Breast Cancer: Alisertib with Hormone Therapy

We are studying how well alisertib works with hormone therapy for patients with recurrent or metastatic hormone receptor positive, HER2 negative breast cancer. Our goal is to find the best dose and assess safety and effectiveness.

What diseases are being studied?

Health conditions and diseases that the clinical trial is designed to study and treat.

Who can participate in the clinical trial?

These questions help us understand your situation so we can let the trial team know whether you might be a potential match. This is not a medical evaluation and is not part of the official screening, the study doctor will make the final decision..

What medicines are being studied?

Medicines that are officially approved for use in the European Union and considered safe by EMA. These medicines are already on the market and may be tested for new conditions or populations.

Anastrozole Accord
Anastrozole Accord is a medicine used to treat certain types of breast cancer in postmenopausal women.
Exemestane Sanoswiss
Exemestane Sanoswiss is a medicine used to treat breast cancer in postmenopausal women by lowering estrogen.
Fulvestrant Stada Arzneimittel
Fulvestrant Stada Arzneimittel is a medicine used to treat certain types of advanced breast cancer that depend on hormones.

What active substances are being studied?

Active substances that are officially approved for use in the European Union and considered safe by EMA. These substances are already on the market and may be tested for new conditions or populations.

Anastrozole
Anastrozole is a substance that lowers estrogen levels to help treat and prevent hormone-sensitive breast cancer in postmenopausal women.
Exemestane
Exemestane is a substance that lowers estrogen levels to help treat hormone-sensitive breast cancer in postmenopausal women.
Fulvestrant
Fulvestrant blocks and destroys estrogen receptors to treat hormone receptor–positive breast cancer.

What experimental substances are being tested?

Experimental substances that are being investigated in this clinical trial. These are not yet approved for general use.

Alisertib

What similar medicines might you know?

Don't worry if you don't know the medicines tested in the trial. There is a chance you have heard about the similar medicines. Check the list below to see if you are familiar with any of them.

Adifen 10mg
Adiunastrol
Afultrant

Where is the clinical trial being conducted?

Locations and medical facilities where this clinical trial is currently recruiting or conducting research. Select the locations where you would like to participate.

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Champalimaud Clinical Centre
Oncology
Belém, Portugal
Hospital Cuf Descobertas S.A.
Oncology
Cabo Ruivo, Portugal
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Oncology
Paranhos, Portugal

Sponsor: Puma Biotechnology Inc.
Last updated: Nov 27, 2025

Disclaimer: Parts of this content have been automatically extracted from the EU Clinical Trials registry. While we strive for accuracy, please always contact the trial site or sponsor directly for correct and official information before making any decisions about participation. View on EU Clinical Trials.