Circulating Tumor Cells to Guide Chemotherapy for Metastatic Breast Cancer

Breast Cancer Ductal Infiltrating Metastatic Clinical Trial

— CirCé01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01349842
• Other study ID #: IC 2009-03
• Status: Completed
• Phase: Phase 3
• Start date: March 2, 2010
• Est. completion date: November 6, 2018

Study information

• Verified date: March 2019
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of the use of Circulating tumour Cells to guide chemotherapy from the 3rd line of chemotherapy for metastatic breast cancer.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: November 6, 2018
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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) different from breast 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.

Related Conditions & MeSH terms

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

Intervention

Biological:
• Blood sampling
20ml of patient peripherical blood will be collected

Other:
• Usual clinical and radiological criteria
Clinical examination, tumoral evaluation

Locations

Country	Name	City	State
France	Centre Georges Francois Leclerc	Dijon
France	Clinique Victor Hugo	Le Mans
France	Chu Limoges	Limoges
France	Hopital Saint Louis	Paris
France	Institut Curie	Paris
France	Institut Rene Huguenin Curie	Saint Cloud
France	Institut de Canacerologie de L'Ouest	Saint-herblain

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Overall survival (from date of randomization	7 years
Secondary	Measure of safety and tolerability	A list of the most frequent toxicity was established. The ranks 3 and 4 will be more specificaly collected.	7 years
Secondary	Improvement of quality of life		7 years
Secondary	Time to progression, to discontinuation of therapy after 3rd line.		7 years
Secondary	Comparison of CTC with usual serum tumour markers		7 years
Secondary	Medico-economical analysis		5 years
Secondary	Estimate the clinical interest, in particular forecast, of the circulating tumoral DNA		3 years