Clinical trial NCT01368107 (phase 2, status: completed)
Conditions: metastatic breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: placebo, interleukin 7, interleukin 7, interleukin 7
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Female aged more than 18 years

          -  Histologic diagnosis of metastatic breast cancer to be treated with capecitabine at
             study entry. NB: Patients previously treated with capecitabine are eligible only if
             more than 6 months have elapsed since the last capecitabine intake.

          -  Lymphopenic (i.e. with at least one value of lymphocyte count 1500/µL within 15 days
             before Day 0).

          -  Performance status ECOG of 0, 1,2 or 3

          -  Life expectancy ≥ 6months

          -  Adequate bone marrow, hepatic and renal function as follows:

               -  Neutrophils ≥ 1,000/µL

               -  Platelets ≥ 100 109/µL

               -  ASAT, ALAT, or Alkaline Phosphatase ≤ 2.5 x ULN

               -  Total Bilirubin ≤ 1.5 x ULN

               -  INR ≤ 1.5

               -  Calculated creatinin clearance ≥ 60mL/min (Cockcroft formula or MDRD formula for
                  patients older than 65 years old)- Ability to understand and sign informed
                  consent

          -  Covered by a medical insurance.

        Exclusion Criteria:

          -  Prior history of other malignancies other than breast cancer (except for basal cell or
             squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the
             subjects has been free of the disease for at least 3 years.

          -  No resolution of specific toxicities related to any prior anti-cancer therapy to Grade
             ≤2 according to the NCI CTCAE v.4.0 (except lymphopenia, alopecia and neuropathy)

          -  Wash out period of less than 5 times the half-life of previous anti-cancer treatment
             before study entry, except if previous chemotherapy treatment before study entry. NB:
             For patient previously treated by hormonotherapy, a wash out period of 1 week will be
             sufficient

          -  Uncontrolled hypertension (i.e., resting systolic blood pressure greater than140 mmHg
             or resting diastolic blood pressure greater than 90 mmHg), despite pharmacologic
             antihypertensive treatment, confirmed with a second blood pressure measurement done
             later in the same day

          -  History of lymphoid malignancy (e.g. Hodgkin disease, non Hodgkin lymphoma, Leukemia).

          -  History of splenectomy or hematologic disease associated with hypersplenism, such as
             gamma or beta-thalassemia, hereditary spherocytosis, Gaucher's disease, or autoimmune
             hemolytic anemia.

          -  Any cardiac, pulmonary, thyroid, renal, hepatic, neurological severe/uncontrolled
             concurrent medical disease that in the opinion of the investigator could cause
             unacceptable safety risks or compromise compliance with the protocol

          -  Any history of severe auto-immune disease

          -  Hepatitis B antigen (HBs Ag) positive, Hepatitis C (HCV Ab) antibody positive or HCV
             RNA detectable

          -  Documented HIV-1 positivity

          -  History of cardiovascular disorders grade >2 (NYHA) within 6 months preceding the
             inclusion

          -  Active uncontrolled viral, fungal or bacterial infection

          -  Active drug or alcohol use or dependence that, in the opinion of the investigator,
             would interfere with adherence to study requirements (participants must agree to
             refrain from substance abuse use during the entire course of the study)

          -  Pregnant or breast-feeding women

          -  No use of effective birth control methods for women of childbearing potential

          -  Any contraindications to capecitabine treatment (refer to Xeloda SPC Appendix 11) and
             to any other anti-cancer treatment authorized as per protocol (refer to respective SPC
             for specific contraindications)