Actively Recruiting

Phase 2
Age: 51Years +
FEMALE
NCT05297617

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

Led by UNICANCER · Updated on 2025-03-30

696

Participants Needed

2

Research Sites

681 weeks

Total Duration

On this page

Sponsors

U

UNICANCER

Lead Sponsor

A

Agendia

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 51Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Postmenopausal women defined by prior bilateral oophorectomy, age 60 years, or age >50 and <60 years with amenorrhea for 12 months and postmenopausal hormone levels
  • ECOG performance status of 0 or 1
  • Histologically confirmed invasive unilateral breast cancer with up to 3 lesions of identical low-risk phenotype
  • No detectable metastases clinically or radiologically at inclusion
  • Complete tumor resection and adequate axillary surgery performed
  • Estrogen and/or progesterone receptor expression of 50% or more by immunohistochemistry
  • HER2 negative breast cancer as defined by ASCO criteria
  • No indication for adjuvant chemotherapy
  • Tumor stage pT1 (≤20 mm), pN0, Grade 1 or 2 or pT2 (≤30 mm), pN0, Grade 1 or 2 with age under 70 for Grade 2 pT2 tumors
  • Luminal A ultralow risk of metastatic recurrence (less than 5% risk at 10 years) confirmed by MammaPrint4 and Blueprint4 tests with MammaPrint index > +0.355
  • Eligible to receive or started adjuvant hormone therapy (letrozole, anastrozole, or exemestane) within 4 months prior to enrollment
  • Willing and able to comply with study protocol, visits, treatment, and tests
  • Affiliated with a Social Security System or equivalent
  • Signed informed consent or consent confirmed by a trusted person if unable to sign
Not Eligible

You will not qualify if you...

  • Prior neo-adjuvant hormone or chemotherapy or preoperative medical treatment
  • Any local, regional recurrence or metastatic disease
  • Non-invasive carcinoma
  • Bilateral breast cancer (except contralateral DCIS) or history of other invasive breast cancer
  • History of other malignancies except treated cervical carcinoma in situ or non-melanoma skin cancer
  • High-risk breast cancer predisposing germline mutations
  • Contraindications to anti-aromatase inhibitors
  • Participation in another therapeutic study within 30 days before inclusion
  • Other diseases requiring hospitalization or incompatible with trial treatment
  • Unable or unwilling to comply with trial requirements or understand its purpose
  • Persons deprived of liberty or under protective custody or guardianship

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

Centre Hospitalier Universitaire de Limoges

Limoges, France, 87042

Actively Recruiting

2

Institute Gustave Roussy

Villejuif, France, 94805

Not Yet Recruiting

Loading map...

Research Team

C

Clara GUYONNEAU, PharmD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here