The main objective of this trial is to determine patient response to eribulin (Halaven) followed by doxorubicin (Adriamycin) and cyclophosphamide (Cytoxan) treatment. The main outcome to be measured is number of patients who experience a complete response to treatment (disappearance of signs of cancer). This trial is being conducted in Boston, Massachusetts (USA).
The details
Chemotherapy is a treatment often used in breast cancer. Doxorubicin and cyclophosphamide are common chemotherapy drugs used in cancer. Eribulin is currently being studied as potential breast cancer targeted treatment prior to receiving the above chemotherapy drugs. Eribulin targets cancer cell growth and prevents cancer spread.
The main aim of this trial is to evaluate the response to eribulin in patients with inflammatory breast cancer before receiving chemotherapy treatment. The outcomes measured will include disappearance of signs of cancer and time to disease progression.
Who are they looking for?
This trial will recruit 25 patients with invasive breast cancer who are capable of functioning on a physical, social and mental level will be considered for this trial. Patients must have evidence of inflammatory breast cancer and not show signs or symptoms of bone tumors. Women of child-bearing potential and men must agree to use contraception for the duration of the trial as the effect on pregnancy is unknown. Patients must have normal organ function.
Patients who have recurring or additional severe illnesses (for example, brain tumors, heart complications, HIV positive) will not be eligible for this trial. However, patients will be considered eligible in circumstances where they have been disease-free for at least 3 years and are considered low risk for recurrence of the illness. Patients applying must not have received previous treatment with doxorubicin, cyclophosphamide or paclitaxel (Taxol).
How will it work
Patients will receive eribulin by IV (into a vein) for 4 cycles, followed by 4 cycles of doxorubicin and cyclophosphamide.
Patients will also undergo two breast biopsies, surgical removal of the breasts (mastectomy), radiation therapy, and hormonal therapy (if cancer is dependent on hormones such as estrogen or progesterone for growth).
