Status:
RECRUITING
Deescalation of Endocrine Therapy Duration in Women With HR+ HER2- Breast Cancer at Very Low Risk
Lead Sponsor:
UNICANCER
Collaborating Sponsors:
Agendia
Conditions:
Breast Cancer
Eligibility:
FEMALE
51+ years
Phase:
PHASE2
Brief Summary
Hormone therapy is recommended for five years in all patients with hormone receptor-positive breast cancer, but there is no consensus on its duration in low-risk tumours and especially in postmenopaus...
Detailed Description
Adjuvant ET is the cornerstone treatment of localized hormone-receptor positive breast cancer, with demonstrated benefits on overall survival (30-40% relative decrease in mortality) but also on the ri...
Eligibility Criteria
Inclusion
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- 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
- M0: Not clinically nor radiologically detectable metastases at time of inclusion
- Primary tumor completely resected and adequate axillary surgery performed, according to current standards
- IHC expression of the estrogen receptor and/or progesterone receptor ≥50%
- HER2 negative according to ASCO criteria in immunohistochemistry and/or genomic analysis (HER2 negativity is defined as IHC 0-1+, or \[IHC 2+ and FISH or CISH nonamplified\])
- No indication of adjuvant chemotherapy
- pT1 (tumor ≤20 mm), pN0, Grade 1 or Grade 2 OR pT2 (tumor ≤30 mm) and pN0, Grade 1 or Grade 2
- Note 1: patient with Grade 2 pT2pN0 tumor must be aged under 70 years of age and should receive a genomic test as part of standard care (RIHN reimbursement)
- 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: To be eligible, MammaPrint index score should be \> +0.355
- 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)
- 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
- Patients must be affiliated to a Social Security System (or equivalent)
- 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.
Exclusion
- Patients who received a neo-adjuvant hormone therapy, a neo-adjuvant or adjuvant chemotherapy or preoperative medical treatment
- Any local or regional recurrence or metastatic disease
- Non-invasive carcinoma
- Bilateral breast cancer (except in case of contralateral DCIS), or history of other invasive ipsi- or contralateral breast cancer
- Patients with a history of another malignancy, except for properly treated cervical carcinoma in situ, and non-melanoma cancer of the skin
- Women with high-risk breast cancer predisposing deleterious germline mutations
- Contra-indications to the administration of anti-aromatase inhibitors
- Patients enrolled in another therapeutic study within 30 days prior to inclusion
- Patients with any other disease or illness, which requires hospitalization or is incompatible with the trial treatment
- 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
- Persons deprived of their liberty or under protective custody or guardianship
Key Trial Info
Start Date :
October 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2035
Estimated Enrollment :
696 Patients enrolled
Trial Details
Trial ID
NCT05297617
Start Date
October 12 2022
End Date
November 1 2035
Last Update
March 30 2025
Active Locations (2)
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1
Centre Hospitalier Universitaire de Limoges
Limoges, France, 87042
2
Institute Gustave Roussy
Villejuif, France, 94805