Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Trastuzumab

Bortezomib

Proteasome Inhibitors

Antineoplastic Agents, Immunological

Trastuzumab and velcade are used according standard procedure

Combination of trastuzumab and PS-341

Fatima Cardoso, MD

The main objective of this study is to determine the feasibility of the combination of the proteasome inhibitor bortezomib (PS-341, Velcade) with trastuzumab (Herceptin) and to determine the best dose of bortezomib to combine with two trastuzumab schedules, weekly and 3-weekly.

Phase 1 study to determine the feasibility of the combination of the proteasome inhibitor bortezomib (PS-341, Velcade) with trastuzumab (Herceptin) given either weekly or 3-weekly.

Additionally, hints about efficacy of the combination will be looked upon.

PS-341 in Combination With Herceptin in Advanced Breast Cancer That Overexpresses HER-2

A Phase I, Open Label, Dose-escalating Study of the Proteasome Inhibitor PS-341 in Combination With Two Schedules of Herceptin, in Patients With Advanced Breast Cancer That Overexpresses HER-2

Combination of Velcade and Herceptine in breast metastatic patients

safety and tolerability of combinaison before recurrence of metastatic breast cance

Tolerability and safety of combination of velcade and Herceptine

Jules Bordet Institute

Dr Fatima Cardoso

Paclitaxel

Bevacizumab

Docetaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Pirkko-Liisa I Kellokumpu-Lehtinen, MD

The purpose of this study is to evaluate the efficacy and safety of the combination of biweekly docetaxel and bevacizumab in the first line treatment of metastatic breast cancer by using Response Evaluation Criteria In Solid Tumors (RECIST criteria) and NCI Common Terminology Criteria for Adverse Events (NCI CTC-AE) version 3. In addition several biochemical makers are tested as possible predictive factors.

Patients with histologically or cytologically proven measurable or nonmeasurable metastatic breast cancer are treated with a combination of biweekly docetaxel and bevacizumab as the first line treatment in multicenter phase II trial. The outcome measures would be PFS, Response rate (RECIST), duration of response, safety (NCI CTC-AE version 3) and survival. In addition several biochemical makers are tested as possible predictive factors. Treatment would be continued until PD, patient's refusal or treatment discontinuation due to side-effects or patients death. In responding patients bevacizumab would be continued either alone or in hormone receptor positive patients combined with hormone treatment until progression.

Biweekly Avastin and Docetaxel as the First Line Treatment for Patients With Metastatic Breast Cancer

Single Arm Study of the Combination of Biweekly Avastin and Docetaxel as the First Line Treatment for Patients With Metastatic Breast Cancer

side effects according to NCICTC-AE version 3.0

Oulu University Hospital

Turku University Hospital

Tampere University Hospital

professor of oncology and radiotherapy

Symptoms and General Pathology

Blood and Lymph Conditions

Immune System Diseases

Disease Progression

Lymphopenia

Leukopenia

Cytopenia

Hematologic Diseases

Leukocyte Disorders

Syndrome

Immunologic Deficiency Syndromes

Immunomodulating Agents

the patients will receive Placebo before the 1st and during the 3rd CT cycle (N=6)

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)

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)

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).

Placebo before the 1st (D0, D7, D14)and during the 3rd CT cycle (D57, D64, D71)

placebo

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 7

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)

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)

Isabelle Ray Coquart

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.

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

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

Evolution of CD4 count from Day 0 to Week 11 with repeated measures from D0 to W12 (D0, D21, D57, D78).

Time from randomisation to first evidence of progression or death of any cause.

Number of CT cycles, CT dose delays and/or reduction, CT discontinuation

Evolution of CD4 count from Day 0 to end of study visit

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).

Analysis of the functional response of T cells, DC subsets and NK cells

* 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.

Evaluation of T cell receptor diversity using ImmuneTraCkeR test and Constel'ID software (ImmunID Technologies, Grenoble, France).

Number of patients with AEs (any type any grade) using NCI-CTCAE scale (version 4.0) from D0 to W12

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PS-341 in Combination With Herceptin in Advanced Breast Cancer That Overexpresses HER-2	NCT00199212	Carcinoma Breas...	Combination of ...	18 Years -	Jules Bordet Institute
Biweekly Avastin and Docetaxel as the First Line Treatment for Patients With Metastatic Breast Cancer	NCT00979641	Neoplasms	Docetaxel	18 Years -	Tampere University Hospital
Study Evaluating Impact of IL-7 on CD4 Lymphopenia, Risks of Severe Haematological Toxicity and Tumor Progression in Metastatic Breast Cancer Patients	NCT01368107	Metastatic Brea...	placebo interleukin 7 interleukin 7 interleukin 7	18 Years -	Centre Leon Berard

Spots Global Cancer Trial Database for metastatic breast cancer patients