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

NCT04666961 | Recruiting Phase 2

• 1 other identifier: ICO-2020-06
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 8

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 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

Ductal Carcinoma in Situ; Extensive Disease; Mastectomy

Keywords

Neoadjuvant hormonotherapy; Tamoxifen; Anastrozole; conservative surgery; Breast cancer; extensive microcalcifications

Outcome Measures

Primary Outcomes (1)

• Efficacy of neoadjuvant hormonotherapy

  % of conservative surgeries performed after hormonotherapy

  6 months of hormonotherapy

Secondary Outcomes (6)

• Disease-free survival (DFS)

  5 and 10 years post-surgery

• Overall survival (OS)

  5 and 10 years post-surgery

• Pathologic Complete Response (pCR)

  6 months of hormonotherapy

• Predictive factors of response

  3 and 6 months of hormonotherapy

• Quality of Life (Qol)

  At baseline, at 6 months and 12 months post-surgery, and then each year for 4 years

Study Arms (1)

Extended ductal carcinoma in situ with mastectomy indication

EXPERIMENTAL

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.

Drug: Tamoxifen 20 mg; Drug: Anastrozole 1Mg Tab

Interventions

Tamoxifen 20 mg DRUG

Tamoxifen will be initiated in non menopausal patients orally for 6 months in a neoadjuvant situation.

Extended ductal carcinoma in situ with mastectomy indication

Anastrozole 1Mg Tab DRUG

Anastrozole will be initiated in menopausal patients orally for 6 months in a neoadjuvant situation.

Extended ductal carcinoma in situ with mastectomy indication

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (8)

ICO - Site Paul Papin

Angers, 49055, France

RECRUITING

Institut Bergonie

Bordeaux, 33076, France

RECRUITING

Institut de cancérologie de Montpellier

Montpellier, 34298, France

RECRUITING

Centre Antoine Lacassagne

Nice, 06189, France

RECRUITING

Institut Curie - Site de Paris

Paris, 75005, France

NOT YET RECRUITING

Hopital Saint Joseph

Paris, 75014, France

RECRUITING

Institut de Cancérologie de l'Ouest

Saint-Herblain, 44805, France

RECRUITING

IUCT-O

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating; Breast Neoplasms

Interventions

Tamoxifen; Anastrozole

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Victoire BRILLAUD-MEFLAH, MD

  Institut de Cancérologie de l'Ouest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoire BRILLAUD-MEFLAH, MD

CONTACT

0240679818; Victoire.brillaud-meflah@ico.unicancer.fr

Emilie DEBEAUPUIS

CONTACT

0240679844; emilie.debeaupuis@ico.unicancer.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with extensive ductal carcinoma in situ with an indication for mastectomy receiving neoadjuvant hormone therapy with Tamoxifen (non-menopausal patients) or Anastrozole (postmenopausal patients)

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 14, 2020
• Study Start: February 3, 2021
• Primary Completion: August 1, 2024
• Study Completion (Estimated): August 1, 2033
• Last Updated: April 22, 2022

Record last verified: 2022-04

Locations

FR (8)