Actively Recruiting
Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ
Led by Institut Cancerologie de l'Ouest · Updated on 2022-04-22
262
Participants Needed
8
Research Sites
651 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 the lesions, which most often manifest as diffuse microcalcifications. This mutilating surgical management contrasts with the excellent prognosis of this pathology and considerably alters the quality of life of patients. Neoadjuvant hormone therapy has shown its efficacy in hormone-dependent infiltrating ductal carcinomas and offers the possibility of conservative surgery after hormone therapy. Adjuvant hormone therapy with Tamoxifen or anti-aromatase drugs has shown its efficacy in the prevention of homo or contralateral recurrence. The HORNEO 01 trial fits perfectly in the current context of surgical de-escalation of ductal carcinomas in situ. The objective of the study is to evaluate the impact of neoadjuvant hormone therapy on the surgical management of extensive DCIS.
CONDITIONS
Official Title
Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient 40 years old or older
- Histological diagnosis of ductal carcinoma in situ without invasive component
- Clinical stage T0N0
- Estrogen receptor positive regardless of progesterone receptor status
- Indicated for mastectomy
- DCIS visible on MRI with clip sequence
- Effective contraception for sexually active women of childbearing age
- Informed consent signed by patient and investigator
- Affiliated with or beneficiary of social security system
You will not qualify if you...
- Invasive breast carcinoma
- Lobular carcinoma in situ
- Positive lymph node involvement (pN+)
- Indication for conservative surgery
- Contraindications to Anastrozole or Tamoxifen
- Current treatments that interfere with Tamoxifen metabolism via cytochrome CYP2D6
- Multifocal lesion proven by histology
- Contraindications to breast MRI (e.g., pacemaker, metallic implants, severe claustrophobia)
- History of cancer in the same breast
- Ongoing cancer in the opposite breast
- Known BRCA1 or BRCA2 mutation
- Other active cancers at inclusion
- Pregnant or breastfeeding women
- Persons deprived of liberty or under guardianship
- Unable to comply with medical follow-up due to geographical, social, psychological, or psychiatric reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
ICO - Site Paul Papin
Angers, France, 49055
Actively Recruiting
2
Institut Bergonie
Bordeaux, France, 33076
Actively Recruiting
3
Institut de cancérologie de Montpellier
Montpellier, France, 34298
Actively Recruiting
4
Centre Antoine Lacassagne
Nice, France, 06189
Actively Recruiting
5
Institut Curie - Site de Paris
Paris, France, 75005
Not Yet Recruiting
6
Hopital Saint Joseph
Paris, France, 75014
Actively Recruiting
7
Institut de Cancérologie de l'Ouest
Saint-Herblain, France, 44805
Actively Recruiting
8
IUCT-O
Toulouse, France, 31059
Actively Recruiting
Research Team
V
Victoire BRILLAUD-MEFLAH, MD
CONTACT
E
Emilie DEBEAUPUIS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here