OncoMatch/Clinical Trials/NCT05063136
Adjuvant Metronomic Capecitabine Plus Endocrine Therapy for HR+/HER2- Primary Breast Cancer
Is NCT05063136 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Capecitabine+endocrine therapy for breast cancer.
Treatment: Capecitabine+endocrine therapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 positive (positive staining accounted for more than 1% of all tumor cells)
ER and/or PR positive (positive staining accounted for more than 1% of all tumor cells)
Required: PR (PGR) positive (positive staining accounted for more than 1% of all tumor cells)
ER and/or PR positive (positive staining accounted for more than 1% of all tumor cells)
Required: HER2 (ERBB2) wild-type (IHC 0, 1+, or IHC 2+ and no fish amplification)
HER-2 negative (IHC 0, 1+, or IHC 2 + and no fish amplification)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: chemotherapy — neoadjuvant or adjuvant
Patients received radical surgery and chemotherapy (neoadjuvant or adjuvant chemotherapy)
Must have received: endocrine therapy — adjuvant
Endocrine therapy should not exceed 6 months before entering the study (calculated as 30 days per month)
Cannot have received: oral 5-FU
Exception: history of intravenous 5-FU allowed
Received oral 5-FU for more than 2 weeks before treatment (Notes: patient with a history of intravenous 5-FU was considered eligible for inclusion)
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L; Platelet ≥ 100 × 10^9/L; hemoglobin ≥ 9.0 g/dl
Kidney function
Creatinine clearance rate ≥ 50ml/min
Liver function
ALT < 2.5 × ULN; AST < 2.5 × ULN
Cardiac function
EF value of cardiac ultrasound was ≥ 55% within 14 days before randomization (for patients receiving anthracycline chemotherapy)
Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelet ≥ 100 × 10^9/L; hemoglobin ≥ 9.0 g / dl; Creatinine clearance rate ≥ 50ml/min; alanine aminotransferase (ALT)< 2.5 × Upper limit of normal range (ULN); aspartate aminotransferase (AST) < 2.5 × ULN. For patients receiving anthracycline chemotherapy, EF value of cardiac ultrasound was ≥ 55% within 14 days before randomization
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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