March 1, 2019by HLF0


Contact: Dr. Atara Ntekim
Department of Radiation Oncology
University of Ibadan/ University College Hospital Ibadan
Email: antekim@com.ui.edu.ng

Monday, July 29, 2019

Four Nigerian Tertiary Hospitals, University of Chicago Medicine and Hoffman-LaRoche Pharmaceutical Company Collaborate on Groundbreaking Breast Cancer Clinical Trial

Largest cancer genomics study of women of African ancestry previously highlighted molecular features that could be targeted to reduce the high breast cancer mortality among Nigerian women. Today, the team unveils the 1st Oncology Clinical Trial to target genomic abnormalities in breast cancer

A new study comparing DNA and RNA data from Nigerian breast cancer patients to patients in a United States database found that aggressive molecular features were far more prevalent in tumors from women of African ancestry than women of European ancestry. Those differences in part explain the high breast cancer mortality for Nigerian women and hastened a shift to precisely targeted therapies. Today, in collaboration with University of Chicago Medicine, USA and F. Hoffmann-La Roche Ltd (Roche), Switzerland, Nigerian team of investigators from UCH, Ibadan, LUTH, Lagos, LASUTH, Lagos and OAUTH unveil the 1st oncology clinical trial entitled “Assessing the REsponse rate of neoadjuvant Taxotere and TrastuzumAb in Nigerian women with HER2-positive breast cancer (ARETTA). By gaining early access to this highly innovative oncology clinical trial, more lives of Nigerian patients with HER2 positive breast cancer patients will be saved and more knowledge will be created to find new cures for the future.

In the past, the practice of medicine advanced by trial and error. Older doctors simply passed on their knowledge and experience to younger doctors. For the most part, this way of teaching and learning worked well. Over the years, medical care improved. At the same time, however, this trial-and-error approach meant some medical practices did not work well, and others were dangerous. Clinical trials have been found to be the best way to make sure new standards of medical care are, in fact, safe and effective. This is especially true for new drugs, devices, or procedures. Successful cancer treatment could not be done today were it not for clinical trials.

What is a clinical trial?
A clinical trial is a study that helps test whether a new treatment or medication is safe and effective. Or it can look to see which older treatments produce the best results. In cancer treatments, previous studies have been very important in finding the best way to care for patients. More trials are needed to see if newer approaches might produce even better results.

A study comparing DNA and RNA data from Nigerian breast cancer patients to patients in a United States database found that certain aggressive molecular features were far more prevalent in tumors from Nigerian women than in black or white American women. One of the most frequently mutated genes in Nigerian women with breast cancer is human epidermal growth factor receptor 2 (HER2), for which there are highly effective but very expensive therapies. “Nigerian women,” Dr. Atara Ntekim, a Nigerian Oncologist and leader of the study team, said, “should be provided access to HER2 targeted therapies. Our team has worked tirelessly over the past three years to bring the 1st oncology targeted therapy clinical trial to Nigeria. With successful implementation of this trial, we plan to use our rapidly growing network of medical oncologists to expand to other cancer types and bring safe administration of highly effective cancer medicines to other regions of the country.”

In a transnational collaboration to establish a platform for Oncology Clinical Trials in Nigeria and across Sub-Saharan Africa, researchers from four tertiary hospitals affiliated with the Universities of Ibadan, University of Lagos, Obafemi Awolowo University and Lagos State University worked in partnership with the University of Chicago and Roche to develop a protocol for Nigerian women with aggressive HER2 positive breast cancer that is potentially curable with novel therapies.

“In the era of precision medicine ARETTA will provide insights that could reduce the number of deaths from breast cancer across Sub-Saharan Africa and the developing world,” said study Sponsor, Olufunmilayo Olopade, MD, the Walter L. Palmer Distinguished Service Professor of Medicine and Human Genetics, associate dean for Global Health and director of the Center for Clinical Cancer Genetics at the University of Chicago Medicine.

The primary objective of ARRETA is to test the efficacy and toxicity of docetaxel chemotherapy and HER2 blockage with subcutaneous Herceptin administered every three weeks in Nigerian women with HER2-positive breast cancer. The study plans to enroll 60 patients newly diagnosed with early stage, non-metastatic breast cancer who have not received any prior treatment before enrollment. Patients will receive treatment before surgery to remove the breast cancer to examine whether the tumor will simply melt away with docetaxel in combination with Herceptin. For those not responding quickly, they will receive additional standard chemotherapy. The study will also test the side effects and quality of life of women undergoing treatment because it is important to also understand how to best support women as they go through cancer treatments.

Breast cancer rates are increasing in Nigeria and across Sub-Saharan Africa at an alarming pace without the necessary infrastructure to stem the epidemic. “Without local cancer experts who can develop investigator initiated oncology clinical trials to improve quality of cancer care, we cannot reduce premature deaths from cancer,” says Prof Peace Babalola, Vice Chancellor Chrisland University, Abeokuta, Nigeria, Professor of Pharmaceutical Chemistry/Pharmacokinetics and former Dean, Faculty of Pharmacy, University of Ibadan. “Understanding how to tailor treatment of breast cancer with the least amount of side effects is one of the most fundamental questions remaining in breast cancer research, and is a crucial first step toward developing a cost effective approach that Nigerians need”

While tumors from Nigerian women were frequently characterized by “molecular features of aggressive disease,” said Olusola Olopade, MD, a leading Clinical Researcher and Director of International programs at Pritzker School of Medicine, University of Chicago. “lack of well-trained physicians to conduct oncology clinical trials in Nigeria has prevented populations of African ancestry from benefiting from advances in cancer research. While every physician is potentially capable of participating in clinical trials, very few are qualified to handle novel highly effective and less toxic targeted cancer medicines. University of Chicago is proud to be able to participate in building the capacity of doctors in Nigeria to conduct oncology clinical trials”

The study, according to the interdisciplinary team of doctors, nurses, pharmacists, laboratory scientists and social workers , “builds a platform for us to learn how to help our patients gain access to genomically-tailored and potentially life-saving cancer medicines,” they add.

ARETTA study is supported by the National Cancer Institute, Breast Cancer Research Foundation, Roche and the Kiphart Family Foundation.

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