Reduction of hormone therapy duration in women with hormone-sensitive breast cancer at very low risk of metastatic recurrence

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 696

Inclusion Criteria

1.Postmenopausal women: Postmenopausal status is defined by any of the following:
-Prior bilateral oophorectomy
-Age =60 years
-Age >50 and <60 years and amenorrheic for at least 12 months, and follicle-stimulating hormone (FSH) and estradiol in the postmenopausal range
2.Eastern Cooperative Oncology Group (ECOG) performance status 0-1
3.Women with histologically proven invasive unilateral breast cancer
Note: In case of a multifocal invasive tumor, all lesions (maximum 3 infiltrating lesions allowed) must be of identical phenotype and low biological risk
4.M0: Not clinically nor radiologically detectable metastases at time of inclusion
5.Primary tumor completely resected and adequate axillary surgery performed, according to current standards
6.IHC expression of the estrogen receptor and/or progesterone receptor =50%
7.HER2 negative according to ASCO criteria in immunohistochemistry and/or genomic analysis (HER2 negativity is defined as IHC 0-1+, or [IHC 2+ and FISH or CISH non-amplified])
8.No indication of adjuvant chemotherapy
9.Patient considered has having a luminal A ultralow risk of metastatic recurrence (i.e. less than 5% risk of metastatic relapse at 10 years) according to MammaPrint® and Blueprint® tests.
Note 1: MammaPrint test is indicated for patients with pT1c-2, pN0/pN1mic and grade 2, with no indication of chemotherapy.
Note 2: Up to 80 patients aged =65 years and pT1 (tumor =20 mm) and pN0 and grade 1 and Ki67 =10% will be recruited
Note 3: To be eligible, MammaPrint index score should be > +0.355
10.Patients eligible to receive or have recently started (with a maximum of 4 months of adjuvant hormone therapy prior to enrollment) an adjuvant hormone therapy (letrozole, anastrozole, or exemestane)
11.Patient is willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures
12.Patients must be affiliated to a Social Security System (or equivalent)
13.Patient must have signed a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient’s consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 556

Exclusion Criteria

1.Patients who received a neo-adjuvant hormone therapy (only 4 months prior to enrollment will be allowed), a neo-adjuvant or adjuvant chemotherapy or preoperative medical treatment
2.Any local or regional recurrence or metastatic disease
3.Non-invasive carcinoma
4.Bilateral breast cancer (except in case of contralateral DCIS), or history of other invasive ipsi- or contralateral breast cancer
5.Patients with a history of another malignancy except for properly treated cervical carcinoma in situ and non-melanoma cancer of the skin
6.Women with high-risk breast cancer predisposing deleterious germline mutations
7.Contra-indications to the administration of anti-aromatase inhibitors
8.Patients enrolled in another therapeutic study within 30 days of inclusion
9.Patients with any other disease or illness, which requires hospitalization or is incompatible with the trial treatment
10.Patients unwilling or unable to comply with trial obligations for geographic, social, physical or psychological reasons, or who are unable to understand the purpose and procedures of the trial
11.Persons deprived of their liberty or under protective custody or guardianship

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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