Eribulin in Combination With Capecitabine for Adjuvant Treatment in Estrogen Receptor-Positive Early Stage Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01439282
First received: September 19, 2011
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

This is a Phase 2, multicenter, single-arm, feasibility study evaluating eribulin in combination with capecitabine as an adjuvant chemotherapy regimen in approximately 65 subjects with early-stage (I-II), human epidermal growth factor receptor 2 (HER2)- normal, estrogen receptor (ER)-positive breast cancer.


Condition Intervention Phase
Estrogen Receptor Positive Tumor
Breast Cancer
Drug: E7389 (eribulin mesylate) and capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: 12 wks ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Number of patients with adverse events of 4 cycles of eribulin plus capecitabine in the adjuvant setting [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Safety will be assessed by the monitoring and recording of all AEs and serious adverse events (SAEs), regular monitoring of hematology and clinical chemistry, vital signs, ECGs, ECOG performance status, regular physician assessments, concomitant medications, medical histories, and physical examinations.


Estimated Enrollment: 67
Study Start Date: August 2011
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eribulin + Capecitabine Drug: E7389 (eribulin mesylate) and capecitabine
eribulin mesylate (E7389) and capecitabine Eribulin 1.4 mg/m2 intravenously over 2 - 5 minutes Day 1 and Day 8 plus capecitabine 900 mg/m2 orally BID Days 1 - 14 of a 21-day cycle for 4 cycles
Other Name: BOLD

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01439282

Locations
United States, Arizona
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States, 85704
Arizona Oncology Associates, PC - CASA
Tucson, Arizona, United States, ?85715
United States, Florida
Cancer Centers of Florida
Orlando, Florida, United States, 32806
United States, Georgia
Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia, United States, 30060
United States, New York
New York Oncology Hematology, P.C.
Albany, New York, United States, 12206
Sciode Medical Associates, PLLC, d.b.a. Eastchester Center
Bronx, New York, United States, 10469
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
United States, Texas
Texas Oncology-Austin Central
Austin, Texas, United States, 78731
Texas Oncology-Methodist Charlton Cancer Center
Dallas, Texas, United States, 75237
Texas Oncology-Dallas Presbyterian Hospital
Dallas, Texas, United States, 75231
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Texas Oncology-Medical City Dallas
Dallas, Texas, United States, 75230
Texas Oncology- Denton South
Denton, Texas, United States, 76210
Texas Oncology-Fort Worth 12th Ave.
Fort Worth, Texas, United States, ??76104
Texas Oncology-Memorial City
Houston, Texas, United States, ?77024
Texas Oncology-Lewisville
Lewisville, Texas, United States, ??75067
Texas Oncology-Paris
Paris, Texas, United States, 75460
Cancer Care Centers of South Texas
San Antonio, Texas, United States, 78217
Texas Oncology-Tyler
Tyler, Texas, United States, ?75702
United States, Virginia
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
United States, Washington
Evergreen Hematology & Oncology
Spokane, Washington, United States, 99218
Northwest Cancer Specialists, P.C.
Vancouver, Washington, United States, ?98684
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States, 98902
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: David Cox Eisai Inc.
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01439282     History of Changes
Other Study ID Numbers: E7389-A001-212
Study First Received: September 19, 2011
Last Updated: February 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Estrogen Receptor-Positive Early Stage Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estrogens
Capecitabine
Fluorouracil
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on October 19, 2014