OncoMatch/Clinical Trials/NCT05297617
Deescalation of Endocrine Therapy Duration in Women With HR+ HER2- Breast Cancer at Very Low Risk
Is NCT05297617 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Anti-aromatase inhibitor for breast cancer.
Treatment: Anti-aromatase inhibitor — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 IHC expression of the estrogen receptor ≥50% (≥50%)
IHC expression of the estrogen receptor and/or progesterone receptor ≥50%
Required: PR (PGR) IHC expression of the progesterone receptor ≥50% (≥50%)
IHC expression of the estrogen receptor and/or progesterone receptor ≥50%
Required: HER2 (ERBB2) HER2 negative according to ASCO criteria in immunohistochemistry and/or genomic analysis (HER2 negativity is defined as IHC 0-1+, or [IHC 2+ and FISH or CISH nonamplified]) (IHC 0-1+, or [IHC 2+ and FISH or CISH nonamplified])
HER2 negative according to ASCO criteria in immunohistochemistry and/or genomic analysis (HER2 negativity is defined as IHC 0-1+, or [IHC 2+ and FISH or CISH nonamplified])
Disease stage
Required: Stage PT1, PT2, PN0
Grade: Grade 1Grade 2
pT1 (tumor ≤20 mm), pN0, Grade 1 or Grade 2 OR pT2 (tumor ≤30 mm) and pN0, Grade 1 or Grade 2
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: neo-adjuvant hormone therapy
Patients who received a neo-adjuvant hormone therapy
Cannot have received: neo-adjuvant chemotherapy
Patients who received a neo-adjuvant or adjuvant chemotherapy
Cannot have received: adjuvant chemotherapy
Patients who received a neo-adjuvant or adjuvant chemotherapy
Cannot have received: preoperative medical treatment
Patients who received a preoperative medical treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05297617 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior neo-adjuvant hormone therapy, neo-adjuvant chemotherapy, adjuvant chemotherapy disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 IHC expression of the estrogen receptor ≥50% is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR IHC expression of the progesterone receptor ≥50% is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 HER2 negative according to ASCO criteria in immunohistochemistry and/or genomic analysis (HER2 negativity is defined as IHC 0-1+, or [IHC 2+ and FISH or CISH nonamplified]) is a required biomarker for enrollment.
What disease stage is eligible?
Stage PT1 or PT2 or PN0 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