Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 262
- 试验地点
- 8
- 主要终点
- Efficacy of neoadjuvant hormonotherapy
研究概览
简要总结
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.
详细描述
Description of the modalities for recruiting :
Following screening and discovery of a DCIS, patients are referred to the center for surgical management.
During a standard consultation, the surgeon presents the study to the patient who has been diagnosed with extensive DCIS with an indication for mastectomy. The surgeon provides the patient with the information note and the consent form to participate in the study. Once the consent form is signed by the patient and the investigator, the investigator prescribes a screening test to be performed within 30 days prior to the start of hormone therapy.
Screening assessment includes :
A clinical exam and a breast imaging exam (mammography and breast and axillary ultrasound). In case of a suspicious breast ultrasound image, microbiopsy will be performed to eliminate an infiltrating component.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 CYP2D
- •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
- •Other cancer in progress at inclusion
- •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.
研究组 & 干预措施
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.
干预措施: Tamoxifen 20 mg (Drug)
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.
干预措施: Anastrozole 1Mg Tab (Drug)
结局指标
主要结局
Efficacy of neoadjuvant hormonotherapy
时间窗: 6 months of hormonotherapy
% of conservative surgeries performed after hormonotherapy
次要结局
- Predictive factors of response(3 and 6 months of hormonotherapy)
- 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)
- Quality of Life (Qol)(At baseline, at 6 months and 12 months post-surgery, and then each year for 9 years)