Clinical trial · Observational
Evaluation of Degree of Conversion of HER2 Receptor Between Primary Breast Cancer and Metastasis
NCT01377363CI-TRIAL-00064626completedClinicalTrials.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)
This is a Prospective Clinical Trial without drugs, to determine the HER2 status in the metastasis of patients with primary breast cancer HER2. 32 Sites have been taking part in this Clinical 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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Not treatment
- description
- Locally recurrent breast carcinoma or metastatic
Primary outcomes (1)
- measure
- Evaluation of degree of conversion of human epidermal growth factor receptor 2 (HER2) receptor between primary breast cancer and metastases
- timeFrame
- 2 years since the beginning of the Study
- description
- The conversion of HER2 is defined as the variation of the HER2 status between the primary tumor and the metastases, both from an initially negative to positive state and from an initially positive to negative state. The definition of the different molecular subtypes of primary breast cancer will be the following: * Luminal: immunohistochemical phenotype Estrogen Receptor (ER) positive and/or Progesterone Receptor (PR) positive, independently of HER2 status. * Triple negative: immunohistochemical phenotype ER negative, PR negative and HER2 negative. * HER2: immunohistochemical phenotype ER negative, PR negative and HER2 positive. For the calculation of this probability, a sample of the remnant of the primary tumor and the biopsy of the metastasis, performed according to the usual clinical practice of the site, will be sent to the central laboratory for analysis by immunohistochemistry (IHQ) and in situ hybridization (FISH) analysis.
Secondary outcomes (10)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who have given their written informed consent to participate in the study. * Women over 18 years. * Breast cancer locally recurrent or metastatic at first relapse or after successive progressions. * Patient has to have available a sample of the primary tumor in paraffin. * Patients who are planning for the next 6 weeks, the biopsy (fine needle aspiration / drainage of fluid cavities, open biopsy, core biopsy) of locally recurrent or metastatic lesion \[local relapse in the chest wall, nodal , cutaneous or subcutaneous metastases, peripheral lymph nodes and other soft tissues accessible, bone metastases, visceral metastases (lung, liver, brain, etc..) or pleural effusion / ascites / pericardial / cerebrospinal\] according to clinical practice center. Exclusion Criteria: * Patients with cognitive impairment that might impede a proper understanding of the written informed consent, according to medical criteria. * Ipsilateral breast local relapses or contralateral breast away. * Patients diagnosed with a second neoplasm, with the exception of cervical carcinoma in situ and non-melanoma skin carcinoma treated properly.
References
Publications (5)
- RESULTde Duenas EM, Hernandez AL, Zotano AG, Carrion RM, Lopez-Muniz JI, Novoa SA, Rodriguez AL, Fidalgo JA, Lozano JF, Gasion OB, Carrascal EC, Capilla AH, Lopez-Barajas IB, Mateu MM, de Ceballos Reyna MH, Ferrando AO, Janez NM, Ballerini VC, Torres AA, Catalan G, Saenz JA, Menjon S, Gonzalez-Angulo AM. Prospective evaluation of the conversion rate in the receptor status between primary breast cancer and metastasis: results from the GEICAM 2009-03 ConvertHER study. Breast Cancer Res Treat. 2014 Feb;143(3):507-15. doi: 10.1007/s10549-013-2825-2. Epub 2014 Jan 11. PMID 24414130
- RESULTLiu ZB, Ezzedine NE, Eterovic AK, Ensor JE, Huang HJ, Albanell J, Choi DS, Lluch A, Liu Y, Rojo F, Wong H, Martinez-Duenas E, Guerrero-Zotano A, Shao ZM, Darcourt JG, Mills GB, Dave B, Chang JC. Detection of breast cancer stem cell gene mutations in circulating free DNA during the evolution of metastases. Breast Cancer Res Treat. 2019 Nov;178(2):251-261. doi: 10.1007/s10549-019-05374-x. Epub 2019 Aug 6. PMID 31388936
- RESULTCejalvo JM, Martinez de Duenas E, Galvan P, Garcia-Recio S, Burgues Gasion O, Pare L, Antolin S, Martinello R, Blancas I, Adamo B, Guerrero-Zotano A, Munoz M, Nuciforo P, Vidal M, Perez RM, Chacon Lopez-Muniz JI, Caballero R, Peg V, Carrasco E, Rojo F, Perou CM, Cortes J, Adamo V, Albanell J, Gomis RR, Lluch A, Prat A. Intrinsic Subtypes and Gene Expression Profiles in Primary and Metastatic Breast Cancer. Cancer Res. 2017 May 1;77(9):2213-2221. doi: 10.1158/0008-5472.CAN-16-2717. Epub 2017 Mar 1. PMID 28249905
- RESULTLluch A, Gonzalez-Angulo AM, Casadevall D, Eterovic AK, Martinez de Duenas E, Zheng X, Guerrero-Zotano A, Liu S, Perez R, Chen K, Chacon JI, Mills GB, Antolin S, Blancas I, Lopez-Serra P, Carrasco E, Caballero R, Prat A, Rojo F, Gonzalez-Perez A, Meric-Bernstam F, Albanell J. Dynamic clonal remodelling in breast cancer metastases is associated with subtype conversion. Eur J Cancer. 2019 Oct;120:54-64. doi: 10.1016/j.ejca.2019.07.003. Epub 2019 Sep 4. PMID 31491604
- RESULTGarcia-Recio S, Thennavan A, East MP, Parker JS, Cejalvo JM, Garay JP, Hollern DP, He X, Mott KR, Galvan P, Fan C, Selitsky SR, Coffey AR, Marron D, Braso-Maristany F, Burgues O, Albanell J, Rojo F, Lluch A, de Duenas EM, Rosen JM, Johnson GL, Carey LA, Prat A, Perou CM. FGFR4 regulates tumor subtype differentiation in luminal breast cancer and metastatic disease. J Clin Invest. 2020 Sep 1;130(9):4871-4887. doi: 10.1172/JCI130323.