Circulating Tumor Cells to Guide Chemotherapy for Metastatic Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

265 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-02

Study Completion Date

2018-11-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Blood Levels of Tumor Cells in Predicting Response in Patients Receiving First-Line Chemotherapy for Stage IV Breast Cancer

NCT00898014

Breast Cancer

COMPLETED

Study of Metabolites Markers in Adjuvant Breast Cancer

NCT03367208

Breast Neoplasms

COMPLETED

Are CK+/CD45+ Double-Positive Circulating Cells of Tumor-origin? Characterization in METAstatic Breast Cancer

NCT06408038

Metastatic Breast Cancer

COMPLETED NA

Prospective Validation Trial of Circulating Tumor Cells (CTCs) in Women With Metastatic Breast Cancer

NCT00493350

Breast Cancer

COMPLETED

Enumeration and Molecular Characterization of Circulating Tumour Cells in Women With Metastatic Breast Cancer

NCT01322893

Metastatic Breast Cancer

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Ductal Infiltrating Metastatic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Circulating Tumor Cells

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.

Group Type EXPERIMENTAL

Blood sampling

Intervention Type BIOLOGICAL

20ml of patient peripherical blood will be collected

Clinical and radiological criteria

Management of chemotherapy according to the usual clinical and radiological criteria adopted by the patient's attending physician.

Group Type OTHER

Usual clinical and radiological criteria

Intervention Type OTHER

Clinical examination, tumoral evaluation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blood sampling

20ml of patient peripherical blood will be collected

Intervention Type BIOLOGICAL

Usual clinical and radiological criteria

Clinical examination, tumoral evaluation

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No