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

NCT01439282 | Completed Phase 2 Results

• 1 other identifier: E7389-A001-212
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 23

Brief Summary

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.

Conditions

Estrogen Receptor Positive Tumor; Breast Cancer

Keywords

Estrogen Receptor-Positive Early Stage Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved the Target Relative Dose Intensity (RDI) of 85%

  Relative Dose Intensity (RDI) is defined as the amount of drug administered over a specific time and is expressed as the fraction of that recommended for standard of care. The RDI for each participant was calculated as follows: (1) based on each participant'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. For each individual participant, the regimen was considered feasible if that participant was able to achieve an RDI of at least 85% of the 4 cycles of eribulin plus capecitabine treatment. Missing doses due to any reason was counted as zero in the RDI calculation.

  21-Day Cycle 1 through 21-Day Cycle 4

Secondary Outcomes (2)

• Use of Cold Cap for Alopecia

  On the day of study drug infusion treatments during Cycles 1 through 4

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Day 1 through 30 days after last dose of study drugs (approximately up to 3 years)

Study Arms (1)

Eribulin + Capecitabine

EXPERIMENTAL

Drug: eribulin mesylate; Drug: capecitabine

Interventions

eribulin mesylate DRUG

Cohort I \& II: eribulin mesylate (E7389) 1.4 mg/m2 intravenously over 2 - 5 minutes on Day 1 and Day 8 for 4 cycles

Also known as: BOLD, Halaven, E7389

Eribulin + Capecitabine

capecitabine DRUG

Cohort 1: capecitabine 900 mg/m2 orally twice daily on Days 1 - 14 of a 21-day cycle for 4 cycles Cohort II: fixed dose of 1500 mg oral capecitabine twice daily, 7 days on then 7 days off for 4 cycles

Also known as: Xeloda

Eribulin + Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male subjects aged greater than or equal to 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).
• 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.
• Histologically confirmed Stage I to II invasive breast cancer. Subjects may have more than one synchronous primary breast tumor.
• 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
• 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 greater than or equal to 50 mL/min per the Cockcroft and Gault formula
• Adequate bone marrow function as evidenced by ANC greater than or equal to 1.5 x 10\^9/L, hemoglobin greater than or equal to 10.0 g/dL, and platelet count greater than or equal to 100 x 10\^9/L
• Adequate liver function as evidenced by bilirubin less than or equal to 1.5 times the upper limits of normal (ULN) and alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 x ULN
• 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..
• Voluntary agreement to provide written informed consent and willingness and ability to comply with all aspects of the protocol

You may not qualify if:

• Stage III and IV invasive 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 pre-existing neuropathy greater than Grade 2
• Subjects with known positive human immunodeficiency virus (HIV) status
• 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).
• Subjects with current gastrointestinal disease or other condition resulting in an inability to take or absorb oral medications
• Subjects with known allergy or hypersensitivity to eribulin mesylate or its excipients, or to fluoropyrimidine therapy (with or without documented dihydropyrimidine dehydrogenase \[DPD\] deficiency)
• 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 greater than 500 ms)
• Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (23)

Arizona Oncology Associates, PC - HOPE

Tucson, Arizona, 85704, United States

Location

Arizona Oncology Associates, PC - CASA

Tucson, Arizona, 85715, United States

Location

Cancer Centers of Florida

Orlando, Florida, 32806, United States

Location

Northwest Georgia Oncology Centers, P.C.

Marietta, Georgia, 30060, United States

Location

New York Oncology Hematology, P.C.

Albany, New York, 12206, United States

Location

Sciode Medical Associates, PLLC, d.b.a. Eastchester Center

The Bronx, New York, 10469, United States

Location

Cancer Centers of the Carolinas

Greenville, South Carolina, 29605, United States

Location

Texas Oncology-Austin Central

Austin, Texas, 78731, United States

Location

Texas Oncology-Medical City Dallas

Dallas, Texas, 75230, United States

Location

Texas Oncology-Dallas Presbyterian Hospital

Dallas, Texas, 75231, United States

Location

Texas Oncology-Methodist Charlton Cancer Center

Dallas, Texas, 75237, United States

Location

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Texas Oncology- Denton South

Denton, Texas, 76210, United States

Location

Texas Oncology-Fort Worth 12th Ave.

Fort Worth, Texas, 76104, United States

Location

Texas Oncology-Memorial City

Houston, Texas, 77024, United States

Location

Texas Oncology-Lewisville

Lewisville, Texas, 75067, United States

Location

Texas Oncology-Paris

Paris, Texas, 75460, United States

Location

Cancer Care Centers of South Texas

San Antonio, Texas, 78217, United States

Location

Texas Oncology-Tyler

Tyler, Texas, 75702, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Evergreen Hematology and Oncology

Spokane, Washington, 99218, United States

Location

Northwest Cancer Specialists, P.C.

Vancouver, Washington, 98684, United States

Location

Yakima Valley Memorial Hospital/North Star Lodge

Yakima, Washington, 98902, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

eribulin; Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Eisai Medical Information
• Organization: Eisai Inc.

esi_oncmedinfo@eisai.com

1-888-274-2378

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2011
• First Posted: September 23, 2011
• Study Start: August 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: May 1, 2014
• Last Updated: June 22, 2023
• Results First Posted: June 20, 2016

Record last verified: 2016-05

Locations

US (23)