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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
77
Cohort I \& II: eribulin mesylate (E7389) 1.4 mg/m2 intravenously over 2 - 5 minutes on Day 1 and Day 8 for 4 cycles
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
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States
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.
Time frame: 21-Day Cycle 1 through 21-Day Cycle 4
Use of Cold Cap for Alopecia
Alopecia (hair loss) is a potential side effect of some chemotherapy agents. Chemotherapeutic drugs are toxic and could potentially harm the hair follicles (wear hair grows from) resulting in the hair falling out. It can occur in small patches on various parts of the body or all over the body and is usually temporary when related to cancer treatment. Cold cap therapy is one form of therapy for alopecia involving hair loss from the scalp. Wearing a cap or head covering with cold packs before, during, or after chemotherapy may help prevent hair loss as the cold narrows the blood vessels in the skin on your head which may lead to less of the drug reaching the hair follicles. Alopecia was one of the most common adverse events (AEs) related to eribulin only.
Time frame: 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)
Time frame: Day 1 through 30 days after last dose of study drugs (approximately up to 3 years)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Arizona Oncology Associates, PC - CASA
Tucson, Arizona, United States
Cancer Centers of Florida
Orlando, Florida, United States
Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia, United States
New York Oncology Hematology, P.C.
Albany, New York, United States
Sciode Medical Associates, PLLC, d.b.a. Eastchester Center
The Bronx, New York, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
Texas Oncology-Austin Central
Austin, Texas, United States
Texas Oncology-Medical City Dallas
Dallas, Texas, United States
Texas Oncology-Dallas Presbyterian Hospital
Dallas, Texas, United States
...and 13 more locations