Circulating Tumor Cells to Guide Chemotherapy for Metastatic Breast Cancer

Phase 3

Completed

• Conditions: Breast Cancer Ductal Infiltrating Metastatic
• Interventions: Biological: Blood sampling; Other: Usual clinical and radiological criteria

• Registration Number: NCT01349842
• Lead Sponsor: Institut Curie

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.

Study Timeline

• Study Start: 2010-03-02
• Study First Submitted: 2011-05-05
• Study First Submitted QC: 2011-05-06
• Study First Posted: 2011-05-09
• Primary Completion: 2016-01
• Study Completion: 2018-11-06
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-19
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 265

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Circulating Tumor Cells	Blood sampling	Centralized determination of CTC by CellSearch® technology (Veridex), the only technology currently validated in clinical practice for the early evaluation of response to chemotherapy of breast cancers. This evaluation is performed by blood sampling comparing the CTC level before the first injection of each new line of chemotherapy. Chemotherapy can only be continued in the case of a positive CTC response. Discontinuation of chemotherapy can also be decided by the clinician on the basis of other clinical or radiological arguments.
Clinical and radiological criteria	Usual clinical and radiological criteria	Management of chemotherapy according to the usual clinical and radiological criteria adopted by the patient's attending physician.

Primary Outcome Measures

Name	Time	Method
Overall Survival	7 years	Overall survival (from date of randomization

Secondary Outcome Measures

Name	Time	Method
Improvement of quality of life	7 years
Medico-economical analysis	5 years
Time to progression, to discontinuation of therapy after 3rd line.	7 years
Measure of safety and tolerability	7 years	A list of the most frequent toxicity was established. The ranks 3 and 4 will be more specificaly collected.
Estimate the clinical interest, in particular forecast, of the circulating tumoral DNA	3 years
Comparison of CTC with usual serum tumour markers	7 years

Trial Locations

Locations (7)

Centre Georges Francois Leclerc; 🇫🇷 Dijon, France

Clinique Victor Hugo; 🇫🇷 Le Mans, France

Chu Limoges; 🇫🇷 Limoges, France

Institut Curie; 🇫🇷 Paris, France

Hopital Saint Louis; 🇫🇷 Paris, France

Institut Rene Huguenin Curie; 🇫🇷 Saint Cloud, France

Institut de Canacerologie de L'Ouest; 🇫🇷 Saint-herblain, France