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Completed

NCT Number: NCT01349842

Circulating Tumor Cells to Guide Chemotherapy for Metastatic Breast Cancer

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

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Key information

Conditions

Breast Cancer Ductal Infiltrating Metastatic

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Centre Georges Francois Leclerc, Dijon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sampling

Biological

20ml of patient peripherical blood will be collected

Usual clinical and radiological criteria

Other

Clinical examination, tumoral evaluation

Primary outcomes

  1. Overall Survival

    Time frame: 7 years

    Overall survival (from date of randomization

Secondary outcomes

  1. Measure of safety and tolerability

    Time frame: 7 years

    A list of the most frequent toxicity was established. The ranks 3 and 4 will be more specificaly collected.

  2. Improvement of quality of life

    Time frame: 7 years

  3. Time to progression, to discontinuation of therapy after 3rd line.

    Time frame: 7 years

  4. Comparison of CTC with usual serum tumour markers

    Time frame: 7 years

  5. Medico-economical analysis

    Time frame: 5 years

  6. Estimate the clinical interest, in particular forecast, of the circulating tumoral DNA

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Official study title

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

Acronym: CirCé01

Important dates

Study start
2010
Primary completion
2016
Study completion
2018
First posted
May 9, 2011
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.