Adjuvant Metronomic Capecitabine Plus Endocrine Therapy for HR+/HER2- Primary Breast Cancer
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
Breast cancer (BC) is one of most prevalent malignant tumors in the world. According to the 2020 edition of the global cancer statistics report, the incidence rate of BC has overtaken lung cancer to become the most commonly diagnosed cancer. In the past three decades, survival of patients with primary BC have been notably improved, mainly due to early detection of the disease and advances in adjuvant treatments such as endocrine therapy, chemotherapy, and anti-HER2 therapy. Patients with HR-positive and HER2-negative primary BC account for approximately 70% of all cases of early breast cancer. Endocrine therapy is the core treatment for this subtype of BC. Tamoxifen, aromatase inhibitor or their sequential administration can reduce the recurrence and mortality of this BC subtype. The results of TEXT/SOFT study showed that, compared with the traditional 5-year tamoxifen treatment, tamoxifen + OFS or aromatase inhibitor + OFS can further improve the survival of HR+/HER2- breast cancer patients. However, for premenopausal BC patients with HR+/HER2-, only 82.5% (tamoxifen plus OFS) and 85.7% (aromatase inhibitor plus OFS) of 5-year DFS were achieved. For postmenopausal BC patients, the 5-year DFS was only about 84% with aromatase inhibitors. Therefore, the survival of HR+/ HER2- BC patients needs to be further improved. Metronomic chemotherapy refers to the use of the minimum effective dose of chemotherapy drugs for long-term, uninterrupted administration to achieve anti-tumor effect. Metronomic chemotherapy has gradually been verified in clinical practice in the past 20 years. In 2020, SYSUCC-001 study has confirmed that capecitabine (650 mg/ m2 bid, for 1 years) can reduce the risk of 5-year DFS events by 36% in TNBC patients in addition to standard treatment. Besides, POTENT study has confirmed that the combination of endocrine therapy and S-1 (for one year) can further reduce the risk of iDFS by 37% in HR+/HER2- BC patients who have completed the standard treatment. Compared with capecitabine, S-1 has no indication for BC and it is not in the recommendation for BC treatment in the guidelines. Therefore, the investigators conduct this study to explore whether adjuvant Capecitabine metronomic chemotherapy for one year can further improve the survival of BC patients with HR+/ HER2- in addition to standard treatment.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek od 18 do 70 lat
- •Kobieta ze znanym statusem cyklu menstruacyjnego (przed lub w trakcie leczenia hormonalnego)
- •Rak piersi potwierdzony badaniem histologicznym, dodatni na receptor hormonów (HR+) i ujemny na HER2 (HER2-)
- •Wykonana operacja usunięcia raka piersi oraz chemioterapia (przed lub po operacji); jeśli chemioterapia przed operacją, to brak całkowitej odpowiedzi na leczenie lub przerzuty w węzłach chłonnych
- •Po leczeniu raka piersi: nie więcej niż rok od operacji, minimum 21 dni od ostatniej chemioterapii, minimum 14 dni od ostatniej radioterapii, terapia hormonalna nie dłużej niż 6 miesięcy
- •Wystarczająca funkcja szpiku kostnego i narządów (liczba neutrofili, płytek, hemoglobina, funkcja nerek i wątroby w normie)
- •Po chemioterapii anthracyclinami: funkcja serca w normie (EF ≥55%) potwierdzona badaniem USG
- •Kobieta w wieku rozrodczym: ujemny test ciąży; podpisana świadoma zgoda na uczestnictwo w badaniu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Last updated (source)
- November 4, 2024
- Sex
- Female only
Therapies / drugs in trial
Locations (1)
Henan cancer hospital
Zhengzhou, China
Trial contact
Zhenzhen Liu
Jiujun Zhu
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
You can help another person
We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.