Neoadjuvant hormone therapy for extensive ductal carcinoma in situ
Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ
This study is testing if giving hormone therapy before surgery can help women with extensive ductal carcinoma in situ avoid a mastectomy and have better treatment outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 262 (estimated) |
| Ages | 40 Years and up |
| Sex | Female |
| Sponsor | Institut Cancerologie de l'Ouest Academic / other |
| Locations | 8 sites (Angers and 7 other locations) |
| Trial ID | NCT04666961 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the impact of neoadjuvant hormone therapy on the surgical management of extensive ductal carcinoma in situ (DCIS) in patients who would typically require a mastectomy. Patients diagnosed with extensive DCIS will receive hormone therapy with either Tamoxifen or Anastrozole before surgery, with the aim of potentially allowing for less invasive surgical options. The study involves thorough screening and monitoring, including imaging assessments to evaluate the effectiveness of the hormone therapy. The goal is to improve surgical outcomes and quality of life for patients with this condition.
Who should consider this trial
Good fit: Ideal candidates are women aged 40 and older with a histological diagnosis of estrogen receptor-positive ductal carcinoma in situ who are indicated for mastectomy.
Not a fit: Patients with invasive breast carcinoma, lobular carcinoma in situ, or those who are not eligible for hormone therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the need for mastectomy in patients with extensive DCIS, leading to better quality of life and less invasive treatment options.
How similar studies have performed: Other studies have shown promise in using neoadjuvant hormone therapy for similar conditions, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient ≥ 40 years old 2. Histological diagnosis of ductal carcinoma in situ without infiltrating contingent 3. Clinical T0N0 4. Estrogen receptor positive (OR+) regardless of progesterone receptor (PR) status 5. Indication for mastectomy 6. DCIS visible on MRI performed with clip sequence 7. Effective contraceptive method for women of childbearing age who are sexually active and who have reported sexual activity. 8. Informing the patient and obtaining free, informed and written consent signed by the patient and the investigator. 9. Affiliated patient or beneficiary of the social security system. Exclusion Criteria: 1. Invasive breast carcinoma 2. Lobular carcinoma in situ 3. pN+ patient 4. Indication for conservative surgery 5. Contraindications to anastrozole or tamoxifen 6. Concomitant treatments that may interact and reduce the efficacy of tamoxifen by interaction with cytochrome CYP2D6. 7. Histologically proven multifocal lesion 8. Contraindication to breast MRI (pace maker, heart valve, metallic implant, neuronal or peripheral stimulator, severe claustrophobia, ...) 9. History of homolateral breast cancer 10. Ongoing contralateral breast cancer 11. Known mutation BRCA1 BRCA2 12. Other cancer in progress at inclusion 13. Pregnant woman, or breastfeeding, 14. Persons deprived of liberty or under guardianship or trusteeship, 15. Impossibility to undergo the medical follow-up of the trial for geographical, social, psychic or psychiatric reasons.
Where this trial is running
Angers and 7 other locations
- ICO - Site Paul Papin — Angers, France (Recruiting)
- Institut Bergonie — Bordeaux, France (Recruiting)
- Institut de cancérologie de Montpellier — Montpellier, France (Recruiting)
- Centre Antoine Lacassagne — Nice, France (Recruiting)
- Institut Curie - Site de Paris — Paris, France (Not_yet_recruiting)
- Hopital Saint Joseph — Paris, France (Recruiting)
- Institut de Cancérologie de l'Ouest — Saint-Herblain, France (Recruiting)
- Iuct-O — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Victoire BRILLAUD-MEFLAH, MD — Institut de Cancérologie de l'Ouest
- Study coordinator: Victoire BRILLAUD-MEFLAH, MD
- Email: Victoire.brillaud-meflah@ico.unicancer.fr
- Phone: 0240679818
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.