What is Clinical Research?

It is through clinical research that medicine evolves. Research is essential so that we can learn more about diseases, develop new drugs, vaccines, and tests.

Research generating knowledge and saving lives

A cure for cancer is also in research. But to do so, it is necessary to overcome many challenges, including: funding, awareness, regulation, and encouragement of scientific production. The researchers attribute the notable advances to advances in areas such as cancer research, prevention, detection, diagnosis, and treatment. In addition, they highlight the revolution that has taken place in immune therapies, which, together with chemotherapy and radiotherapy, contribute to extending patients' lives.

Homem e mulher sentados em uma sala de espera de consultório oncológico.
Uma mulher em roupas de enfermeira escreve em um papel.

The impact of research in the fight against cancer

Currently, Brazil participates in only 2% of the studies, globally. Adding the other countries together, Latin America participates in only 5% of ongoing oncology trials, and 90% of clinical trials in the region are funded by the pharmaceutical industry. The industry carries out important research, but it is not enough, in addition to the fact that many of them have objectives that are different from those that we really need to carry out.
Clinical trials can help to make better use of medical treatment, maintaining the integrity and quality of life of patients during this sensitive period. Without this qualified participation, we risk seeing new drugs being introduced in our country without oncologists having any experience of the impacts on their effective use.

The stages of clinical cancer research in Brazil

Preclinical Phase

Conducted in a laboratory. Before being tested on humans, the drug undergoes several phases of study where its efficacy and safety are evaluated.

Phase 1

The safety of the drug in humans is evaluated, so few patients, generally healthy, participate in the highly monitored studies (it takes a few months).

Phase 2

The safety of the drug is re-evaluated and the first evaluation of the efficacy of the drug in the fight against the disease is also carried out. It involves a larger population that has the disease. It lasts, on average, 2 to 3 years

Phase 3

The studies are larger and more complex to confirm efficacy, tolerability, and safety of the investigational drug. Therefore, it is performed with a much larger group of patients. The drug is compared with standard therapy. At this stage, the necessary information is obtained to prepare the drug label and package insert. It can extend from 2 to 10 years.

Phase 4

Performed after the drug has been registered and used in the clinical routine, that is, it is already marketed. These are observational studies to obtain various information, such as the appearance of new adverse reactions or confirmation of already known reactions. It involves thousands of patients.

STUDIES

Recruitment research

LACOG 0419 – NEOSAMBA
Evaluation of anthracycline and taxane sequencing for locally advanced HER2-negative breast cancer

Primary objectives: To evaluate in a phase III randomized clinical trial the comparison between an anthracycline-initiated neoadjuvant chemotherapy (AC-T) versus a taxane-initiated (T-AC) regimen in patients with locally advanced HER2 breast cancer

LACOG 0821 – AMIGO-1
A single-arm phase 2 study of amivantamab, lazertinib, and pemetrexed for first-line treatment of recurrent/metastatic non-small cell lung cancers (NSCLCs) with EGFR mutations

Primary objectives: To evaluate in a phase III randomized clinical trial the comparison between an anthracycline-initiated neoadjuvant chemotherapy (AC-T) versus a taxane-initiated (T-AC) regimen in patients with locally advanced HER2 breast cancer

LACOG 0522 – DORA
DORA Trial: Phase III Trial of Docetaxel vs. Docetaxel and Radio-223 for Castration-Resistant Metastatic Prostate Cancer (mCRPC)

Primary objectives: To compare overall survival for individuals treated with docetaxel versus individuals treated with docetaxel plus Radio-223.

LACOG 0322 – EDUR-BRA
A real-world assessment of the demographic, clinical characteristics, and outcomes of a Brazilian cohort of previously untreated extended-stage small cell lung cancer receiving Durvalumab combined with platinum etoposide (ES-SCLC) in Brazil.

Primary objectives: To describe the demographic and clinical characteristics of a real-world cohort of Brazilian patients diagnosed with ES-SCLC treated with durvalumab-based regimens.

LACOG 0222 – GASPAR
Epidemiological characteristics of gastric and pancreatic cancers in Latin America

Primary objectives: To describe the clinical characteristics, treatment patterns, and outcomes of patients with pancreatic, gastric, and gastroesophageal junction cancer in Latin America

LACOG 0421 ACTION HIV
ACTION HIV (Anal Cancer Therapies and Outcomes initiative for patients living with and without HIV): A global registry of patients with anal squamous cell carcinoma with and without HIV infection.

Describe the epidemiological characteristics and prognostic factors for disease-free survival of patients with CC with and without HIV infection.

LACOG 0521 – MADONA
Molecular and epidemiological characteristics of endometrial cancer in Brazil

Primary objectives: To describe epidemiological characteristics, molecular profile, treatment patterns, and outcomes of endometrial cancer in a Brazilian population

LACOG 0122 RADIANT
Radiotherapy with extreme hypofractionation in patients with breast cancer in Brazil: a retrospective cohort study

Primary objectives: To evaluate the efficacy of the extreme hypofractionation scheme, in 5 fractions of 5.2 Gy, in women with breast cancer.

LACOG 0721 CHERRY-PICK
HER2 dependence classification to decrease neoadjuvant chemotherapy in patients with early HER2+ breast cancer undergoing double HER2 blockade

Primary objectives: To evaluate the pCR rate in participants with HER2-positive early breast cancer selected for high dependence on the HER2 pathway and treated with neoadjuvant PHESGO without chemotherapy; who demonstrate a favorable PET-CT response after the third cycle of therapy.

LACOG 1220 – CONOR
CONOR: A collaborative trial of Nirparib to evaluate patients with ovarian cancer in the expanded access program in Latin America

Primary objectives: To evaluate the safety profile, including dose modifications, of nirparib in patients with advanced ovarian cancer in response after platinum-based first-line chemotherapy treated in a real-world environment within the EAP.

Uma mulher com lenço na cabeça está sentada à mesa com outra mulher segurando a sua mão.

Como participar de uma pesquisa clínica?

Informe-se se tem algum estudo clínico aberto que contemple as características da sua doença. Cada estudo possui critérios de inclusão diferentes. Converse com seu médico para saber se, no momento, há algum tratamento disponível através de estudo clínico que poderia ajudar no seu caso. Existem algumas plataformas, sites e perfis de divulgação de pesquisas. O @projetocura, o @lacogcancerresearch e o @pesquisaclinicacancer sempre divulgam estudos abertos.

Did you find a study?

Get in touch and the medical researchers will assess whether your disease is compatible with the research that will be carried out, and all the risks and benefits of the treatment. If so, you will be informed of all the details and will be part of a treatment group and become a volunteer. Each group receives different treatments, which may include the treatment under investigation (new drug), or standard treatment, or even the receipt of a placebo (product without active medication, without harm to the volunteer).

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