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Contact Information:

Sermonix Pharmaceuticals Study Inquiry 614-864-4919
info@sermonixpharma.com


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Be Part of Research - Trial Details - Evaluation of Lasofoxifene Combined with Abemaciclib Compared with Fulvestrant Combined with Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer with an ESR1 Mutation
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Evaluation of Lasofoxifene Combined with Abemaciclib Compared with Fulvestrant Combined with Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer with an ESR1 Mutation

Recruiting

Open to: ALL

Age: 18.0 - N/A

Manchester Nottingham London Leeds

Medical Conditions

Breast Neoplasms

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation.

The main question the study aims to answer is:

• To compare the efficacy of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Oct 2023 Apr 2027

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day

Intervention Arm Group : Treatment;

Intervention Type : DRUG
Intervention Description : Fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day

Intervention Arm Group : Reference Therapy;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Christie NHS Foundation Trust
    Manchester
  • Nottingham City Hospital
    Nottingham
  • Charing Cross Hospital
    London
  • Leeds Teaching Hospitals NHS Trust
    Leeds

Sermonix Pharmaceuticals Study Inquiry 614-864-4919
info@sermonixpharma.com



The study is sponsored by Sermonix Pharmaceuticals Inc.



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Read full details for Trial ID: NCT05696626
Last updated 21 February 2025

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