OncoMatch/Clinical Trials/NCT07661927
Skipping Hormone Therapy in Low-Risk Early Breast Cancer
Is NCT07661927 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies Removing Endocrine Therapy for breast cancer (early breast cancer).
Treatment: Removing Endocrine Therapy — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression (≥ 50%)
Estrogen Receptor (ER) positive (≥ 50%)
Required: PR (PGR) expression (> 20%)
Progesterone Receptor(PR) positive (> 20%)
Required: MKI67 expression (≤ 15%)
Ki67 low (≤15%)
Required: HER2 (ERBB2) wild-type
HER2 negative (IHC or In Situ Hybridization approach) according to ASCO criteria
Excluded: BRCA1 deleterious germline mutation
Women with BRCA1, BRCA2 or other high-risk breast cancer predisposing deleterious germline mutations
Excluded: BRCA2 deleterious germline mutation
Women with BRCA1, BRCA2 or other high-risk breast cancer predisposing deleterious germline mutations
Disease stage
Required: Stage PT1A, PT1B
Grade: 1, 2 (histological grade)
primary tumor ≤1 cm on microscopic exam with no evidence of nodal or distant metastatic disease; Histological grade scored on the invasive component, 1 or 2 if pT1a or grade 1 if pT1b
Demographics
Prior therapy
Cannot have received: neo-adjuvant therapy
Have received any neo-adjuvant treatment, including hormone therapy and chemotherapy
Cannot have received: adjuvant chemotherapy
Have received or are eligible for adjuvant chemotherapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07661927 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression is a required biomarker for enrollment.
Does this trial require MKI67?
Yes, MKI67 expression is a required biomarker for enrollment.
Are patients with BRCA1 alterations eligible?
No. BRCA1 deleterious germline mutation is an exclusion criterion.
Are patients with BRCA2 alterations eligible?
No. BRCA2 deleterious germline mutation is an exclusion criterion.
What disease stage is eligible?
Stage PT1A or PT1B is required.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify