Deescalation of Endocrine Therapy Duration in Women With HR+ HER2- Breast Cancer at Very Low Risk
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Kobieta po menopauzie (potwierdzana wiekiem ≥60 lat, lub usunięciem obydwu jajników, lub brakiem miesiączki przez co najmniej 12 miesięcy)
- •Dobry stan zdrowia i wydolność fizyczna (ECOG 0-1)
- •Udowodniony histologicznie rak piersi tylko po jednej stronie, bez zmian potencjalnie złośliwych
- •Brak widocznych przerzutów nowotworowych w momencie włączenia do badania
- •Guz całkowicie usunięty operacyjnie z odpowiednim zabiorem węzłów chłonnych
- •Obecność receptorów hormonalnych w komórkach raka (≥50%)
- •Brak białka HER2 na powierzchni komórek raka
- •Mały guz nieniszczący węzłów chłonnych (pT1 lub pT2) oraz wysoki stopień zróżnicowania komórek (Grade 1 lub 2)
✗ Disqualifies
- •Wcześniejsze leczenie chemią lub hormonami przed operacją
- •Nawrót raka w piersi lub przerzuty nowotworowe
- •Rak piersi z obydwu stron lub historia wcześniejszego raka piersi
- •Historia innego nowotworu (z wyjątkiem wylechowanego raka szyjki macicy)
- •Genetyczne predyspozycje do agresywnych postaci raka piersi
- •Przeciwwskazania do podawanego leczenia hormonalnego
Simplified criteria — AI translation
Trial details
- Minimum age
- 51 Years
- Last updated (source)
- July 21, 2026
- Sex
- Female only
Therapies / drugs in trial
Locations (2)
Centre Hospitalier Universitaire de Limoges
Limoges, France
Institute Gustave Roussy
Villejuif, France
Trial contact
Clara GUYONNEAU, PharmD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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