Onco-Genomas Brasil: Mapping Breast and Prostate Cancer in the Brazilian Public Health System

Plain-language summary

This study aims to map the genetic characteristics of breast cancer and prostate cancer patients in the Brazilian public health system, using whole exome and whole genome sequencing analyses. It enrolls women over 18 with HER2-positive or triple-negative breast cancer, and men with advanced-stage prostate adenocarcinoma. This is a study without a phase and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

Hospital Moinhos de Vento

Intervention

whole exome and whole genome sequencing analysis

Start date

11/9/2022

Estimated completion

12/31/2026

Countries

Brazil

Related genes

Locations

• Manaus, Brazil
• Manaus, Brazil
• Vitória, Brazil
• Itabuna, Brazil
• Vitória da Conquista, Brazil
• Brasília, Brazil
• São Luís, Brazil
• Belo Horizonte, Brazil
• Belo Horizonte, Brazil
• Cascavel, Brazil
• Londrina, Brazil
• Belém, Brazil
• Belém, Brazil
• Natal, Brazil
• Pelotas, Brazil
• Barretos, Brazil
• Campo Grande, Brazil
• Goiânia, Brazil
• Porto Alegre, Brazil
• Porto Alegre, Brazil
• Porto Alegre, Brazil
• Porto Alegre, Brazil
• Rio de Janeiro, Brazil
• São Paulo, Brazil
• Vitória, Brazil

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.