Clinical trial · Interventional
Letrozole Plus Metronomic Capecitabine as First-line Treatment for Patients With Recurrent or Metastatic Breast Cancer
Aromatase Inhibitors Plus Metronomic Capecitabine in Treatment of Patients With Recurrent or Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer
NCT04942899CI-TRIAL-00064367unknownPhase 2ClinicalTrials.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)
The study is designed to assess the treatment outcomes following treatment with letrozole plus metronomic capecitabine in patients with hormone receptor-positive, Her2-negative advanced breast cancer who have not received prior systemic anti-cancer therapies for their recurrent /metastatic disease.
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 |
|---|---|---|---|
| Metastasis Breast | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| letrozole | Drug | Letrozole | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- tumor response
- timeFrame
- 1 year
- description
- tumor response in form of change tumor size
Secondary outcomes (1)
- measure
- progression free survival
- timeFrame
- 1 year
- description
- decrease sites of metastasis
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients \> 18 years old with loco regionally recurrent or metastatic disease not amenable to curative therapy * Confirmed diagnosis of hormonal receptor positive (HR+)/Her2-negative breast cancer * If the patient is pre-/peri- menopausal, a luteinizing hormone releasing hormone (LHRH) agonist will be given for at least 28 days before randomization or ovarian ablation or suppression by surgery or radiotherapy * Measurable disease defined by RECIST version 1.1, * Eastern Cooperative Oncology Group (ECOG) 0-2 * Adequate organ and marrow function Exclusion Criteria: * Patients with advanced, symptomatic visceral spread (visceral crisis) * Patients diagnosed with central nervous system metastases * Second primary malignancy
References
Publications (12)
- BACKGROUNDShankar A, Rath G, Roy S, Malik A, Bhandari R, Kishor K, Barnwal K, Upadyaya S, Srivastava V, Singh R. Level of awareness of cervical and breast cancer risk factors and safe practices among college teachers of different states in india: do awareness programmes have an impact on adoption of safe practices? Asian Pac J Cancer Prev. 2015;16(3):927-32. doi: 10.7314/apjcp.2015.16.3.927. PMID 25735384
- BACKGROUNDEarly Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 May 14-20;365(9472):1687-717. doi: 10.1016/S0140-6736(05)66544-0. PMID 15894097
- BACKGROUNDWinkfield KM, Harris JR. Effective local therapy and long-term survival in breast cancer. Oncology (Williston Park). 2009 Jul;23(8):669-75. PMID 19711579
- BACKGROUNDSchwartzberg LS, Wang G, Somer BG, Blakely LJ, Wheeler BM, Walker MS, Stepanski EJ, Houts AC. Phase II trial of fulvestrant with metronomic capecitabine for postmenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer. Clin Breast Cancer. 2014 Feb;14(1):13-9. doi: 10.1016/j.clbc.2013.09.003. Epub 2013 Sep 27. PMID 24268206
- BACKGROUNDVan Cutsem E, Twelves C, Cassidy J, Allman D, Bajetta E, Boyer M, Bugat R, Findlay M, Frings S, Jahn M, McKendrick J, Osterwalder B, Perez-Manga G, Rosso R, Rougier P, Schmiegel WH, Seitz JF, Thompson P, Vieitez JM, Weitzel C, Harper P; Xeloda Colorectal Cancer Study Group. Oral capecitabine compared with intravenous fluorouracil plus leucovorin in patients with metastatic colorectal cancer: results of a large phase III study. J Clin Oncol. 2001 Nov 1;19(21):4097-106. doi: 10.1200/JCO.2001.19.21.4097. PMID 11689577
- BACKGROUNDSeidman AD, O'Shaughnessy J, Misset JL. Single-agent capecitabine: a reference treatment for taxane-pretreated metastatic breast cancer? Oncologist. 2002;7 Suppl 6:20-8. doi: 10.1634/theoncologist.7-suppl_6-20.