Status:
RECRUITING
Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ
Lead Sponsor:
Institut Cancerologie de l'Ouest
Conditions:
Ductal Carcinoma in Situ
Extensive Disease
Eligibility:
FEMALE
40+ years
Phase:
PHASE2
Brief Summary
Ductal carcinoma in situ (DCIS) accounts for approximately 20% of newly diagnosed breast cancer cases. Of these women, 20% require radical management in the form of mastectomy because of the extent of...
Detailed Description
Description of the modalities for recruiting : Following screening and discovery of a DCIS, patients are referred to the center for surgical management. During a standard consultation, the surgeon p...
Eligibility Criteria
Inclusion
- Patient ≥ 40 years old
- Histological diagnosis of ductal carcinoma in situ without infiltrating contingent
- Clinical T0N0
- Estrogen receptor positive (OR+) regardless of progesterone receptor (PR) status
- Indication for mastectomy
- DCIS visible on MRI performed with clip sequence
- Effective contraceptive method for women of childbearing age who are sexually active and who have reported sexual activity.
- Informing the patient and obtaining free, informed and written consent signed by the patient and the investigator.
- Affiliated patient or beneficiary of the social security system.
Exclusion
- Invasive breast carcinoma
- Lobular carcinoma in situ
- pN+ patient
- Indication for conservative surgery
- Contraindications to anastrozole or tamoxifen
- Concomitant treatments that may interact and reduce the efficacy of tamoxifen by interaction with cytochrome CYP2D6.
- Histologically proven multifocal lesion
- Contraindication to breast MRI (pace maker, heart valve, metallic implant, neuronal or peripheral stimulator, severe claustrophobia, ...)
- History of homolateral breast cancer
- Ongoing contralateral breast cancer
- Known mutation BRCA1 BRCA2
- Other cancer in progress at inclusion
- Pregnant woman, or breastfeeding,
- Persons deprived of liberty or under guardianship or trusteeship,
- Impossibility to undergo the medical follow-up of the trial for geographical, social, psychic or psychiatric reasons.
Key Trial Info
Start Date :
February 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2033
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT04666961
Start Date
February 3 2021
End Date
August 1 2033
Last Update
April 22 2022
Active Locations (8)
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1
ICO - Site Paul Papin
Angers, France, 49055
2
Institut Bergonie
Bordeaux, France, 33076
3
Institut de cancérologie de Montpellier
Montpellier, France, 34298
4
Centre Antoine Lacassagne
Nice, France, 06189