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High Throughput Technologies to Drive Breast Cancer Patients to Specific Phase I/II Trials of Targeted Agents

18 Years
70 Years
Open (Enrolling)
Metastatic Breast Cancer

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Trial Information

High Throughput Technologies to Drive Breast Cancer Patients to Specific Phase I/II Trials of Targeted Agents

Inclusion Criteria:

- Men and Women with histologically diagnosed breast cancer

- Metastatic relapse or stage IV breast cancer at diagnosis

- Metastases amenable to biopsy

- Age <70 years old

- PS 0/1

- No restriction regarding the number of previous chemotherapy or endocrine therapies

Exclusion Criteria:

- Age <18

- Life expectancy <3 months

- Symptomatic or progressing brain metastases

- Progressive patients at the time of biopsy

- LVEF <50% (MUGA or ultrasonography)

- Inadequate bone marrow reserve or organ function as demonstrated by any of the
following laboratory values:

- Absolute neutrophil count < 1.5 x 109/L

- Platelet count < 100 x 109/L

- Haemoglobin < 90 g/L

- ASAT/ALAT > 2.5 times the upper limit of normal (ULN) if no demonstrable liver
metastases or > 5 times ULN in the presence of liver metastases

- Total bilirubin > 1.5 times ULN

- Creatinine >1.5 times ULN

- Corrected calcium > ULN

- Phosphate > ULN

- Abnormal blood coagulation that contra-indicates biopsy

- Patients deprived of liberty or placed under the authority of a tutor

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

number of patients included in early phase trials evaluating targeted drugs

Outcome Description:

To use whole genome / integrated biology approach to drive patients in early clinical trials. The goal is to include at least 30% of the patients in a clinical trial evaluating targeted agent, according to the molecular alteration detected on high throughput technologies

Outcome Time Frame:

one year after obtaining the molecular profile

Safety Issue:


Principal Investigator

Fabrice André, MD phD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Gustave Roussy, Villejuif, France


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

GRT01/0710 SAFIR-01



Start Date:

May 2011

Completion Date:

May 2017

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms