Overview

Deescalation of Endocrine Therapy Duration in Women With HR+ HER2- Breast Cancer at Very Low Risk

Status:
Not yet recruiting
Trial end date:
2034-06-01
Target enrollment:
0
Participant gender:
Female
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 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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
UNICANCER
Collaborator:
Agendia
Treatments:
Aromatase Inhibitors
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. 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.

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 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