Randomized Trial to Evaluate the Medico-economic Interest of Taking Into Account Circulating Tumor Cells (CTC) to Determine the Kind of First Line Treatment for Metastatic, Hormone-receptors Positive, Breast Cancers.
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Ductal Infiltrating Metastatic Breast Cancer, Hormone-receptors Positive Breast Cancer
Both
Ductal Infiltrating Metastatic Breast Cancer, Hormone-receptors Positive Breast Cancer
Trial Information
Randomized Trial to Evaluate the Medico-economic Interest of Taking Into Account Circulating Tumor Cells (CTC) to Determine the Kind of First Line Treatment for Metastatic, Hormone-receptors Positive, Breast Cancers.
Inclusion Criteria:
- Women with metastatic ductal adenocarcinoma breast cancer
- 18 years old or more
- Hormone receptors positive breast cancer (ER+ and/or PR+) on the last pathological
analysis available.
- Acceptable patient's clinical situation compatible with chemotherapy or
hormonotherapy administration
- PS <4
- Life expectancy > 3 months
- Evidence of measurable or evaluable disease (RECIST 1.1 criteria)in the 28 days
before selection
- Information of the patient and signature of the informed consent form
Exclusion Criteria:
- Patient treated by chemotherapy or hormonotherapy for their metastatic disease
(treatment failure under adjuvant hormonotherapy are accepted)
- Her2 positive breast cancer
- History of other stage II or III cancer in the 5 years. History of other metastatic
cancer (whatever the time between the two cancers).
- 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, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression free survival evaluation
Outcome Description:
According to RECIST 1.1 criteria
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Jean-Yves Pierga
Investigator Role:
Principal Investigator
Investigator Affiliation:
Institut Curie
Authority:
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study ID:
IC 2011-09
NCT ID:
NCT01710605
Start Date:
February 2012
Completion Date:
Related Keywords:
- Ductal Infiltrating Metastatic Breast Cancer
- Hormone-receptors Positive Breast Cancer
- Circulating tumor cells
- Breast Cancer
- Hormone-receptors positive
- Breast Neoplasms
- Neoplastic Cells, Circulating
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