Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 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
Brief Summary: The 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.


Options:
A: Inclusion 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.
B: Inclusion Criteria:

- Subjects completing the planned 16 weeks of treatment on the 20010103 Anemia of Cancer protocol

Exclusion Criteria:

* Subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy
* Subjects who have other diagnoses not related to the cancer which can cause anemia
* Known history of seizure disorder
* Cardiac condition: uncontrolled angina, congestive heart failure, known ejection fraction less than 40%, or uncontrolled cardiac arrhythmia
* Uncontrolled hypertension
* Clinically significant systemic infection or chronic inflammatory disease present at the time of enrollment
* Subject of reproductive potential who is not using adequate contraceptive precautions
* Concerns for subject's compliance with the protocol procedures
C: Inclusion Criteria:

MDS defined as

* RCMD, RA with or without ring sideroblasts
* RAEB 1, or CMML 1, if WBC \< 13 G /l according to the WHO classification
* with a low or int-1 IPSS score AND
* primary or secondary resistance to epoetin alpha/ beta (\> 60000 U/w) or darbepoetin (\> 250ug/w), administered for at least 12 weeks
* requirement of RBC transfusions \> 4 U in the previous 8 weeks
* Aged 18 years or more
* Adequate contraception, if relevant
* Negative pregnancy test if relevant
* Written Informed consent
* Ability to participate to a clinical trial and adhere to study procedures
* Health insurance

Exclusion Criteria:

* Therapy-related MDS (after chemo- or radiotherapy for a previous neoplasm or immune disorder)
* Patients with a planned allogeneic bone marrow transplantation
* Creatininemia \>1.5 upper normal value or estimated Ccr less than 30ml/mn
* ALAT and ASAT \>2.5 upper normal value
* Bilirubin \>2N, except unconjugated hyperbilirubinemia due to MDS-related dyserythropoiesis
* Heart failure NYHA \> II
* Known allergy to mannitol
* Other tumor, unstable for the last three years, except in situ uterine carcinoma or basal skin tumor
* ECOG \> 2
* Life expectancy less than 3 months
D: Inclusion Criteria:

* Patients with a confirmed new diagnosis of malignant solid tumor, Hodgkin's disease, Acute Lymphocytic Leukemia (ALL) or Non-Hodgkin's Lymphoma (NHL)
* scheduled to receive first myelosuppressive chemotherapy within 7 days of baseline or have received up to the second myelosuppressive chemotherapy within 60 days prior to study enrollment, and scheduled to receive chemotherapy over a minimum period of 12 weeks after study enrollment
* anemic according to age-based and gender-based criteria (hemoglobin level of \< 10.5 g/dL for boys and girls ages 5 to 12 years, \< 11.0 g/dL for girls older than 12 years, \< 12.0 g/dL for boys older than 12 years)
* have an indwelling central venous access device (e.g., subcutaneous port, external Hickman-Broviac-type catheter, or peripherally inserted central catheter) or existing peripheral intravenous catheter in place for chemotherapy administration
* both male or female patients who are reproductive potential and sexually active must be practicing an acceptable method of birth control throughout the entire study
* Parent/legal guardian must have read and signed the informed consent and patients must have provided assent, as appropriate according to state and IRB requirements

Exclusion Criteria:

* Diagnosis of myeloid leukemia or other myeloid malignancy (e.g., granulocytic sarcoma)
* diagnosis of Down's Syndrome, tumor of the central nervous system (CNS) or symptomatic metastatic CNS disease (for the solid tumor/Hodgkin's Disease stratum), or presence of symptomatic CNS disease at diagnosis (for the Acute Lymphocytic Leukemia/Non-Hodgkin's Lymphoma stratum)
* scheduled to receive cranial irradiation during the study period, or has received cranial irradiation within 30 days prior to study enrollment
* have an inherited form of anemia (hemoglobinopathy, thalassemia, red cell membrane defect, red cell enzyme deficiency) or a Coombs-positive hemolytic anemia
* elevated serum creatinine based upon age of study entry ( \> 0.8 mg/dL for children younger than 10 years, \> 1.1 mg/dL for children 10 - 15 years, \> 1.4 mg/dL for children older than 15 years)

Answer: A