Skipping Hormone Therapy in Low-Risk Early Breast Cancer
ConditionBreast Cancer (Early Breast Cancer)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age60+
SponsorUNICANCER
About this trial
The goal of this clinical trial is to determine whether a selected population of women with early-stage, low-risk breast cancer can avoid hormone therapy without increasing their risk of relapse. It will also evaluate the prognosis of these participants compared to participants who received standard treatment with hormone therapy in another study, estimate the risk of specific recurrence, cardiovascular and bone health, and participants' quality of life.
All participants will have undergone surgery and possibly radiation therapy, but unlike standard care, they will not receive hormone therapy afterward. Participants will be enrolled for two years and followed for up to five years after the last participant is enrolled in the trial to monitor for long-term cancer recurrence.
Eligibility criteria
Qualifiers
Postmenopausal (underwent bilateral oophorectomy or non-chemo induced amenorrhea for 12 or more months) female participant ≥60 years of age.
New diagnosis of invasive carcinoma of the breast (ductal, tubular or mucinous) with primary tumor ≤1 cm on microscopic exam with no evidence of nodal or distant metastatic disease.
Contralateral breast described as BI-RADS (Breast Imaging-Reporting And Data System) 1 or 2 in diagnostic imaging.
Negative axillary node involvement by sentinel node biopsy or axillary node dissection (pN0) or Clinically negative axillary node involvement (cN0) after mandatory ultrasound exploration without surgical exploration of the axilla if Breast Conservative Surgery (BCS) was performed.
Disqualifiers
Have received any neo-adjuvant treatment, including hormone therapy and chemotherapy.
Have received or are eligible for adjuvant chemotherapy.
Absolute contraindication for RT in case of BCS or patients who were treated with partial breast irradiation.
Have been treated with mastectomy and with adjuvant radiotherapy received or scheduled.
Trial design
Treatments tested in this trial
- Removing Endocrine Therapy
Treatment groups
700 Participants
are divided into 1 treatment groupSponsors and collaborators
UNICANCER
Lead sponsor
Swiss Cancer Institute
Collaborator
Source ClinicalTrials.gov