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A Phase II, Multicenter, Single-Arm, Feasibility Study of Eribulin in Combination With Capecitabine for Adjuvant Treatment in Estrogen Receptor-Positive Early Stage Breast Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Estrogen Receptor Positive Tumor, Breast Cancer

Thank you

Trial Information

A Phase II, Multicenter, Single-Arm, Feasibility Study of Eribulin in Combination With Capecitabine for Adjuvant Treatment in Estrogen Receptor-Positive Early Stage Breast Cancer


Inclusion Criteria:



1. Male subjects aged ≥ 18 years and female subjects who must be postmenopausal (at
least 12 months consecutive amenorrheic or have had a bilateral oophorectomy or, if
they have had a hysterectomy but with ovaries intact, then females must be age 55 or
older and with postmenopausal follicle-stimulating hormone [FSH] levels).

2. 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.

3. Histologically confirmed Stage I to II invasive breast cancer. Subjects may have more
than one synchronous primary breast tumor.

4. Receptor Status:

- HER2-normal as determined by a negative fluorescence in situ hybridization
(FISH) result or 0 to 1+ by immunohistochemistry (IHC) staining result

- ER-positive, node-negative or ER-positive Grade 1 or 2 node-positive breast
cancer

5. ECOG performance status of 0 or 1

6. Adequate renal function as evidenced by serum creatinine ≤ 1.5 mg/dL or calculated
creatinine clearance ≥ 50 mL/min per the Cockcroft and Gault formula

7. 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

8. Adequate liver function as evidenced by bilirubin ≤ 1.5 times the upper limits of
normal (ULN) and alkaline phosphatase, alanine aminotransferase (ALT), and aspartate
aminotransferase (AST) ≤ 3 x ULN

9. Male subjects must have had a successful vasectomy (confirmed azoospermia), or their
female partners must not be of childbearing potential, or male subjects must agree to
use and have their female partners use a highly effective method of contraception
(e.g., total abstinence, an intrauterine device, a double-barrier method [such as
condom plus diaphragm with spermicide] throughout the entire study period and for 30
days after study drug discontinuation..

10. Voluntary agreement to provide written informed consent and willingness and ability
to comply with all aspects of the protocol

Exclusion Criteria:

1. Stage III and IV invasive breast cancer

2. Prior chemotherapy, radiation therapy, immunotherapy or biotherapy for current breast
cancer

3. Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc) that would
preclude any of the study therapy drugs

4. Subjects with a concurrently active second malignancy other than adequately treated
nonmelanoma skin cancers or in situ cervical cancer

5. Subjects with pre-existing neuropathy > Grade 2

6. Subjects with known positive human immunodeficiency virus (HIV) status

7. Females of childbearing potential. Females will be considered to be of childbearing
potential unless they are postmenopausal (at least 12 months consecutive amenorrheic
or have had a bilateral oophorectomy or, if they have had a hysterectomy but with
ovaries intact, then females must be age 55 or older and with postmenopausal FSH
levels).

8. Subjects with current gastrointestinal disease or other condition resulting in an
inability to take or absorb oral medications

9. Subjects with known allergy or hypersensitivity to eribulin mesylate or its
excipients, or to fluoropyrimidine therapy (with or without documented
dihydropyrimidine dehydrogenase [DPD] deficiency)

10. A clinically significant electrocardiogram (ECG) abnormality, including a marked
baseline prolongation of QT/QTc interval (time between the start of the Q wave and
the end of the T wave / QT interval corrected for heart rate) (e.g., repeated
demonstration of a QTc interval > 500 ms)

11. Any medical or other condition which, in the opinion of the investigator, would
preclude participation in a clinical trial

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 evaluate the feasibility of adjuvant treatment eribulin plus capecitabine for each individual subject the regimen is considered feasible if that subject is able to achieve relative dose intensity (RDI) of at least 85% of the 4 cycles of treatment.

Outcome Description:

Relative dose intensity for each subject will be calculated as follows: (1) based on each subject's body surface area (BSA), a total planned dose for both eribulin (Dep) and capecitabine (Dcp) calculated for a full 4-cycle regimen; (2) actual total dose of eribulin (Dea) and capecitabine (Dca) for the full 4-cycle regimen as collected on the case report form; (3) overall RDI = (Dea/Dep + Dca/Dcp)/2.

Outcome Time Frame:

12 wks

Safety Issue:

No

Principal Investigator

David Cox

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Inc.

Authority:

United States: Food and Drug Administration

Study ID:

E7389-A001-212

NCT ID:

NCT01439282

Start Date:

August 2011

Completion Date:

Related Keywords:

  • Estrogen Receptor Positive Tumor
  • Breast Cancer
  • Estrogen Receptor-Positive Early Stage Breast Cancer
  • Breast Neoplasms

Name

Location

Virginia Oncology AssociatesNewport News, Virginia  23606
Cancer Centers of the CarolinasGreenville, South Carolina  29605
New York Oncology Hematology, P.C.Albany, New York  12208
Cancer Centers of FloridaOrlando, Florida  32806
Northwest Georgia Oncology Centers, P.C.Marietta, Georgia  30060
Northwest Cancer Specialists, P.C.Vancouver, Washington  
Cancer Care Centers of South TexasSan Antonio, Texas  78229
Yakima Valley Memorial Hospital/North Star LodgeYakima, Washington  98902
Evergreen Hematology & OncologySpokane, Washington  99218
Texas Oncology-Austin CentralAustin, Texas  78731
Texas Oncology-TylerTyler, Texas  75702
Arizona Oncology Associates, PC - HOPETucson, Arizona  85704
Texas Oncology-Methodist Charlton Cancer CenterDallas, Texas  75237
Texas Oncology-Dallas Presbyterian HospitalDallas, Texas  75231
Texas Oncology- Denton SouthDenton, Texas  76210
Texas Oncology-Memorial CityHouston, Texas  77024
Texas Oncology-Baylor Charles A. Sammons Cancer CenterDallas, Texas  75246
Texas Oncology-Medical City DallasDallas, Texas  75230-2510
Arizona Oncology Associates, PC - CASATucson, Arizona  85715
Sciode Medical Associates, PLLC, d.b.a. Eastchester CenterBronx, New York  10469
Texas Oncology-Fort Worth 12th Ave.Fort Worth, Texas  ??76104
Texas Oncology-LewisvilleLewisville, Texas  ??75067
Texas Oncology-ParisParis, Texas  75460