Clinical trial NCT01349842: Circulating Tumor Cells to Guide Chemotherapy for Metastatic Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer Ductal Infiltrating Metastatic
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2011-05-09
Enrollment: 265
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall Survival
timeFrame: 7 years
Secondary outcomes:
measure: Measure of safety and tolerability
timeFrame: 7 years
measure: Improvement of quality of life
timeFrame: 7 years
measure: Time to progression, to discontinuation of therapy after 3rd line.
timeFrame: 7 years
measure: Comparison of CTC with usual serum tumour markers
timeFrame: 7 years
measure: Medico-economical analysis
timeFrame: 5 years
measure: Estimate the clinical interest, in particular forecast, of the circulating tumoral DNA
timeFrame: 3 years
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Georges Francois Leclerc
city: Le Mans
country: France
facility: Clinique Victor Hugo
city: Limoges
country: France
facility: Chu Limoges
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Hopital Saint Louis
city: Saint Cloud
country: France
facility: Institut Rene Huguenin Curie
city: Saint-herblain
country: France
facility: Institut de Canacerologie de L'Ouest
Study officials:
affiliation: Institut Curie
name: PIERGA Jean-Yves, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cabel L, Berger F, Cottu P, Loirat D, Rampanou A, Brain E, Cyrille S, Bourgeois H, Kiavue N, Deluche E, Ladoire S, Campone M, Pierga JY, Bidard FC. Clinical utility of circulating tumour cell-based monitoring of late-line chemotherapy for metastatic breast cancer: the randomised CirCe01 trial. Br J Cancer. 2021 Mar;124(7):1207-1213. doi: 10.1038/s41416-020-01227-3. Epub 2021 Jan 21.
citation: Helissey C, Berger F, Cottu P, Dieras V, Mignot L, Servois V, Bouleuc C, Asselain B, Pelissier S, Vaucher I, Pierga JY, Bidard FC. Circulating tumor cell thresholds and survival scores in advanced metastatic breast cancer: the observational step of the CirCe01 phase III trial. Cancer Lett. 2015 May 1;360(2):213-8. doi: 10.1016/j.canlet.2015.02.010. Epub 2015 Feb 17.