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
469 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Ductal carcinoma in situ (DCIS) makes up about 20% of new breast cancer diagnoses, with around 20% of these cases requiring mastectomy due to extensive lesions, often appearing as widespread microcalcifications. This aggressive surgery contrasts with the generally good prognosis of DCIS and can significantly affect patients' quality of life. Researchers are studying neoadjuvant hormone therapy as a way to reduce the need for mastectomy by shrinking tumors before surgery in hormone receptor-positive DCIS cases. Participants will receive 6 months of hormone therapy with either Tamoxifen (for premenopausal women) or Anastrozole (for postmenopausal women) before surgery. Treatment is given orally with Tamoxifen at 20 mg daily or Anastrozole at 1 mg daily. Imaging tests, including mammography, ultrasound, and MRI, will monitor tumor response at 3 and 6 months. Surgery type (mastectomy or tumorectomy) will depend on tumor shrinkage, followed by sentinel node detection and possible axillary dissection based on node results. Patients undergo screening with clinical exams, imaging, and biopsies before starting therapy. Biomarker and tumor environment analysis will be done before and after treatment. Post-surgery, patients have follow-ups including imaging and quality of life questionnaires at set intervals up to 10 years. Outcome measures focus on hormone therapy effectiveness after 6 months, disease-free and overall survival at 5 and 10 years, and quality of life over time.
CONDITIONS
Brief 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 infiltrating component
- Clinical stage T0N0
- Estrogen receptor positive regardless of progesterone receptor status
- Indication for mastectomy
- DCIS visible on MRI with clip sequence
- Effective contraceptive method for sexually active women of childbearing age
- Informed, free, and written 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
- Treatments that may reduce tamoxifen efficacy due to cytochrome CYP2D6 interaction
- Histologically proven multifocal lesion
- Contraindication to breast MRI (e.g., pacemaker, metallic implant, severe claustrophobia)
- History of breast cancer on the same side
- Ongoing breast cancer in the opposite breast
- Known BRCA1 or BRCA2 mutation
- Other active cancer at inclusion
- Pregnant or breastfeeding women
- Persons deprived of liberty or under guardianship
- Inability to follow medical monitoring due to geographic, social, psychological, or psychiatric reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 30 days
Participants are screened for eligibility to participate in the trial.
1 screening visit (in-person)
Duration - 6 months
Participants receive 6 months of neoadjuvant hormonal therapy with Tamoxifen or Anastrozole before surgery. Imaging monitoring is performed at 3 and 6 months during hormone therapy to assess tumor response.
Imaging visits at 3 months and 6 months during treatment
Duration - Surgery day plus immediate post-operative period
Participants undergo mastectomy or tumorectomy based on tumor response to hormone therapy. Sentinel node detection and possible axillary dissection are performed during surgery.
1 surgery visit and immediate post-operative care
Duration - Up to 10 years
Participants have postoperative consultations and follow-up visits to monitor recovery. Adjuvant treatments or re-surgical interventions may be prescribed. Follow-up includes annual examinations and mammography for up to 10 years.
Postoperative consultation and annual visits including control mammography
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
E
Emilie DEBEAUPUIS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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