Evaluation of Degree of Conversion of HER2 Receptor Between Primary Breast Cancer and Metastasis

NCT01377363 | Completed

• 1 other identifier: CONVERTHER/GEICAM 2009-03
• Study Type: observational
• Target: 236
• Locations: 1 country
• Sites: 32

Brief Summary

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

Breast Cancer

Keywords

metastatic breast cancer; primary breast cancer

Outcome Measures

Primary Outcomes (1)

• Evaluation of degree of conversion of human epidermal growth factor receptor 2 (HER2) receptor between primary breast cancer and metastases

  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.

  2 years since the beginning of the Study

Secondary Outcomes (10)

• To determine the probability of changes in ER and PR between different subtypes of primary breast cancer and their metastases

  2 years since beginning of the Study

• Analyze the variability in the measurement of HER2, ER and PR between local laboratories and central laboratory

  2 years since the beginning of the Study

• Evaluate HER2 conversion rate compared to previously received treatment

  2 years since the beginning of the Study

• Evaluate whether the location of biopsied metastases relates to the probability of conversion of HER2.

  2 years since the beginning of the Study

• Compare the disease-free survival (DFS) and survival post relapse (SPR) of patients with or without conversion of HER2 and ER/PR

  2 years since the beginning of the Study

Study Arms (1)

Not treatment

Locally recurrent breast carcinoma or metastatic

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients diagnosed of primary breast carcinoma with locally recurrent breast carcinoma or metastasic

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spanish Breast Cancer Research Group: lead
• Roche Farma, S.A: collaborator

Study Sites (32)

Hospital Virgen de los Lirios

Alcoy, Alicante, 03804, Spain

Location

Hospital General de Elda

Elda, Alicante, 03600, Spain

Location

Hospital de Son Llàtzer

Palma de Mallorca, Balearic Islands, 07198, Spain

Location

Althaia Xarxa Asistencial de Manresa

Manresa, Barcelona, 08243, Spain

Location

Consorcio Hospitalario Provincial de Castellón

Castellon, Castellón, 12002, Spain

Location

Hospital Punta de Europa

Algeciras, Cádiz, 11207, Spain

Location

Hospital Jerez de la Frontera

Jerez de la Frontera, Cádiz, 11407, Spain

Location

Complejo Hospitalario Universitario de A Coruña

A Coruña, La Coruña, 15006, Spain

Location

Hospital Materno Insular de Canarias

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

Location

Fundación Hospital Alcorcón

Alcorcón, Madrid, 28922, Spain

Location

Hospital Universitario Severo Ochoa

Leganés, Madrid, 28911, Spain

Location

Hospital Universitario Quirón salud Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Tenerife, 38010, Spain

Location

Hospital de Sagunto

Sagunto, Valencia, 46520, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital San Pedro de Alcantara

Cáceres, 10003, Spain

Location

Hospital Universitari de Girona Doctor Josep Trueta

Girona, 17007, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital Universitario San Cecilio

Granada, 18016, Spain

Location

Hospital Universitario de Guadalajara

Guadalajara, 19002, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital General Universitario Morales Meseguer

Murcia, 30008, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Virgen de la Salud

Toledo, 45004, Spain

Location

Instituto Valenciano de Oncología

Valencia, 46009, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Arnau Vilanova

Valencia, 46015, Spain

Location

Hospital Universitario Doctor Peset

Valencia, 46017, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, 46026, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Related Publications (5)

• 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.

  PMID: 24414130 RESULT

• 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.

  PMID: 31388936 RESULT

• 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.

  PMID: 28249905 RESULT

• 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.

  PMID: 31491604 RESULT

• 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.

  PMID: 32573490 RESULT

Related Links

• Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group

Biospecimen

Retention: SAMPLES WITHOUT DNA

Primary tumor sample and metastasis sample

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Study Director

  Hospital Clinico Universitario de Valencia

  STUDY DIRECTOR

• Study Director

  Consorcio Hospitalario Provincial de Castellon

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: June 21, 2011
• Study Start: December 11, 2009
• Primary Completion: November 30, 2012
• Study Completion: November 30, 2012
• Last Updated: March 10, 2023

Record last verified: 2023-03

Locations

ES (32)