AstraZeneca’s fulvestrant met its primary endpoint as first-line treatment in a Phase III trial for HR+ advanced breast cancer

AstraZeneca today announced positive results from the Phase III FALCON trial comparing fulvestrant 500mg to anastrozole 1mg for the treatment of locally-advanced or metastatic breast cancer, in postmenopausal women who have not had prior hormonal treatment for hormone receptor positive (HR+) breast cancer.1

Fulvestrant 500mg demonstrated superiority compared with anastrozole 1mg in FALCON, and met its primary endpoint of extended progression-free-survival. The trial showed an adverse event profile generally consistent with current knowledge of the safety profile of the medicines.1

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “The FALCON results bring us closer to offering more and earlier treatment options to postmenopausal women with HR+ locally-advanced or metastatic breast cancer; the potential to delay disease progression is important for these patients as there is currently no cure. Fulvestrant has over 10 years of clinical evidence and we are committed to exploring its potential along with the rest of our outstanding oncology portfolio.”

A full evaluation of the data is ongoing and the results are expected to be presented at a medical congress in 2016.

Aromatase inhibitors (such as anastrozole) are a standard of care in first-line treatment for postmenopausal women with advanced HR+ positive breast cancer.3,4,5


The FALCON (Fulvestrant and AnastrozoLCOmpared in hormonal therapy Naïve advanced breast cancer) study is a Phase III, randomised, double-blind, multicentre trial. The study compared the anti-tumour effects and tolerability profile of a 500mg dose of fulvestrant plus placebo with a 1 mg dose of anastrozole plus placebo, in postmenopausal women with hormone receptor-positive, locally advanced or metastatic breast cancer who have not been treated previously with any hormonal therapy.1

About Metastatic Breast Cancer (MBC)
MBC is the most advanced stage of breast cancer (stage IV), and occurs when cancer cells have spread beyond the initial tumor site to other parts of the body outside of the breast.6,7 Since there is no cure for metastatic breast cancer, the goal of current treatment is to delay disease progression.6,8

It is estimated that in 2016, there will be approximately 151,000 women in the US living with MBC, and this number is projected to increase to approximately 160,000 by the year 2020.9

About Fulvestrant
Fulvestrant is approved for the treatment of postmenopausal women with HR+ MBC whose cancer has progressed following antiestrogen therapy. On 2 March 2016, the US Food and Drug Administration (FDA) approved fulvestrant, in combination with palbociclib, for the treatment of US women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+, HER2-) advanced or metastatic breast cancer (MBC), whose cancer has progressed after endocrine therapy.2,10

Fulvestrant represents a hormonal therapy approach that targets the estrogen receptor (ER). The ER is a key driver of disease progression.11 Fulvestrant helps to slow tumor growth by blocking and degrading the ER.2

About Anastrozole
Anastrozole is approved for adjuvant treatment (treatment following surgery with or without radiation) of postmenopausal women with hormone receptor-positive early breast cancer. Anastrozole is approved for the initial treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer and for the treatment of postmenopausal women with advanced breast cancer that has progressed following treatment with tamoxifen. Patients with hormone receptor-negative disease and patients who did not previously respond to tamoxifen therapy rarely responded to anastrozole.4

About AstraZeneca in Oncology
Oncology is a therapeutic area in which AstraZeneca has deep-rooted heritage. It will be potentially transformational for the company’s future, becoming the sixth growth platform. Our vision is to help patients by redefining the cancer treatment paradigm and one-day eliminate cancer as cause of death. By 2020, we are aiming to bring six new cancer medicines to patients.

Our broad pipeline of next-generation medicines is focused on four main disease areas - ovarian, lung, breast, and haematological cancers. These are being targeted through four key platforms – immuno-oncology, the genetic drivers of cancer and resistance, DNA damage repair and antibody drug conjugates.  

About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as in infection and neuroscience. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit


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1. In House Data, AstraZeneca Pharmaceuticals LP. FALCON Clinical Study Protocol. 000-580-937. January 14, 2013

2. FASLODEX (fulvestrant) Prescribing Information. AstraZeneca Pharmaceuticals LP, Wilmington,DE

3. Rugo H. The breast cancer continuum in hormone-receptor-positive breast cancer in postmenopausal women: evolving management options focusing on aromatase inhibitors. Annals of Oncology. 2007;10.1093:1-12.

4. National Cancer Institute. Breast Cancer Treatment (PDQ®) Healthcare Professionals version. Available Online. Last Updated February 2, 2016. Last accessed May 18, 2016.

5. ARIMIDEX (anastrozole) Prescribing Information. AstraZeneca Pharmaceuticals LP, Wilmington, DE

6. American Cancer Society. What Is Advanced Cancer? Atlanta: American Cancer Society; 2014. Available online. Last accessed May 2016.

7. American Cancer Society. Bone Metastasis. Atlanta: American Cancer Society; 2014. Available online. Last accessed May 2016.

8. National Cancer Institute. Breast Cancer Treatment (PDQ®). Available Online. Last Updated September 25, 2014. Last accessed October 2014.

9. ONC-Prevalence of Metastatic Breast Cancer in Women 2014-2020. Available Online. Last accessed May 18, 2016.

10. FDA Approval Letter. U.S. Food and Drug Administration, Silver Spring, MD

11. Osborne et al. Mechanisms of Endocrine Resistance in Breast Cancer. Annu Rev Med. 2011; 62: 233–247.


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