Shorter hormone therapy for low-risk breast cancer in postmenopausal women

Single-arm Study to De-escalate Adjuvant Endocrine Therapy Duration in Women With HR+ HER2- Breast Cancer at Very Low Risk of Metastasis

This study is testing if postmenopausal women with low-risk hormone receptor-positive breast cancer can safely take hormone therapy for just two years instead of five to see if it keeps them healthy while causing fewer side effects.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 696 (estimated)
• Ages: 51 Years and up
• Sex: Female
• Sponsor: UNICANCER (other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Limoges and 1 other locations)
• Trial ID: NCT05297617 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of reducing the duration of adjuvant endocrine therapy from the standard five years to two years for postmenopausal women with hormone receptor-positive, HER2-negative breast cancer at very low risk. The study aims to evaluate whether this shorter treatment duration can maintain high survival rates while minimizing side effects and improving the quality of life for patients. Participants will receive an anti-aromatase inhibitor as part of their treatment regimen. The trial will assess the impact of this de-escalation strategy on disease-free survival and overall patient well-being.

Who should consider this trial

Good fit: Ideal candidates for this study are postmenopausal women with histologically confirmed invasive unilateral breast cancer that is hormone receptor-positive and HER2-negative.

Not a fit: Patients with high-risk breast cancer or those with detectable metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce treatment-related side effects and improve the quality of life for women with low-risk breast cancer.

How similar studies have performed: Previous studies have indicated that shorter durations of endocrine therapy may be effective for low-risk patients, suggesting potential success for this approach.

Eligibility criteria

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. 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)
10. 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
11. 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)
12. 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
13. Patients must be affiliated to a Social Security System (or equivalent)
14. 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 Criteria:

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

Where this trial is running

Limoges and 1 other locations

• Centre Hospitalier Universitaire de Limoges — Limoges, France (RECRUITING)
• Institute Gustave Roussy — Villejuif, France (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Clara GUYONNEAU, PharmD

Conditions: Breast Cancer