Clinical trial · Interventional
Capecitabine in Combination With Aromatase Inhibitor Versus Aromatase Inhibitors, in Hormonal Receptor Positive Recurrent or Metastatic Breast Cancer Patients, Randomized Controlled Study
Capecitabine in Combination With Aromatase Inhibitor Versus Aromatase Inhibitors, in Hormonal Receptor Positive Recurrent or Metastatic Breast Cancer Patients, Randomized Controlled Study (CONCEPT Trial)
NCT04012918CI-TRIAL-00039405CONCEPTunknownPhase 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)
Women with recurrent or metastatic breast cancer who are hormone receptor positive are candidates for first line hormonal therapy including aromatase inhibitors. In the past few years new combination therapies became available as fulvastrant or palbociclib with letrezole; increasing the progression free survival (PFS). A retrospective study showed that combination of capecitabine with aromatase inhibitors increase PFS as 1st and 2nd line line treatment another prospective study showed the same results. The aim of our study is confirm such data by a randomized controlled trial.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| A.I. | Drug | — | UNRESOLVED |
| Capecitabine plus aromatase inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A.I. + Capeciabine
- description
- Patients will receive Capecitabine 625 mg/m2 bid PO for 14 days to be repeated every 21 days until progression in combination with aromatase inhibitor if postmenopausal, addition of LHRH agonist will be added if premenopausal.
- interventionNames
- Drug: Capecitabine plus aromatase inhibitor
- type
- ACTIVE_COMPARATOR
- label
- A.I
- description
- Patients will receive aromatase inhibitors ( letrozole 2.5 mg PO per day or Anastrozole 1 mg PO per day or aromasin 25 mg PO per day) if post-menopausal, if premenopausal leutnising hormone releasing hormone (LHRH) agonist will be added to the aromatase inhibitor.
- interventionNames
- Drug: A.I.
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: 1. Adult women with locoregionally recurrent or metastatic disease not amenable to curative therapy 2. Eastern Cooperative Oncology Group (ECOG) 0-2 3. Hormone receptor positive 4. No prior systemic anti-cancer therapy for advanced ER+ disease ( hormonal therapy) 5. Measurable disease defined by revised RECIST criteria (version 1.1), or bone-only disease 6. normal laboratory values 7. Postmenopausal or premenopausal with oophorectomy (medical or surgical). Exclusion Criteria: 1. Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term 2. Prior (neo) adjuvant treatment with same aromatase inhibitor type with DFI =\< 12 months from completion of treatment. 3. Known uncontrolled or symptomatic central nervous system metastases 4. Second primary malignancy 5. Serious uncontrolled intercurrent infections or intercurrent medical or psychiatric illness 6. unable to swallow tablets, or malabsorption patients. 7. unwilling or unable to comply with study protocol or unable to meet the follow up. 8. patients who researchers considered were not suitable to participate.
References
Publications (14)
- BACKGROUNDAlvarado Miranda, A. et al. (2012) 'Combination treatment with aromatase inhibitor and capecitabine as first- or second-line treatment in metastatic breast cancer.', Journal of Clinical Oncology. American Society of Clinical Oncology, 30(15_suppl), pp. e11016-e11016. doi: 10.1200/jco.2012.30.15_suppl.e11016.
- BACKGROUNDBonneterre J, Thurlimann B, Robertson JF, Krzakowski M, Mauriac L, Koralewski P, Vergote I, Webster A, Steinberg M, von Euler M. Anastrozole versus tamoxifen as first-line therapy for advanced breast cancer in 668 postmenopausal women: results of the Tamoxifen or Arimidex Randomized Group Efficacy and Tolerability study. J Clin Oncol. 2000 Nov 15;18(22):3748-57. doi: 10.1200/JCO.2000.18.22.3748. PMID 11078487
- BACKGROUNDCardoso F, Costa A, Senkus E, Aapro M, Andre F, Barrios CH, Bergh J, Bhattacharyya G, Biganzoli L, Cardoso MJ, Carey L, Corneliussen-James D, Curigliano G, Dieras V, El Saghir N, Eniu A, Fallowfield L, Fenech D, Francis P, Gelmon K, Gennari A, Harbeck N, Hudis C, Kaufman B, Krop I, Mayer M, Meijer H, Mertz S, Ohno S, Pagani O, Papadopoulos E, Peccatori F, Penault-Llorca F, Piccart MJ, Pierga JY, Rugo H, Shockney L, Sledge G, Swain S, Thomssen C, Tutt A, Vorobiof D, Xu B, Norton L, Winer E. 3rd ESO-ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 3). Ann Oncol. 2017 Jan 1;28(1):16-33. doi: 10.1093/annonc/mdw544. No abstract available. PMID 28177437
- BACKGROUNDClarke CA, Keegan TH, Yang J, Press DJ, Kurian AW, Patel AH, Lacey JV Jr. Age-specific incidence of breast cancer subtypes: understanding the black-white crossover. J Natl Cancer Inst. 2012 Jul 18;104(14):1094-101. doi: 10.1093/jnci/djs264. Epub 2012 Jul 5. PMID 22773826
- BACKGROUNDEllis MJ, Llombart-Cussac A, Feltl D, Dewar JA, Jasiowka M, Hewson N, Rukazenkov Y, Robertson JF. Fulvestrant 500 mg Versus Anastrozole 1 mg for the First-Line Treatment of Advanced Breast Cancer: Overall Survival Analysis From the Phase II FIRST Study. J Clin Oncol. 2015 Nov 10;33(32):3781-7. doi: 10.1200/JCO.2015.61.5831. Epub 2015 Sep 14. PMID 26371134