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Краткое названиеA Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy
Полное названиеA Randomized, Open-label, Multicenter, Phase 3 Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy
СпонсорJohnson & Johnson Pharmaceutical Research & Development, L.L.C.
Industry
ИсточникJohnson & Johnson Pharmaceutical Research & Development, L.L.C.
Под контролемUnited States: Food and Drug Administration
Краткое описаниеThe purpose of this study is to assess the impact on tumor progression as evaluated by
progression-free survival (PFS) of epoetin alfa plus standard supportive care as compared
with standard supportive care alone (packed red blood cell (RBC) transfusions), for treating
anemia according to label guidance in patients with metastatic breast cancer receiving
standard chemotherapy.
СостояниеИдет набор
Дата началаMarch 2006
ФазаPhase 3
Подробное описаниеAnemia is a common complication of the treatment of metastatic breast cancer and is related
to the effects of chemotherapy and to chronic disease itself. This is a randomized,
open-label, multicenter, international study to further examine the safety of the study drug
used with standard supportive care (i.e., packed RBC transfusions) compared to standard
supportive care alone, when used to treat anemia associated with chemotherapy. This study
will be done in subjects with metastatic breast cancer who are being or will be treated with
first-line chemotherapy with standard dose schedules of taxane monotherapy, or a taxane plus
trastuzumab, or an anthracycline plus either a taxane or cyclophosphamide. The study
hypothesis is that epoetin alfa, when used as supportive anemia care, does not increase the
risk of tumor progression or death. The study treatment will be compared to the control
treatment by comparing progression-free survival, i.e., the number of months from the date a
patient is randomized into the trial to the date of the first documented disease progression
or death. In addition to their chemotherapy, half of the subjects will be assigned to
receive study drug (epoetin alfa) and half of the subjects will be assigned to standard
supportive care for anemia. Subjects treated with the study drug will receive standard
supportive care (packed RBC transfusions) plus 40,000 IU epoetin alfa given subcutaneously
once a week until 4 weeks after the last cycle of chemotherapy or until disease progression,
whichever comes first.The hypothesis is to test that epoetin alfa, when used as supportive
anemia care, is non-inferior to control (standard supportive care alone), as measured by
progression free survival (PFS). Patients treated with the study drug will receive standard
supportive care (packed red blood cells (RBC) transfusions) plus 40,000 IU epoetin alfa
given subcutaneously once a week until 4 weeks after the last cycle of chemotherapy or until
disease progression, whichever comes first. Dose adjustments (dose escalation, dose
reduction, dose interruption, and dose resumption) of epoetin alfa will be based on
hemoglobin (Hb) and confirm to prescribing information.
Вид исследованияAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Набор0
КритерииInclusion Criteria:

- Histologically confirmed (e.g., slide of tissue) breast cancer

- HER2/NEU positive or negative

- Clinical evidence of metastasis (e.g., biopsy) with at least 1 measurable metastatic
(M1) lesion prior to starting the current chemotherapy

- Received 1st and 2nd line chemotherapy

- Hemoglobin (Hb) <= 11g/dL at the time of randomization

- planned to receive at least 2 more cycles of chemotherapy

- Life expectancy > 6 months

- Eastern Cooperative Oncology Group score 0 or 1

- At least 18 years old using effective birth control or surgically sterile or
postmenopausal for 1 year

Exclusion Criteria:

- Active second cancer

- no recent history of clinically relevant thrombovascular event

- Current treatment with anticoagulants

- Brain metastasis or CNS involvement

- Anemia secondary to another cause

- Recent (within prior 1 months) use of an ESA

- Patient pregnant or breast feeding

- Progressive disease during adjuvant/neoadjuvant chemotherapy

- Rapidly progressive or life-threatening metastatic disease

- Concomitant endocrine therapy

- Patient in whom the only site of metastasis was local and was successfully treated
surgically.
ПолFemale
Минимальный возраст18 Years
Максимальный возрастN/A
УсловиеBreast Cancer
Применяемое лечение
Drugepoetin alfa + packed RBC transfusion
OtherStandard supportive care (packed RBC transfusion)
Контакты и расположение
Cherkassy
Dnepropetrovsk
Donetsk
Ivano-Francovsk
Kiev
Lviv
Odessa
Uzhgorod
Vinnitsa
Zaprorozhye
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