Pharmaceutical company AstraZeneca Plc (AZN) said Thursday revealed positive data from a Phase III Confirm study of postmenopausal women with hormone receptor-positive advanced breast cancer. The study showed that Faslodex, or fulvestrant 500 mg, reduced the risk of disease progression compared with Faslodex 250 mg, the dose currently approved by the U.S. Food and Drug Administration.
Confirm or Comparison of Faslodex In Recurrent or Metastatic breast cancer study is a double-blind, double-dummy study with primary objectives to compare efficacy, as measured by time to progression of fulvestrant 500 mg with the approved 250-mg dose. Secondary objectives of the study included objective response rate, clinical benefit rate duration of clinical benefit, overall survival and quality of life. Safety and tolerability were also assessed in the study.
The Confirm study data showed that fulvestrant 500 mg significantly prolonged time to progression compared to fulvestrant 250 mg, with a median time to progression of 6.5 months at 500 mg dose compared with a median time to progression of 5.5 months with 250 mg dose. The study also showed a non-significant 16% reduction in the risk of death for patients receiving fulvestrant 500 mg compared with fulvestrant 250 mg.
Time to progression is a measure of time after a disease is diagnosed or treated until the disease starts to get worse.
Commenting on the results Angelo Di Leo, Head of Sandro Pitigliani Medical Oncology Unit, Hospital of Prato, Italy, and Confirm principal investigator said, "Findings from CONFIRM provide additional data showing that increasing the dose of fulvestrant from 250 mg to 500 mg may improve the effectiveness of a currently available treatment option to help maintain disease control longer -- a primary objective of treatment for women with metastatic breast cancer."
The most common side effects related to the use of the drug included nausea, bone pain, back pain and injection site pain. Regarding safety, the company said that no new concerns were identified with the drug on 500 mg dose.
Separately, Pfizer (PFE) presented its updated trial results from Intergroup Exemestane Study and the Tamoxifen, Exemestane, Adjuvant, Multicenter study for its breast cancer drug Aromasin.
According to the data presented by Pfizer, postmenopausal women who switched to Aromasin after 2.5 years of tamoxifen experienced a 19% reduction in risk of breast cancer recurrence compared to women who continued on tamoxifen for a full five years of treatment. However, other study, Tamoxifen, Exemestane, Adjuvant, Multicenter study did not show a difference in disease free survival in women who took Aromasin for five years compared to those who switched from tamoxifen to Aromasin after two to three years.
Thursday, AZN closed at US$45.35, unchanged from its previous trading session closing price on a volume of 1.70 million shares on NYSE. The stock closed unchanged from its previous trading closing of 2,796 pence on a volume of 3.23 million shares on London Stock Exchange.
For comments and feedback contact: editorial@rttnews.com
June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.