Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ

Who is this study for? Patients with Breast Cancer
What treatments are being studied? Tamoxifen+Anastrozole
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 40
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
ICO - Site Paul Papin
RECRUITING
Angers
Institut Bergonie
RECRUITING
Bordeaux
Institut de cancérologie de Montpellier
RECRUITING
Montpellier
Centre Antoine Lacassagne
RECRUITING
Nice
Hopital Saint Joseph
RECRUITING
Paris
Institut Curie - Site de Paris
NOT_YET_RECRUITING
Paris
Institut de Cancérologie de l'Ouest
RECRUITING
Saint-herblain
IUCT-O
RECRUITING
Toulouse
Contact Information
Primary
Victoire BRILLAUD-MEFLAH, MD
Victoire.brillaud-meflah@ico.unicancer.fr
0240679818
Backup
Emilie DEBEAUPUIS
emilie.debeaupuis@ico.unicancer.fr
0240679844
Time Frame
Start Date: 2021-02-03
Estimated Completion Date: 2033-08-01
Participants
Target number of participants: 262
Treatments
Experimental: Extended ductal carcinoma in situ with mastectomy indication
Patients receive 6 months of tamoxifen or anastrozole in a neoadjuvant situation.~Tamoxifen and Anastrozole will be delivered in their original packaging at J0 and M3 :~* Tamoxifen: box of tablets dosed at 20 mg~* Anastrozole: box of tablets 1 mg. Tamoxifen will be initiated in premenopausal patients orally at a standard dose of 20mg/day as a single dose for 6 months.~Anastrozole will be administered orally to postmenopausal patients at the standard dose of 1mg/day in a single dose for 6 months.
Authors
Augustin REYNARD
Related Therapeutic Areas
Sponsors
Leads: Institut Cancerologie de l'Ouest

This content was sourced from clinicaltrials.gov