Metastatic Breast CancerPhase 2NCT01368107

Study Evaluating Impact of IL-7 on CD4 Lymphopenia, Risks of Severe Haematological Toxicity and Tumor Progression in Metastatic Breast Cancer Patients

A Phase 2 study testing interleukin 7 in people with Metastatic Breast Cancer, run by Centre Leon Berard at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to evaluate the impact of an immunotherapy by IL-7 on CD4 lymphopenia, risks of severe haematological toxicity and tumor progression in metastatic breast cancer patients. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Metastatic Breast Cancer
What is being tested?: interleukin 7
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 3 sitesFrance
Study dates: Jun 2011to Jun 2014
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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:

Show all 13Show fewer

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.

Who cannot join

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.

Show all 16Show fewer

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)

Trial locations and contacts

3 sites in 1 country.

France3 sites

Centre Leon Berard
Lyon
Institut Curie
Paris, 75005
Institut Gustave Roussy
Villejuif

Other trials in France

About this study

Official title: A Randomised, Multicentric, Phase 2a Study Evaluating the Impact of an Immunotherapy by IL-7 on CD4 Lymphopenia, Risks of Severe Haematological Toxicity and Tumor Progression in Metastatic Breast Cancer Patients

The purpose of the study is to evaluate the impact of an immunotherapy by IL-7 on CD4 lymphopenia, risks of severe haematological toxicity and tumor progression in metastatic breast cancer patients.

The primary objective is to determine the optimal schedule to deliver CYT107 during chemotherapy based on restoration of CD4 count.

This study is a phase II, randomised, double-blind, placebo-controlled, single-centre.

24 patients will be included in the study.

Read the detailed description

A key secondary objective is to determine if CYT107 treatment enables to reduce the incidence of severe haematological toxicity (any type of haematological toxicity Grade ≥ 3) post-chemotherapy.

Other secondary objectives are to assess the impact of CYT107 treatment on the following parameters:

Overall incidence of side effects (any type any grade)
Progression-free survival (PFS)
Compliance to chemotherapy regimen (dose intensity, number of chemotherapy cycles).
CD4 lymphopenia over the study period

Exploratory biological markers

A series of biomarkers analyses will be performed to evaluate if CYT107 treatment will:

selectively stimulate the proliferation and activation of peripheral immune subsets (analysis of phenotype and activation status of peripheral immune e sub-populations)
selectively improve the functional response of T cells, DC subsets and NK cells.
is able to revert tolerogenic immune burden to increase specific anti-tumor response (measure of antigen specific CD8 response, measure of cytokine plasmatic levels)
enable to increase TCR diversity (analysis of combinatorial diversity).

Conditions: Metastatic Breast Cancer
Being tested: placebo, interleukin 7
Keywords: IL-7, metastatic breast cancer patients, lymphopenia
Medical subject headings: Breast Neoplasms, Lymphopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

placeboDrug
Placebo before the 1st (D0, D7, D14)and during the 3rd CT cycle (D57, D64, D71)
interleukin 7Drug
patients will receive an induction cycle of CYT107 (10µg/kg/week subcutaneously for 3 weeks) before the 1st CT cycle (D0, D7, D14) and the placebo during the 3rd CT cycle (D57, D64, D71)
interleukin 7Drug
patients will receive the placebo before the 1st CT cycle (D0, D7, D14) and a delayed treatment with CYT107 (10µg/kg/week subcutaneously for 3 weeks) during the 3rd CT cycle (D57, D64, D71)
interleukin 7Drug
patients will receive an induction cycle of CYT107 (10µg/kg/week subcutaneously for 3 weeks) before the 1st CT cycle (D0, D7, D14) and a maintenance cycle of IL-7 (10µg/kg/week subcutaneously for 3 weeks) during the 3rd CT cycle (D57, D64, D71)

Study groups in NCT01368107
Study group	Role	What they receive
Placebo Arm	Placebo comparator	the patients will receive Placebo before the 1st and during the 3rd CT cycle (N=6) Receives: Drug: placebo
CYT107 treatment before CT	Experimental	patients will receive an induction cycle of CYT107 (10µg/kg/week subcutaneously for 3 weeks) before the 1st CT cycle and the placebo during the 3rd CT cycle (N=6) Receives: Drug: placebo; Drug: interleukin 7
CYT107 treatment during CT	Experimental	patients will receive the placebo before the 1st CT cycle and a delayed treatment with CYT107 (10µg/kg/week subcutaneously for 3 weeks) during the 3rd CT cycle (N=6) Receives: Drug: interleukin 7
CYT107 treatment before and during CT	Experimental	patients will receive an induction cycle of CYT107 (10µg/kg/week subcutaneously for 3 weeks) before the 1st CT cycle and a maintenance cycle of IL-7 (10µg/kg/week subcutaneously for 3 weeks) during the 3rd CT cycle (N=6). Receives: Drug: interleukin 7

What is being measured

The primary outcome is the main question the study is designed to answer.

to determine the optimal schedule to deliver CYT107 during chemotherapy based on restoration of CD4 count
Evolution of CD4 count from Day 0 to Week 11 with repeated measures from D0 to W12 (D0, D21, D57, D78).
Measured: after 11 weeks of treatment

Secondary outcomes (9)

to determine if CYT107 treatment enables to reduce the incidence of severe haematological toxicity (any type of haematological toxicity Grade ≥ 3) post-chemotherapy
Measured: at the end of study M12
To assess the impact of CYT107 on progression-free survival
Time from randomisation to first evidence of progression or death of any cause.
Measured: at the end of study (M12)
To assess the impact of CYT107 on compliance to chemotherapy regimen (dose intensity, number of chemotherapy cycles).
Number of CT cycles, CT dose delays and/or reduction, CT discontinuation
Measured: at the end of study (M12)
To assess the impact of CYT107 on CD4 lymphopenia over the study period
Evolution of CD4 count from Day 0 to end of study visit
Measured: at the end of study (M12)
to evaluate if CYT107 treatment will selectively stimulate the proliferation and activation of peripheral immune subsets (analysis of phenotype and activation status of peripheral immune e sub-populations)
Measure of frequency and activation status of circulating immune subpopulations on fresh whole blood. Multi-parametric marker sets (6-8 markers) will be used to analyse phenotype of immune subpopulations (TCD4+, TCD8+, Treg, T, NK, DC) and their activation status (PD1, ICOS, CD39, CD73, CD62L, CCR7, CD45RO, CD45RA, CD86).
Measured: D0, D21, D57, D78 and at end of study M12
to evaluate if CYT107 treatment will selectively improve the functional response of T cells, DC subsets and NK cells
Analysis of the functional response of T cells, DC subsets and NK cells
Measured: D0, D21, D57, D78 and at the end of study M12
to evaluate if CYT107 treatment will is able to revert tolerogenic immune burden to increase specific anti-tumor response (measure of antigen specific CD8 response, measure of cytokine plasmatic levels)
- Analysis of tumor associated antigen (TAA) specific CD8 responses
- Quantification of circulating cytokines including mainly, but not limited to, IL-6, IL-2, IFN, VEGF, TNF, IL-15,F FGF using Luminex technology and VEGF, TGF, IL-7R by Elisa.
Measured: D0, D21, D57, D78 and at the end of study M12
to evaluate if CYT107 treatment will enable to increase TCR diversity (analysis of combinatorial diversity).
Evaluation of T cell receptor diversity using ImmuneTraCkeR test and Constel'ID software (ImmunID Technologies, Grenoble, France).
Measured: D0, D21, D57, D78 and at the end of study M12
To assess the impact of CYT107 treatment on overall incidence of side effects
Number of patients with AEs (any type any grade) using NCI-CTCAE scale (version 4.0) from D0 to W12
Measured: after 12 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2011Jun 2014

First posted7 Jun 2011 (estimated)
Study startJun 2011
Primary completionSep 2013
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (30)Papers the sponsor has linked to this study.
Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01368107
Sponsor's protocol ID: ELYPSE 7
Other IDs: 2011-000226-30
Status last verified: Dec 2013
First submitted: 6 Jun 2011
Last updated: 9 Feb 2015
Results posted: No
Data monitoring committee: Yes

Publications

Zou W. Regulatory T cells, tumour immunity and immunotherapy. Nat Rev Immunol. 2006 Apr;6(4):295-307. doi: 10.1038/nri1806.
PubMed 16557261
Treilleux I, Blay JY, Bendriss-Vermare N, Ray-Coquard I, Bachelot T, Guastalla JP, Bremond A, Goddard S, Pin JJ, Barthelemy-Dubois C, Lebecque S. Dendritic cell infiltration and prognosis of early stage breast cancer. Clin Cancer Res. 2004 Nov 15;10(22):7466-74. doi: 10.1158/1078-0432.CCR-04-0684.
PubMed 15569976
Bates GJ, Fox SB, Han C, Leek RD, Garcia JF, Harris AL, Banham AH. Quantification of regulatory T cells enables the identification of high-risk breast cancer patients and those at risk of late relapse. J Clin Oncol. 2006 Dec 1;24(34):5373-80. doi: 10.1200/JCO.2006.05.9584.
PubMed 17135638
Gobert M, Treilleux I, Bendriss-Vermare N, Bachelot T, Goddard-Leon S, Arfi V, Biota C, Doffin AC, Durand I, Olive D, Perez S, Pasqual N, Faure C, Ray-Coquard I, Puisieux A, Caux C, Blay JY, Menetrier-Caux C. Regulatory T cells recruited through CCL22/CCR4 are selectively activated in lymphoid infiltrates surrounding primary breast tumors and lead to an adverse clinical outcome. Cancer Res. 2009 Mar 1;69(5):2000-9. doi: 10.1158/0008-5472.CAN-08-2360. Epub 2009 Feb 24.
PubMed 19244125
Blay JY, Chauvin F, Le Cesne A, Anglaret B, Bouhour D, Lasset C, Freyer G, Philip T, Biron P. Early lymphopenia after cytotoxic chemotherapy as a risk factor for febrile neutropenia. J Clin Oncol. 1996 Feb;14(2):636-43. doi: 10.1200/JCO.1996.14.2.636.
PubMed 8636781
Blay JY, Le Cesne A, Mermet C, Maugard C, Ravaud A, Chevreau C, Sebban C, Guastalla J, Biron P, Ray-Coquard I. A risk model for thrombocytopenia requiring platelet transfusion after cytotoxic chemotherapy. Blood. 1998 Jul 15;92(2):405-10.
PubMed 9657738
Ray-Coquard I, Le Cesne A, Rubio MT, Mermet J, Maugard C, Ravaud A, Chevreau C, Sebban C, Bachelot T, Biron P, Blay JY. Risk model for severe anemia requiring red blood cell transfusion after cytotoxic conventional chemotherapy regimens. The Elypse 1 Study Group. J Clin Oncol. 1999 Sep;17(9):2840-6. doi: 10.1200/JCO.1999.17.9.2840.
PubMed 10561360
Ray-Coquard I, Borg C, Bachelot T, Sebban C, Philip I, Clapisson G, Le Cesne A, Biron P, Chauvin F, Blay JY; ELYPSE study group. Baseline and early lymphopenia predict for the risk of febrile neutropenia after chemotherapy. Br J Cancer. 2003 Jan 27;88(2):181-6. doi: 10.1038/sj.bjc.6600724.
PubMed 12610500
Marec-Berard P, Blay JY, Schell M, Buclon M, Demaret C, Ray-Coquard I. Risk model predictive of severe anemia requiring RBC transfusion after chemotherapy in pediatric solid tumor patients. J Clin Oncol. 2003 Nov 15;21(22):4235-8. doi: 10.1200/JCO.2003.09.121.
PubMed 14615453
Borg C, Ray-Coquard I, Philip I, Clapisson G, Bendriss-Vermare N, Menetrier-Caux C, Sebban C, Biron P, Blay JY. CD4 lymphopenia as a risk factor for febrile neutropenia and early death after cytotoxic chemotherapy in adult patients with cancer. Cancer. 2004 Dec 1;101(11):2675-80. doi: 10.1002/cncr.20688.
PubMed 15503313
Ray-Coquard I, Cropet C, Van Glabbeke M, Sebban C, Le Cesne A, Judson I, Tredan O, Verweij J, Biron P, Labidi I, Guastalla JP, Bachelot T, Perol D, Chabaud S, Hogendoorn PC, Cassier P, Dufresne A, Blay JY; European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Lymphopenia as a prognostic factor for overall survival in advanced carcinomas, sarcomas, and lymphomas. Cancer Res. 2009 Jul 1;69(13):5383-91. doi: 10.1158/0008-5472.CAN-08-3845. Epub 2009 Jun 23.
PubMed 19549917
Fry TJ, Mackall CL. The many faces of IL-7: from lymphopoiesis to peripheral T cell maintenance. J Immunol. 2005 Jun 1;174(11):6571-6. doi: 10.4049/jimmunol.174.11.6571.
PubMed 15905493
Menetrier-Caux C, Gobert M, Caux C. Differences in tumor regulatory T-cell localization and activation status impact patient outcome. Cancer Res. 2009 Oct 15;69(20):7895-8. doi: 10.1158/0008-5472.CAN-09-1642. Epub 2009 Oct 6.
PubMed 19808962
Fry TJ, Moniuszko M, Creekmore S, Donohue SJ, Douek DC, Giardina S, Hecht TT, Hill BJ, Komschlies K, Tomaszewski J, Franchini G, Mackall CL. IL-7 therapy dramatically alters peripheral T-cell homeostasis in normal and SIV-infected nonhuman primates. Blood. 2003 Mar 15;101(6):2294-9. doi: 10.1182/blood-2002-07-2297. Epub 2002 Oct 31.
PubMed 12411295
Fry TJ, Mackall CL. Interleukin-7: from bench to clinic. Blood. 2002 Jun 1;99(11):3892-904. doi: 10.1182/blood.v99.11.3892. No abstract available.
PubMed 12010786

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Multicentric, Phase 2a Study Evaluating the Impact of an Immunotherapy by IL-7 on CD4 Lymphopenia, Risks of Severe Haematological Toxicity and Tumor Progression in Metastatic Breast Cancer Patients
ClinicalTrials.gov ID: NCT01368107
Acronym / sponsor ID: ELYPSE 7
Conditions: Metastatic Breast Cancer
Keywords: IL-7, metastatic breast cancer patients, lymphopenia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Centre Leon BerardUniversity, hospital or other
Collaborators: Ministry of Health, France, Cytheris, Inc.
Study start: Jun 2011
Primary completion: Sep 2013 (actual)
Study completion: Jun 2014 (actual)
First posted: 7 Jun 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the study is to evaluate the impact of an immunotherapy by IL-7 on CD4 lymphopenia, risks of severe haematological toxicity and tumor progression in metastatic breast cancer patients.

The primary objective is to determine the optimal schedule to deliver CYT107 during chemotherapy based on restoration of CD4 count.

This study is a phase II, randomised, double-blind, placebo-controlled, single-centre.

24 patients will be included in the study.

Detailed description

A key secondary objective is to determine if CYT107 treatment enables to reduce the incidence of severe haematological toxicity (any type of haematological toxicity Grade ≥ 3) post-chemotherapy.

Other secondary objectives are to assess the impact of CYT107 treatment on the following parameters:

Overall incidence of side effects (any type any grade)
Progression-free survival (PFS)
Compliance to chemotherapy regimen (dose intensity, number of chemotherapy cycles).
CD4 lymphopenia over the study period

Exploratory biological markers

A series of biomarkers analyses will be performed to evaluate if CYT107 treatment will:

selectively stimulate the proliferation and activation of peripheral immune subsets (analysis of phenotype and activation status of peripheral immune e sub-populations)
selectively improve the functional response of T cells, DC subsets and NK cells.
is able to revert tolerogenic immune burden to increase specific anti-tumor response (measure of antigen specific CD8 response, measure of cytokine plasmatic levels)
enable to increase TCR diversity (analysis of combinatorial diversity).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo Arm	Placebo comparator	Drug: placebothe patients will receive Placebo before the 1st and during the 3rd CT cycle (N=6)
CYT107 treatment before CT	Experimental	Drug: placebo, Drug: interleukin 7patients will receive an induction cycle of CYT107 (10µg/kg/week subcutaneously for 3 weeks) before the 1st CT cycle and the placebo during the 3rd CT cycle (N=6)
CYT107 treatment during CT	Experimental	Drug: interleukin 7patients will receive the placebo before the 1st CT cycle and a delayed treatment with CYT107 (10µg/kg/week subcutaneously for 3 weeks) during the 3rd CT cycle (N=6)
CYT107 treatment before and during CT	Experimental	Drug: interleukin 7patients will receive an induction cycle of CYT107 (10µg/kg/week subcutaneously for 3 weeks) before the 1st CT cycle and a maintenance cycle of IL-7 (10µg/kg/week subcutaneously for 3 weeks) during the 3rd CT cycle (N=6).

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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

Key exclusion criteria (16 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
placeboPlacebo before the 1st (D0, D7, D14)and during the 3rd CT cycle (D57, D64, D71)	Drug	CYT107 treatment before CT, Placebo Arm
interleukin 7patients will receive an induction cycle of CYT107 (10µg/kg/week subcutaneously for 3 weeks) before the 1st CT cycle (D0, D7, D14) and the placebo during the 3rd CT cycle (D57, D64, D71)	Drug	CYT107 treatment before CT
interleukin 7patients will receive the placebo before the 1st CT cycle (D0, D7, D14) and a delayed treatment with CYT107 (10µg/kg/week subcutaneously for 3 weeks) during the 3rd CT cycle (D57, D64, D71)	Drug	CYT107 treatment during CT
interleukin 7patients will receive an induction cycle of CYT107 (10µg/kg/week subcutaneously for 3 weeks) before the 1st CT cycle (D0, D7, D14) and a maintenance cycle of IL-7 (10µg/kg/week subcutaneously for 3 weeks) during the 3rd CT cycle (D57, D64, D71)	Drug	CYT107 treatment before and during CT

Primary outcome

to determine the optimal schedule to deliver CYT107 during chemotherapy based on restoration of CD4 count
Time frame: after 11 weeks of treatment
Evolution of CD4 count from Day 0 to Week 11 with repeated measures from D0 to W12 (D0, D21, D57, D78).

9 secondary outcomes

to determine if CYT107 treatment enables to reduce the incidence of severe haematological toxicity (any type of haematological toxicity Grade ≥ 3) post-chemotherapy
Time frame: at the end of study M12
To assess the impact of CYT107 on progression-free survival
Time frame: at the end of study (M12)
To assess the impact of CYT107 on compliance to chemotherapy regimen (dose intensity, number of chemotherapy cycles).
Time frame: at the end of study (M12)
To assess the impact of CYT107 on CD4 lymphopenia over the study period
Time frame: at the end of study (M12)
to evaluate if CYT107 treatment will selectively stimulate the proliferation and activation of peripheral immune subsets (analysis of phenotype and activation status of peripheral immune e sub-populations)
Time frame: D0, D21, D57, D78 and at end of study M12
to evaluate if CYT107 treatment will selectively improve the functional response of T cells, DC subsets and NK cells
Time frame: D0, D21, D57, D78 and at the end of study M12
to evaluate if CYT107 treatment will is able to revert tolerogenic immune burden to increase specific anti-tumor response (measure of antigen specific CD8 response, measure of cytokine plasmatic levels)
Time frame: D0, D21, D57, D78 and at the end of study M12
to evaluate if CYT107 treatment will enable to increase TCR diversity (analysis of combinatorial diversity).
Time frame: D0, D21, D57, D78 and at the end of study M12
To assess the impact of CYT107 treatment on overall incidence of side effects
Time frame: after 12 weeks of treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2015.
Results publication: PubMed 16557261Zou W. Regulatory T cells, tumour immunity and immunotherapy. Nat Rev Immunol. 2006 Apr;6(4):295-307. doi: 10.1038/nri1806.
Results publication: PubMed 15569976Treilleux I, Blay JY, Bendriss-Vermare N, Ray-Coquard I, Bachelot T, Guastalla JP, Bremond A, Goddard S, Pin JJ, Barthelemy-Dubois C, Lebecque S. Dendritic cell infiltration and prognosis of early stage breast cancer. Clin Cancer Res. 2004 Nov 15;10(22):7466-74. doi: 10.1158/1078-0432.CCR-04-0684.
Results publication: PubMed 17135638Bates GJ, Fox SB, Han C, Leek RD, Garcia JF, Harris AL, Banham AH. Quantification of regulatory T cells enables the identification of high-risk breast cancer patients and those at risk of late relapse. J Clin Oncol. 2006 Dec 1;24(34):5373-80. doi: 10.1200/JCO.2006.05.9584.
Results publication: PubMed 19244125Gobert M, Treilleux I, Bendriss-Vermare N, Bachelot T, Goddard-Leon S, Arfi V, Biota C, Doffin AC, Durand I, Olive D, Perez S, Pasqual N, Faure C, Ray-Coquard I, Puisieux A, Caux C, Blay JY, Menetrier-Caux C. Regulatory T cells recruited through CCL22/CCR4 are selectively activated in lymphoid infiltrates surrounding primary breast tumors and lead to an adverse clinical outcome. Cancer Res. 2009 Mar 1;69(5):2000-9. doi: 10.1158/0008-5472.CAN-08-2360. Epub 2009 Feb 24.
Results publication: PubMed 8636781Blay JY, Chauvin F, Le Cesne A, Anglaret B, Bouhour D, Lasset C, Freyer G, Philip T, Biron P. Early lymphopenia after cytotoxic chemotherapy as a risk factor for febrile neutropenia. J Clin Oncol. 1996 Feb;14(2):636-43. doi: 10.1200/JCO.1996.14.2.636.
Results publication: PubMed 9657738Blay JY, Le Cesne A, Mermet C, Maugard C, Ravaud A, Chevreau C, Sebban C, Guastalla J, Biron P, Ray-Coquard I. A risk model for thrombocytopenia requiring platelet transfusion after cytotoxic chemotherapy. Blood. 1998 Jul 15;92(2):405-10.
Results publication: PubMed 10561360Ray-Coquard I, Le Cesne A, Rubio MT, Mermet J, Maugard C, Ravaud A, Chevreau C, Sebban C, Bachelot T, Biron P, Blay JY. Risk model for severe anemia requiring red blood cell transfusion after cytotoxic conventional chemotherapy regimens. The Elypse 1 Study Group. J Clin Oncol. 1999 Sep;17(9):2840-6. doi: 10.1200/JCO.1999.17.9.2840.
Results publication: PubMed 12610500Ray-Coquard I, Borg C, Bachelot T, Sebban C, Philip I, Clapisson G, Le Cesne A, Biron P, Chauvin F, Blay JY; ELYPSE study group. Baseline and early lymphopenia predict for the risk of febrile neutropenia after chemotherapy. Br J Cancer. 2003 Jan 27;88(2):181-6. doi: 10.1038/sj.bjc.6600724.
Results publication: PubMed 14615453Marec-Berard P, Blay JY, Schell M, Buclon M, Demaret C, Ray-Coquard I. Risk model predictive of severe anemia requiring RBC transfusion after chemotherapy in pediatric solid tumor patients. J Clin Oncol. 2003 Nov 15;21(22):4235-8. doi: 10.1200/JCO.2003.09.121.
Results publication: PubMed 15503313Borg C, Ray-Coquard I, Philip I, Clapisson G, Bendriss-Vermare N, Menetrier-Caux C, Sebban C, Biron P, Blay JY. CD4 lymphopenia as a risk factor for febrile neutropenia and early death after cytotoxic chemotherapy in adult patients with cancer. Cancer. 2004 Dec 1;101(11):2675-80. doi: 10.1002/cncr.20688.
Results publication: PubMed 19549917Ray-Coquard I, Cropet C, Van Glabbeke M, Sebban C, Le Cesne A, Judson I, Tredan O, Verweij J, Biron P, Labidi I, Guastalla JP, Bachelot T, Perol D, Chabaud S, Hogendoorn PC, Cassier P, Dufresne A, Blay JY; European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Lymphopenia as a prognostic factor for overall survival in advanced carcinomas, sarcomas, and lymphomas. Cancer Res. 2009 Jul 1;69(13):5383-91. doi: 10.1158/0008-5472.CAN-08-3845. Epub 2009 Jun 23.
Results publication: PubMed 15905493Fry TJ, Mackall CL. The many faces of IL-7: from lymphopoiesis to peripheral T cell maintenance. J Immunol. 2005 Jun 1;174(11):6571-6. doi: 10.4049/jimmunol.174.11.6571.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Isabelle Ray Coquart principal investigator

Centre Léon Bérard, Lyon

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing interleukin 7 in people with Metastatic Breast Cancer, run by Centre Leon Berard at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

to determine the optimal schedule to deliver CYT107 during chemotherapy based on restoration of CD4 count (time frame: after 11 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01368107, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2015; AzTrials last refreshed its copy on 26 Oct 2026.