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Completed

NCT Number: NCT00911911

Proteomic Signature in Breast Cancer: Correlation With Tumor Response to Neo-adjuvant Chemotherapy

The scope of the trial is to identify proteomic signatures correlated with tumor response to neo-adjuvant chemotherapy.

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Key information

Conditions

Breast Cancer 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

Not applicable

Primary location

Intercommunal Hospital, Annemasse, 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 aged more than 18 years
  • Histologically proven breast carcinoma
  • Neo-adjuvant chemotherapy with anthracyclines and/or taxanes
  • No prior chemotherapy
  • Written informed consent

Exclusion criteria

  • Metastatic disease

Treatment and study plan

blood sampling

Procedure

Taken at different times : inclusion, at the cycle 4 and at the cycle 6 during the neoadjuvant chemotherapy

Biopsy

Procedure

Biopsy at the moment of inclusion, before neoadjuvant chemotherapy

Surgery

Procedure

Surgery after neoadjuvant chemotherapy

Primary outcomes

  1. Proteomic analysis by SELDI-TOF on the tumor biopsy and blood samples Histological response according To Chevallier and Sataloff

    Time frame: 6 months

Secondary outcomes

  1. Correlation with node invasion

    Time frame: 6 months

  2. Correlation with basal, luminal phenotypes, HER2 status or hormonal status

    Time frame: 6 months

  3. Correlation with the response measured by ultrasound after chemotherapy

    Time frame: After 3 and 5 months

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Registry information

Official study title

Analysis of the Proteomic Signature in Breast Cancer Correlated With Tumor Response in Patients Necessitating a Neo-adjuvant Chemotherapy

Acronym: SPAM

Important dates

Study start
2007
Primary completion
2009
Study completion
2012
First posted
Jun 3, 2009
Registry last updated
Mar 13, 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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