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A Phase II, Single-Arm, Feasibility Study of Dose Dense Doxorubicin and Cyclophosphamide (AC) Followed by Eribulin Mesylate for the Adjuvant Treatment of Early Stage Breast Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Her2normal

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Trial Information

A Phase II, Single-Arm, Feasibility Study of Dose Dense Doxorubicin and Cyclophosphamide (AC) Followed by Eribulin Mesylate for the Adjuvant Treatment of Early Stage Breast Cancer


This is a single-center, single-arm Phase II trial to assess the feasibility of dose-dense
adjuvant chemotherapy in subjects with early stage (I-III), HER-2 normal breast cancer. A
total of 80 adult subjects will be enrolled in order to have 73 subjects who start the
eribulin portion of the adjuvant study regimen. After completion of 4 cycles of AC, each
subject will begin 4 cycles of eribulin mesylate 1.4 mg/m2 intravenously over 2 to 5 minutes
on Days 1 and 8 of every 21 day cycle.

Inclusion Criteria


Inclusion Criteria

- Male and female subjects aged > 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% by Multiple Gated
Acquisition (MUGA) scan or echocardiogram.

- ECOG performance status of 0 or 1.

- Adequate renal function as evidenced by serum creatinine < 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 109/L, hemoglobin > 10.0
g/dL, and platelet count > 100 x 109/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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To measure the feasibility of the regimen for each individual subject. The regimen is considered feasible if the subject is able to complete the eribulin portion of the regimen without dose delay or reduction

Outcome Description:

Subjects will be followed for approximately 3 years after the last dose of the study treatment.Feasibility rates will be calculated with or without growth factor support.

Outcome Time Frame:

Treatment will be administered over approximately 20 weeks, i.e., dose-dense AC for 4 cycles during the first 8 weeks and eribulin mesylate for 4 cycles during the next 12 weeks.

Safety Issue:

No

Principal Investigator

Jessicca Rege, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Inc.

Authority:

United States: Food and Drug Administration

Study ID:

E7389-A001-210

NCT ID:

NCT01328249

Start Date:

March 2011

Completion Date:

Related Keywords:

  • Her2normal
  • Breast Cancer
  • HER2-normal Stage I to III invasive breast cancer
  • Breast Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021