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Reduction of hormone therapy duration in women with hormonesensitive breast cancer at very low risk of metastatic recurrence
EU CTIS ID: 2024-514480-26-00
What this study is testing
To prospectively demonstrate that an adjuvant aromatase inhibitor therapy duration limited to 2 years is associated with high distant recurrence-free interval (DRFI) at 5 years in a selected population with invasive breast cancer at low risk of metastatic recurrence.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 folliclestimulating hormone (FSH) and estradiol in the postmenopausal range
- 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
- 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.
- pT1 (tumor ≤20 mm), pN0, Grade 1 or Grade 2 OR pT2 (tumor ≤30 mm) and pN0, Grade 1 or Grade 2
You likely can't join if
- Patients who received a neo-adjuvant hormone therapy, a neo-adjuvant or adjuvant chemotherapy or preoperative medical 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
- 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
See the full eligibility criteria
- 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 folliclestimulating hormone (FSH) and estradiol in the postmenopausal range
- 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
- 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.
- pT1 (tumor ≤20 mm), pN0, Grade 1 or Grade 2 OR pT2 (tumor ≤30 mm) and pN0, Grade 1 or Grade 2
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Women with histologically proven invasive unilateral breast cancer
- M0: Not clinically nor radiologically detectable metastases at time of inclusion
- Primary tumor completely resected and adequate axillary surgery performed, according to current standards
- Patients who received a neo-adjuvant hormone therapy, a neo-adjuvant or adjuvant chemotherapy or preoperative medical 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
- 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 without complete remission for more than 5 years, 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 of inclusion
- Patients with any other disease or illness, which requires hospitalization or is incompatible with the trial treatment
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.