Team Successfully Completes Fisrt [sic] Clinical Trial on HER-2-Negative Breast Cancer with Nintedanib

The gist: People with early-stage HER-2-negative breast cancer might benefit from a new drug called nintedanib combined with standard chemotherapy. That insight came from a recently completed clinical trial—a research study with volunteer patients. 50% of the patients who took the new treatment in the trial had total remission of their tumors.

“The experimental drug nintedanib, combined with standard chemotherapy with paclitaxel, causes a total remission of tumours in 50% of patients suffering from early HER-2- negative breast cancer, the most common type of breast cancer. These are the conclusions of the Phase I Clinical Trial, sponsored by the Spanish National Cancer Research Centre (CNIO) and carried out by CNIO ́s Breast Cancer Clinical Research Unit. The study has been published today in British Journal of Cancer.

“According to Miguel Ángel Quintela, head of the Unit: ‘The drug combination of paclitaxel and nintedanib has turned out to be a complete success, given that it is proved to be safe and that the pathologic complete response [rate of complete recovery] was 50%, which doubles the response compared to patients treated with standard therapy with paclitaxel.’ The trial has also included 10 HER-2-negative breast cancer patients, all of them in early stages of the disease.

“In light of the results, the CNIO Breast Cancer Clinical Research Unit has already launched a large-scale Phase II Clinical Trial to validate the results in a large group of patients. These results, including biomarker studies that will facilitate advances in personalised medicine, will be released by early 2015.”


Everolimus Plus Exemestane Extended PFS in Invasive Lobular Carcinoma

The gist: This article discusses the results of a clinical trial—a research study with volunteer patients. The trial tested a new treatment for patients with advanced, HR-positive, HER-2-negative invasive lobular carcinoma. The new treatment combines the drugs everolimus and exemestane. The researchers found that it significantly prolonged the amount of time patients lived without their cancer worsening.

“The addition of everolimus to exemestane significantly prolonged PFS in a subset of patients with HR-positive, HER-2–negative advanced breast cancer who had invasive lobular carcinoma at baseline, according to a subanalysis of the BOLERO-2 trial presented at the Breast Cancer Symposium.

“Gabriel N. Hortobagyi, MD, FACP, professor of medicine in the department of breast medical oncology at The University of Texas MD Anderson Cancer Center, and colleagues evaluated data from 104 patients with invasive lobular carcinoma. The cohort included patients with predominantly peritoneal, gastrointestinal and ovarian metastases.

“Patients received exemestane (Aromasin, Pfizer) with everolimus (Afinitor, Novartis; n=64) or placebo (n=40).

“The median age of the patients was 63 years, and 47.1% had measurable disease. Thirty-six percent of patients had visceral metastases of the lung, liver, pleural and peritoneum; 10% had lung metastases; and 23% had liver metastases.”