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Utilisation of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer: A Prospective Cohort Study.


N/A
18 Years
70 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Utilisation of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer: A Prospective Cohort Study.


Inclusion Criteria:



- Women aged between 18 and 70

- Patient with life condition < 2 (WHO scale)

- One-sided breast adenocarcinoma with a histological evidence (all type)

- Clinical presentation which allowed a complete surgery with healthy limits

- Absence of metastasis detectable at clinical examination or radiology

- Histological evidence for homolateral axillary ganglionic invasion, whatever is the
number of node invaded (N > 1)

- The beginning of the chemotherapy within 6 weeks following the primary surgery

Exclusion Criteria:

- All metastatic affect

- Tumor classed >= T4a: cutaneous invasion, deep adherence, inflammatory breast

- All chemotherapy, hormonotherapy or radiotherapy before surgery

- Tumoral residue not removed

- Any suspect clinic or radiologic lesion, in the contralateral breast, which is not
controlled

- History of invasive neoplasm, mammary or other (except in situ carcinoma of cervix
uteri and epithelioma)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

Estimation of metastasis free survival at 5 years of the patients who had a good genomic signature. The metastasis free survival is defined by the time between the histological diagnosis of the breast cancer and the apparition of the first metastasis.

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Jean-Marc EXTRA, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Paoli-Calmettes

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

SA02/IPC 2006-003

NCT ID:

NCT00912080

Start Date:

April 2007

Completion Date:

May 2015

Related Keywords:

  • Breast Cancer
  • genomic signature
  • lymph nodes
  • no metastases
  • Breast Neoplasms

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