OncoMatch/Clinical Trials/NCT07467330
Dalpiciclib Combined With Endocrine Therapy and Metronomic Capecitabine vs Dalpiciclib Combined With Endocrine Therapy for First-line Treatment
Is NCT07467330 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including dalpiciclib + capecitabine + endocrine therapy and dalpiciclib + endocrine therapy for breast cancer.
Treatment: dalpiciclib + capecitabine + endocrine therapy · dalpiciclib + endocrine therapy — This study is an open-label, multicenter, randomized controlled study. It is planned to include 258 patients with HR +/HER2- advanced breast cancer with visceral metastases. Eligible subjects will be randomized 1:1 to receive dalpiciclib in combination with endocrine therapy and metronomic capecitabine chemotherapy in the experimental arm and dalpiciclib in combination with endocrine therapy in the control arm. Randomization was stratified by the number of lines of therapy for recurrent metastases (0 versus 1) and endocrine therapy (AI versus fulvestrant).
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (ER-positive (≥ 1% of tumor cells))
ER-positive and/or PR-positive are defined as having positively stained tumor cells representing ≥ 1% of all tumor cells
Required: PR (PGR) overexpression (PR-positive (≥ 1% of tumor cells))
ER-positive and/or PR-positive are defined as having positively stained tumor cells representing ≥ 1% of all tumor cells
Required: HER2 (ERBB2) negative (0/1+ by IHC; HER2/CEP17 ratio < 2.0 by ISH or HER2 gene copy number < 4)
HER2-negative are defined as having 0/1 + by standard immunohistochemistry (IHC); HER2/CEP17 ratio of less than 2.0 by ISH or HER2 gene copy number of less than 4
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: CDK4/6 inhibitor
patients who have previously been treated with CDK4/6 inhibitors
Cannot have received: antimetabolite (capecitabine)
patients who have previously been treated with ... capecitabine
Cannot have received: endocrine therapy
Exception: relapse within 2 years of adjuvant endocrine therapy
patients who relapse within 2 years of adjuvant endocrine therapy
Lab requirements
Blood counts
neutrophil count (ANC) ≥ 1,500/mm3 (1.5 x 10^9 L) (no growth factors used within 14 days); platelet count (PLT) ≥ 100,000/mm3 (100 x 10^9 L) (no corrective treatment used within 7 days); hemoglobin (Hb) ≥ 8 g/dL (80 g/L) (no corrective treatment used within 14 days)
adequate bone marrow function, defined as follows: a) neutrophil count (ANC) ≥ 1,500/mm3 (1.5 x 10^9 L) (no growth factors used within 14 days); b) platelet count (PLT) ≥ 100,000/mm3 (100 x 10^9 L) (no corrective treatment used within 7 days); c) hemoglobin (Hb) ≥ 8 g/dL (80 g/L) (no corrective treatment used within 14 days)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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