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

Spanish Breast Cancer Research Group236 enrolled

Overview

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.

Population definition: Women previously diagnosed with a primary breast carcinoma who present locally recurrent or metastatic lesions and who meet the selection criteria. The expected sample size is 175 patients. 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

Study Type

OBSERVATIONAL

Enrollment

236

Conditions

Breast Cancer

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (32)

Outcomes

Primary Outcomes

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.

Time frame: 2 years since the beginning of the Study

Secondary Outcomes

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

To obtain the contingency table to calculate the probability of changes in ER and PR between different subtypes of primary breast cancers and their metastases.

Time frame: 2 years since beginning of the Study

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

The contingency table will compare the measurement between the local laboratory in relation to the central laboratory, for each of the HER2 receptor ER and PR (for these two last ones of joint form)

Time frame: 2 years since the beginning of the Study

Evaluate HER2 conversion rate compared to previously received treatment

For each of the types of treatment received will obtain the contingency table that allows to evaluate the conversion rate between the primary tumour HER2 and HER2 for metastases

Data from ClinicalTrials.gov

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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

...and 22 more locations