Informations générales (source: ClinicalTrials.gov)
Single-arm Study to De-escalate Adjuvant Endocrine Therapy Duration in Women With HR+ HER2- Breast Cancer at Very Low Risk of Metastasis (LESS)
Interventional
Phase 2
UNICANCER (Voir sur ClinicalTrials)
octobre 2022
novembre 2034
29 juin 2024
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 postmenopausal women. Adjuvant endocrine therapy (ET) is
associated with substantial side effects and long-term decreased quality of life.
Moreover, while it has been shown that ET provides a real benefit in reducing the relapse
rate over time, the deterioration in quality of life may also have a negative effect on
patient adherence to treatment. It is therefore important to offer treatment to women
with low-risk cancer less intensive treatment strategies. If recent trials tested longer
durations as compared to 5 years for high-risk cancers, older trials have tested shorter
durations. The 5-year duration appeared at that time as the gold standard because of
optimal benefit-risk ratios of tamoxifen among high-risk patients. However shorter
treatments of 2-3 years were already associated with substantial benefits and may be
enough for very low risk patients.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL NOVO | VAUTIER RIT | 04/07/2024 11:05:01 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CLCC INSTITUT GUSTAVE ROUSSY | Fabrice ANDRE, Pr/MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Universitaire de Limoges - 87042 - Limoges - France | Elise DELUCHE, MD | Contact (sur clinicalTrials) | |||
Critères
Femme
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
nonamplified])
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.
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
nonamplified])
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.
1. Patients who received a neo-adjuvant hormone therapy, 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 prior to 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