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NCT Number: NCT01574170

Prospective Construction and Validation of a Prognostic Score to Identify Among Patients With Metastatic Breast Cancer Those Who Benefit From a Third Line Chemotherapy in Terms of Overall Survival

This is a biomedical study of interventional type. The trial will include 270 patients (180 patients in the first cohort and 90 patients in a second cohort) over a period of 3 years + 2 years of follow up.

This prospective study will be conduct in patients who will receive a third line chemotherapy for metastatic breast cancer.

The main objective of the study (first cohort) is to identify patients who benefit from a third line treatment in terms of overall survival with a score established from clinical, histological, but also biological "classic" and "innovative" (account of circulating tumor cells) criteria, all of these criteria must be measurable before the introduction of the 3rd line.

This score will then be validated on the 2nd cohort.

There will be no interruption of inclusions between first and second cohort of patients

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Key information

Conditions

Metastatic Breast Cancer Starting a Third Line Chemotherapy Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

C.M.C.O. Claude Bernard, Albi, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women of more than 18 years old
  • WHO 0-4
  • Metastatic breast cancer
  • Progression after two lines of chemotherapy with treatment decision by investigator to start a third-line chemotherapy
  • Evaluable disease
  • Histology: breast carcinoma whatever the histological type, grade, hormone receptor expression and HER-2
  • Patient able to complete the EORTC PAL 15 Questionnaire
  • Patient member in a national insurance scheme
  • Informed consent obtained and signed by the patient

Exclusion criteria

  • History of other (s) cancer (s) potentially metastatic (s)
  • Woman participating in a third line chemotherapy clinical trial
  • Pregnant women or nursing mothers can not participate in the study
  • Patient under legal guardianship
  • Patient unable to undergo medical test for various reasons including social or psychological reasons.

Treatment and study plan

Construction of a prognostic score (non-drug intervention types)

Other

Record of clinical, histological and biological data and questionnaires data in patients starting a third line metastatic until progression

Primary outcomes

  1. Overall survival defined as the time from patient inclusion to the date of death or date of last follow-up news (censured data)

    Time frame: 11 years

Secondary outcomes

  1. The time to progression, defined as the time from patient inclusion to the date of the first documented tumor progression

    Time frame: 11 years

  2. Quality of life using the EORTC QLQ-C15-PAL Questionnaire

    Time frame: 11 years

  3. Patient satisfaction regarding therapeutic decisions at inclusion using a specific questionnaire developed by Llewellyn-Thomas

    Time frame: 11 years

  4. Oncologists satisfaction regarding the management and communication with the patient will be studied at baseline and at the time or progression using the Likert ordinal scale

    Time frame: 7 years

  5. Regret or not of the patient to have followed a 3rd line of chemotherapy will be recorded at the end of the treatment using the "Decision regret scale" Questionnaire, established by A. O'Connor

    Time frame: 11 years

  6. Safety evaluated according to the classification of NCI CTCAE (Common Terminology Criteria for Adverse Events) V4.0

    Time frame: 11 years

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Acronym: METAL3

Important dates

Study start
2012
Primary completion
2023
Study completion
2023
First posted
Apr 10, 2012
Registry last updated
Apr 17, 2026

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.

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