Status:
ACTIVE_NOT_RECRUITING
Prediction of Response to 2nd-line Hormone Therapy by FES CT/PET in Patients With Metastatic Breast Cancer
Lead Sponsor:
Institut Cancerologie de l'Ouest
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Clinicians are currently proposing second-line hormonal treatment to a metastatic patient who is progressing after first-line hormonal therapy if the initial disease was RH + with an increase in survi...
Detailed Description
Approximately 70% of breast cancer patients have estrogen-receptor-expressing tumors, making hormone therapy an attractive option for adjuvant and metastatic treatment. The expression of estrogen rece...
Eligibility Criteria
Inclusion
- Primary breast tumor (ductal or lobular) expressing immunohistochemistry of hormone receptors (RP + and / or RE +, with significance level ≥ 10%) but not overexpressing HER2,
- Metastatic stage with at least one lesion identifiable on the conventional balance sheet other than a liver injury,
- Patient progressing under a 1st line of hormone therapy,
- Patient candidate for a new second-line hormonal treatment,
- Postmenopausal patient,
- Karnofsky ≥ 70 or ECOG 0-1
- Life expectancy of at least 6 months
- Creatinine \<= 2.5 normal
- Social insured patient
- Signed informed consent
Exclusion
- HER2 overexpressing primary tumor in immunohistochemistry,
- Tumor that does not significantly (\<10%) express the hormonal receptors,
- Hormonal treatment in progress,
- Contraindication to a new second-line hormonal treatment,
- Patient receiving or likely to receive second-line chemotherapy in the course of the evolution of her breast cancer,
- Persons deprived of liberty or guardianship,
- Impossibility of submitting to the medical examination of the test for geographical, social or psychological reasons,
- Serious illness or comorbidity assessed at risk,
- History of cancer within 5 years, with the exception of cutaneous carcinomas other than melanomas, or carcinoma in situ of the cervix,
- Intellectual inability to sign informed consent.
Key Trial Info
Start Date :
March 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2024
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT03442504
Start Date
March 15 2017
End Date
June 1 2024
Last Update
March 12 2024
Active Locations (4)
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1
Institut de Cancerologie de l'Ouest
Angers, France, 49055
2
CHU de Brest
Brest, France, 29200
3
Centre Georges François Leclerc
Dijon, France, 21079
4
ICO René Gauducheau
Saint-Herblain, France, 44805