Health TrialsbyHealthPanel

Skipping Hormone Therapy in Low-Risk Early Breast Cancer

ConditionBreast Cancer (Early Breast Cancer)
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Removing Endocrine Therapy

    Drug

    The standard of care endocrine therapy (Tamoxifene, Letrozole, Anastrozole or Exemestane) will not be received by the participant during the study.

Treatment groups

700 Participants
are divided into 1 treatment group
Group A: No Endocrine TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Relapse-free interval

Relapse-free interval (RFI) is defined as the delay between initial treatment and the first occurrence of i) ipsilateral breast tumor recurrence, ii) distant or locoregional recurrence or iii) death from breast cancer, according to the STEEP system definition version 2.0 (Tolaney SM et al., J Clin Oncol 2021)

Time frame
At 5 years after the last treatment

Secondary outcomes

1

Incidence of Ipsilateral Ductal Carcinoma In Situ (DCIS)

Time frame
At 5 years after the last treatment
2

Incidence of invasive contralateral breast cancer

Time frame
At 5 years after the last treatment
3

Distant disease free survival (DDFS)

Distant disease free survival is defined as the delay between date of inclusion and distant tumor relapse or death from any cause, whichever occurs first.

Time frame
At 5 years after the last treatment
4

Relapse free survival (RFS)

Relapse-free survival is defined as the delay between date of inclusion and tumor relapse (local, regional, or distant) or death from any cause, whichever occurs first.

Time frame
5 years after the last treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

UNICANCER

Lead sponsor

Swiss Cancer Institute

Collaborator

Source ClinicalTrials.gov
Apply now