer.

          -  Adequate cardiac function, defined by baseline LVEF >=50 percent (%) by Multiple Gated
             Acquisition (MUGA) scan or echocardiogram.

          -  ECOG performance status of 0 or 1.

          -  Adequate renal function as evidenced by serum creatinine less than or equal to (<=)
             1.5 mg/dL or calculated creatinine clearance >=40 mL/min per the Cockcroft and Gault
             formula.

          -  Adequate bone marrow function as evidenced by ANC >=1.5 x 10^9/L, hemoglobin >=10.0
             g/dL, and platelet count >=100 x 10^9/L.

          -  Adequate liver function as evidenced by bilirubin <=1.5 times the upper limits of
             normal (ULN) and alkaline phosphatase (AP), alanine aminotransferase (ALT), and
             aspartate aminotransferase (AST) <=3 x ULN.

          -  Females of childbearing potential must have a negative urine or beta-human chorionic
             gonadotropin serum pregnancy test within 2 weeks prior to Cycle 1, Day 1. A urine
             pregnancy test should be repeated prior to chemotherapy if not conducted within 72
             hours of start of treatment. Female subjects of childbearing potential must agree to
             be abstinent or to use a highly effective method of contraception (e.g., condom +
             spermicide, condom + diaphragm with spermicide, intrauterine device (IUD), or have a
             vasectomized partner) having started for at least one menstrual cycle prior to
             starting study drug and throughout the entire study period and for 30 days (longer if
             appropriate) after the last dose of study drug. Perimenopausal women must be
             amenorrheic for at least 12 months to be considered of nonchildbearing potential. Male
             subjects who are not abstinent or who have undergone a successful vasectomy, who are
             partners of women of childbearing potential must use, or their partners must use, a
             highly effective method of contraception (e.g., condom + spermicide, condom +
             diaphragm with spermicide, IUD) starting for at least one menstrual cycle prior to
             starting study drug and throughout the entire study period and for 30 days (longer if
             appropriate) after the last dose of study drug. Subjects with partners using hormonal
             contraceptives must also be using an additional approved method of contraception (as
             described previously).

          -  Subjects willing and able to comply with the study protocol for the duration of the
             study and provide written informed consent prior to any study-specific screening
             procedures with the understanding that the subject may withdraw consent at any time
             without prejudice.

        Exclusion Criteria

          -  Stage IV breast cancer.

          -  Prior chemotherapy, radiation therapy, immunotherapy, or biotherapy for current breast
             cancer.

          -  Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would
             preclude any of the study therapy drugs.

          -  Subjects with a concurrently active second malignancy other than adequately treated
             nonmelanoma skin cancers or in situ cervical cancer.

          -  Subjects with known positive human immunodeficiency virus (HIV) status.

          -  Pregnancy or breast feeding at the time of study enrollment. Eligible subjects of
             reproductive potential (both sexes) must agree to use adequate contraceptive methods
             during study therapy.

          -  Subjects with known allergy or hypersensitivity to doxorubicin, cyclophosphamide, or
             eribulin mesylate.

          -  Inability to comply with the study and/or follow-up procedures.