Clinical trial · Observational
Association of Survival With Maintenance Therapy in Patients With Metastatic Breast Cancer After First-line Chemotherapy
NCT04258163CI-TRIAL-00043311completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To investigate the benefits and risks of maintenance chemotherapy (MCT), maintenance endocrine therapy (MET) and none maintenance therapy after first-line treatment of metastatic breast cancer (MBC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anastrozole | Drug | Anastrozole | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Fulvestrant | Drug | Fulvestrant | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Letrozole | Drug | Letrozole | ALIAS |
| Liposomal doxorubicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- MCT Group
- description
- People who received chemotherapy as a maintenance therapy after first-line chemotherapy reaching a state of no progress for at least 4 weeks. One patient only received one of the intervention drugs for maintenance therapy.
- interventionNames
- Drug: Capecitabine
- Drug: Liposomal doxorubicin
- Drug: Gemcitabine
- label
- MET Group
- description
- People who received endocrine therapy as a maintenance therapy after first-line chemotherapy reaching a state of no progress for at least 4 weeks. One patient only received one of the intervention drugs for maintenance therapy.
- interventionNames
- Drug: Fulvestrant
- Drug: Anastrozole
- Drug: Letrozole
- label
- Observation Group
- description
- People who didn't receive any maintenance therapy after first-line chemotherapy reaching a state of no progress for at least 4 weeks.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with pathologically clear invasive breast cancer between 2003 and 2018; * Female,18-75 years old; * Measurable metastatic lesion according to RECIST 1.1 evaluation criteria; * The first-line chemotherapy regimen is a breast cancer combination or single-agent chemotherapy regimen recommended by the NCCN guidelines; * First-line chemotherapy is effective (according to RECIST1.1 evaluation criteria, the efficacy is evaluated as complete response (CR), partial response (PR), or steady state (SD)); * After the last cycle of first-line chemotherapy, patients should still be in a state of no progress for at least 4 weeks; * Patients' Karnofsky performance status (KPS) scores were ≥70. Exclusion Criteria: * Unmeasurable metastatic lesion according to RECIST 1.1 evaluation criteria.
References
Publications (1)
- DERIVEDRen W, Yu Y, Hong H, Wang Y, Gao Q, Chen Y, Chen P, Zhao J, Ou Q, Lin D, Fu T, Tan Y, Li C, Xie X, Ye G, Tang J, Yao H. Clinical Evidence of Chemotherapy or Endocrine Therapy Maintenance in Patients with Metastatic Breast Cancer: Meta-Analysis of Randomized Clinical Trials and Propensity Score Matching of Multicenter Cohort Study. Cancer Res Treat. 2022 Oct;54(4):1038-1052. doi: 10.4143/crt.2021.698. Epub 2022 Feb 4. PMID 35130417