Mapping breast and prostate cancer in Brazil's public health system
Onco-Genomas Brasil: Mapping Breast and Prostate Cancer in the Brazilian Public Health System
This study is trying to understand how breast and prostate cancer works in Brazilian patients by looking at their genes and family backgrounds to help improve treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 882 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Moinhos de Vento Academic / other |
| Drugs / interventions | trastuzumab, chemotherapy, immunotherapy, doxorubicin |
| Locations | 25 sites (Manaus, Amazonas and 24 other locations) |
| Trial ID | NCT05306600 on ClinicalTrials.gov |
What this trial studies
This project aims to perform complete sequencing of the somatic and germline exomes of cancer patients treated through the Brazilian Unified Health System. It focuses on generating genomic and phenotypic data to support the National Precision Genomics and Health Program, Genomas Brasil. The study will also collect data on the population's ancestry, which is crucial for understanding the molecular variants in tumors that can influence treatment response and disease prognosis.
Who should consider this trial
Good fit: Ideal candidates include Brazilian women aged 18 and older with confirmed HER2-positive or triple-negative breast carcinoma at clinical stages II or III.
Not a fit: Patients with breast cancer who do not meet the specified eligibility criteria or those with other types of cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance personalized treatment strategies for breast and prostate cancer patients in Brazil.
How similar studies have performed: Other studies focusing on genomic mapping in cancer have shown promise, indicating that this approach could yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria for breast cancer patients (Arm 1): * Women aged ≥ 18 years; * Brazilian nationality; * After review at the Hospital Moinhos de Vento, confirmed histological diagnosis of breast carcinoma with overexpression of HER2 (classified by immunohistochemistry as 3+ or 2+ with positive in-situ hybridization) or triple-negative (estrogen and progesterone receptors \<1% and no overexpression of HER2); * Clinical stage II or III for HER2-positive and I, II and III for triple-negative patients - American Joint Committee on Cancer (AJCC) 8th edition; * HER2- positive patients: must undergo neoadjuvant chemotherapy plus trastuzumab in the following regimens: anthracycline (doxorubicin or epirubicin) followed by taxane (docetaxel or paclitaxel), combined with trastuzumab, or a non-anthracycline option consisting of taxane (docetaxel or paclitaxel) combined with carboplatin and trastuzumab; * Triple-negative patients: must undergo neoadjuvant chemotherapy without immunotherapy in the following regimens: anthracycline (doxorubicin or epirubicin) followed by taxane (docetaxel or paclitaxel) with/ without platins (carboplatin ou cisplatin) or a regimen without anthracycline (taxane with/without platins) * Patients must provide written informed consent prior to inclusion Inclusion criteria for patients with prostate cancer (Arm 2): * Men aged ≥ 18 years; * Confirmed histological diagnosis of prostate adenocarcinoma; * AJCC 8th edition clinical stage IV; * Patients must provide written informed consent. Exclusion criteria for Arms 1 and 2: * No available paraffin-embedded tumor tissue for genomic analysis; * Inability to collect blood for genomic evaluation.
Where this trial is running
Manaus, Amazonas and 24 other locations
- Fundação Centro de Controle de Oncologia do Estado do Amazonas — Manaus, Amazonas, Brazil (Recruiting)
- Hospital Universitário Getúlio Vargas — Manaus, Amazonas, Brazil (Recruiting)
- Hospital Santa Rita de Cássia - AFECC — Vitória, Espírito Santo, Brazil (Recruiting)
- Hospital Calixto Midlej Filho/ Santa Casa de Itabuna — Itabuna, Estado de Bahia, Brazil (Recruiting)
- Serviço de Assistência Médica e Urgência S.A. SAMUR — Vitória da Conquista, Estado de Bahia, Brazil (Recruiting)
- Hospital Universitário de Brasília — Brasília, Federal District, Brazil (Recruiting)
- Hospital do Câncer do Maranhão — São Luís, Maranhão, Brazil (Recruiting)
- Hospital da Santa Casa de Misericórdia — Belo Horizonte, Minas Gerais, Brazil (Recruiting)
- Hospital das Clínicas — Belo Horizonte, Minas Gerais, Brazil (Recruiting)
- Hospital do Câncer/União Oeste Paranaense de Estudo e Combate ao Câncer — Cascavel, Paraná, Brazil (Recruiting)
- Hospital do Câncer de Londrina — Londrina, Paraná, Brazil (Recruiting)
- Hospital Ophir Loyola — Belém, Pará, Brazil (Recruiting)
- Hospital Universitário João de Barros Barreto — Belém, Pará, Brazil (Recruiting)
- Liga Norte Riograndense Contra o Câncer — Natal, Rio Grande do Norte, Brazil (Recruiting)
- Hospital Escola da Universidade Federal de Pelotas — Pelotas, Rio Grande do Sul, Brazil (Recruiting)
- Hospital do Amor — Barretos, São Paulo, Brazil (Recruiting)
- Hospital Universitário Maria Aparecida Pedrossian — Campo Grande, Brazil (Recruiting)
- Hospital Araújo Jorge — Goiânia, Brazil (Recruiting)
- Hospital de Clínicas de Porto Alegre — Porto Alegre, Brazil (Recruiting)
- Hospital São Lucas da PUCRS — Porto Alegre, Brazil (Recruiting)
- Grupo Hospitalar Conceição — Porto Alegre, Brazil (Recruiting)
- Hospital Fêmina — Porto Alegre, Brazil (Recruiting)
- Instituto Nacional do Câncer (INCA) — Rio de Janeiro, Brazil (Recruiting)
- Hospital São Camilo — São Paulo, Brazil (Recruiting)
- Hospital Universitário Cassiano Antônio de Moraes — Vitória, Brazil (Recruiting)
Study contacts
- Principal investigator: Daniela D Rosa, PhD — Hospital Moinhos de Vento
- Study coordinator: Marina Bessel
- Email: marina.bessel@hmv.org.br
- Phone: +555135378345
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.