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Skipping Hormone Therapy in Low-Risk Early Breast Cancer
EU CTIS ID: 2025-523683-20-00
What this study is testing
To determine if women ≥ 60 years of age with clear margins of excision after surgery for node-negative breast cancer with tumors ≤ 1 cm and Luminal A characteristics (ER and PR positive, HER2⁻, and Ki67 ≤ 15%) who are treated with adjuvant radiotherapy (if they underwent breast-conserving surgery, BCS) and forgo adjuvant ET have an acceptable low risk of relapse or death from breast cancer.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Postmenopausal (underwent bilateral oophorectomy or non-chemo induced amenorrhea for 12 or more months) female participant ≥60 years of age.
- The participant is willing and able to comply with the protocol for the duration of the study, including scheduled visits, treatment strategy, laboratory tests and other study procedures.
- Participants must be affiliated with a Social Security System (or equivalent).
- The participant must have signed a written informed consent form before any trialspecific procedures. When the participant is physically unable to give written consent, an impartial witness of her choice, independent from the investigator or the sponsor, can confirm the participant’s consent in writing.
- New diagnosis of invasive carcinoma of the breast (ductal, tubular or mucinous) with primary tumor ≤1 cm on microscopic exam (pT1a-b), with no evidence of nodal or distant metastatic disease.
- Contralateral breast described as BI-RADS 1 or 2 in diagnostic imaging.
You likely can't join if
- Have received any neo-adjuvant treatment, including hormone therapy and chemotherapy.
- History of non-breast cancer malignancies if not disease-free for > 5 years and considered low risk of recurrence except for treated carcinoma in situ of the cervix, endometrium or colon, melanoma in situ and basal or squamous cell carcinoma of the skin.
- Non-malignant severe disease associated with a life expectancy < 10 years.
- Women with BRCA1, BRCA2 or other high-risk breast cancer predisposing deleterious germline mutations.
- Enrolled in another therapeutic study within 30 days prior to inclusion.
- Unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.
See the full eligibility criteria
- Postmenopausal (underwent bilateral oophorectomy or non-chemo induced amenorrhea for 12 or more months) female participant ≥60 years of age.
- The participant is willing and able to comply with the protocol for the duration of the study, including scheduled visits, treatment strategy, laboratory tests and other study procedures.
- Participants must be affiliated with a Social Security System (or equivalent).
- The participant must have signed a written informed consent form before any trialspecific procedures. When the participant is physically unable to give written consent, an impartial witness of her choice, independent from the investigator or the sponsor, can confirm the participant’s consent in writing.
- New diagnosis of invasive carcinoma of the breast (ductal, tubular or mucinous) with primary tumor ≤1 cm on microscopic exam (pT1a-b), with no evidence of nodal or distant metastatic disease.
- Contralateral breast described as BI-RADS 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 BCS was performed.
- ER positive (≥ 50%) and PR positive (> 20%), Ki67 low (≤15%) and HER2 negative (IHC or In Situ Hybridization approach) according to ASCO criteria.
- Histological grade scored on the invasive component, 1 or 2 if pT1a or grade 1 if pT1b.
- Treated by mastectomy or BCS with microscopically clear resection margins defined as “no-ink on tumor” or ≥1 mm for invasive and non-invasive disease or no residual disease on re-excision.
- If BCS was performed, participants must have received or have scheduled adjuvant local radiotherapy within 3 months after surgery, as follows : - whole breast adjuvant radiotherapy, - with appropriate fractionation (15, 5, 16 or 25 fractions), as per current standards - with or without a boost to the tumor bed, - delivered in a sequential or simultaneous manner, as per radiation oncologist’s choice. - whole breast irradiation volumes will be defined as per current guidelines
- No indication of adjuvant chemotherapy.
- Have received any neo-adjuvant treatment, including hormone therapy and chemotherapy.
- History of non-breast cancer malignancies if not disease-free for > 5 years and considered low risk of recurrence except for treated carcinoma in situ of the cervix, endometrium or colon, melanoma in situ and basal or squamous cell carcinoma of the skin.
- Non-malignant severe disease associated with a life expectancy < 10 years.
- Women with BRCA1, BRCA2 or other high-risk breast cancer predisposing deleterious germline mutations.
- Enrolled in another therapeutic study within 30 days prior to inclusion.
- Unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.
- Persons deprived of their liberty or under protective custody or guardianship.
- 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.
- Invasive lobular breast cancer.
- Bilateral breast cancer or history of other invasive ipsi- or contralateral breast cancer.
- Multifocal or multicentric disease.
- Disease limited to microinvasion only (< 1 mm).
- Evidence of lymphovascular invasion.
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.