Evaluation of Degree of Conversion of HER2 Receptor Between Primary Breast Cancer and Metastasis
NCT ID: NCT01377363
Last Updated: 2023-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
236 participants
OBSERVATIONAL
2009-12-11
2012-11-30
Brief Summary
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Detailed Description
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Observation period: Each patient in the study will be observed from their inclusion in the study until 1 year after the inclusion of the last patient in the study. These visits will match with the scheduled follow-up visits made by the patient according to the usual clinical practice of the site.
Determination of sample size: The calculation of the sample size will be based on determining a number of patients that will achieve the main objective of the study.
The fulfillment of the secondary objectives of the study will be obtained from the size determined by the main objective.
Main objective of the study is to: Prospectively determine the probability of conversion of the HER2 stage between the different subtypes of primary breast cancer (luminal, triple negative and HER2) and their respective metastases.
A review of the literature has allowed to find several published works with varying percentages of HER2 disagreements determined by IHQ + FISH or FISH, which have allowed to estimate an average percentage of disagreements of 10.45% (range between 4% and 20%). Considering the hypothesis that the level of disagreement in each of the different subtypes of primary, luminal, triple negative and HER2 breast cancer, is presented in an approximately similar frequency, that is to say approximately 10.45%.
From the aforementioned data, an average conversion rate to be expected of 10% will be assumed. An alpha risk of 0.05 will be accepted, with an accuracy of +/- 0.09 percentage units, with a bilateral contrast, for which it would be necessary to include 43 patients for each of the three groups mentioned above (luminal, triple negative and HER2), which consequently includes 129 patients. If a loss rate is assumed (patients registered with biopsies finally not performed or not valid, or with inconclusive results or reflecting other diagnoses) of approximately 25%, the necessary size would increase to a total of 172 patients.
Based on these calculations, the final sample size would be 175 patients
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Not treatment
Locally recurrent breast carcinoma or metastatic
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Roche Farma, S.A
INDUSTRY
Spanish Breast Cancer Research Group
OTHER
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Hospital Clinico Universitario de Valencia
Study Director
Role: STUDY_DIRECTOR
Consorcio Hospitalario Provincial de Castellon
Locations
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Hospital Virgen de los Lirios
Alcoy, Alicante, Spain
Hospital General de Elda
Elda, Alicante, Spain
Hospital de Son Llàtzer
Palma de Mallorca, Balearic Islands, Spain
Althaia Xarxa Asistencial de Manresa
Manresa, Barcelona, Spain
Consorcio Hospitalario Provincial de Castellón
Castellon, Castellón, Spain
Hospital Punta de Europa
Algeciras, Cádiz, Spain
Hospital Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain
Complejo Hospitalario Universitario de A Coruña
A Coruña, La Coruña, Spain
Hospital Materno Insular de Canarias
Las Palmas de Gran Canaria, Las Palmas, Spain
Fundación Hospital Alcorcón
Alcorcón, Madrid, Spain
Hospital Universitario Severo Ochoa
Leganés, Madrid, Spain
Hospital Universitario Quirón salud Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Tenerife, Spain
Hospital de Sagunto
Sagunto, Valencia, Spain
Hospital del Mar
Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, , Spain
Hospital San Pedro de Alcantara
Cáceres, , Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona, , Spain
Hospital Universitario Virgen de las Nieves
Granada, , Spain
Hospital Universitario San Cecilio
Granada, , Spain
Hospital Universitario de Guadalajara
Guadalajara, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital General Universitario Morales Meseguer
Murcia, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Virgen de la Salud
Toledo, , Spain
Instituto Valenciano de Oncología
Valencia, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hospital Arnau Vilanova
Valencia, , Spain
Hospital Universitario Doctor Peset
Valencia, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Countries
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References
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de 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.
Liu 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.
Cejalvo 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.
Lluch 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.
Garcia-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.
Related Links
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Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group
Other Identifiers
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CONVERTHER/GEICAM 2009-03
Identifier Type: -
Identifier Source: org_study_id
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