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CirCe01 Study: Evaluation of the Use of Circulating Tumour Cells to Guide Chemotherapy From the 3rd Line of Chemotherapy for Metastatic Breast Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer Ductal Infiltrating Metastatic

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Trial Information

CirCe01 Study: Evaluation of the Use of Circulating Tumour Cells to Guide Chemotherapy From the 3rd Line of Chemotherapy for Metastatic Breast Cancer


Phase III multicentre, randomized, open-label study comparing early evaluation of the
efficacy of chemotherapy by determination of circulating tumour cells versus conventional
clinical and radiological evaluation.


Inclusion Criteria:



- Women over the age of 18 years.

- WHO performance status: 0 to 4.

- Metastatic breast cancer.

- Progression after 2 lines of chemotherapy with decision to initiate third-line
chemotherapy.

- Disease evaluable by CTC (CTC-positive before starting chemotherapy).

- Histology: lobular or ductal adenocarcinoma.

- Information of the patient and signature of the informed consent form by the patient
or her legal representative.

Exclusion Criteria:

- Disease not evaluable by CTC (CTC-negative before starting chemotherapy).

- History of other potentially metastatic cancer (stage III or IV cancer).

- Histology other than lobular or ductal adenocarcinoma.

- Pregnant woman, women likely to become pregnant or nursing mothers.

- Persons deprived of their freedom or under guardianship.

- Women unable to comply with the medical follow-up of the study for geographical,
social or mental reasons.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Overall Survival

Outcome Description:

Overall survival (from date of randomization

Outcome Time Frame:

4 years

Safety Issue:

No

Principal Investigator

PIERGA Jean-Yves, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Curie

Authority:

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

Study ID:

IC 2009-03

NCT ID:

NCT01349842

Start Date:

January 2010

Completion Date:

Related Keywords:

  • Breast Cancer Ductal Infiltrating Metastatic
  • Breast Neoplasms
  • Carcinoma, Ductal, Breast
  • Neoplastic Cells, Circulating

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