New combo trial hopes to tame advanced breast cancer
NCT ID NCT07427394
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 5 times
Summary
This study tests two experimental drugs, camizestrant and atirmociclib, in 24 people with a specific type of advanced breast cancer (ER-positive, HER2-negative) that has worsened after prior treatment. The main goal is to check safety and how the body processes the drugs, with early signs of tumor control also measured. This is not a cure; it aims to manage the disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2026
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Main Inclusion Criteria: * Participants with advanced adenocarcinoma of the breast and must have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease. * Metastatic or locoregionally recurrent disease and radiological or objective evidence of progression on or after the last systemic therapy prior to starting investigational medicinal products. * Eastern cooperative oncology group (ECOG)/World Health Organization (WHO) performance status 0 to 1, and a minimum life expectancy of 12 weeks. * At least one lesion that is measurable and/or non-measurable, as per RECIST 1.1 and that can be accurately assessed at baseline and is suitable for repeated assessment by computed tomography (CT), magnetic resonance imaging (MRI), or plain X-ray, or clinical examination. * Menopausal status * Pre-menopausal women must start GnRH agonist therapy at least 4 weeks before study treatment and continue throughout the study. * Post-menopausal women must meet one of these criteria: bilateral oophorectomy, age ≥60 years, age ≥50 years with ≥12 months amenorrhea and intact uterus without hormonal therapy, or age \<60 years with ≥12 months amenorrhea and post-menopausal hormone levels. * Histological or cytological confirmation of adenocarcinoma of the breast. * Participants of childbearing potential must agree to use one highly effective contraceptive measure. * Documentation of ER-positive tumor irrespective of progesterone receptor status. Main Exclusion Criteria: * A participant who has received 2 or more lines of CDK4/6 inhibitors in the advanced disease setting. * A participant who has received prior camizestrant or atirmociclib treatment in the advanced disease setting. * Patients previously treated with other next generation selective estrogen receptor degrader (SERDs) or other experimental ETs in the advanced disease setting. * Patients previously treated with other experimental cyclin-dependent kinase (CDK) inhibitors are not eligible. * Inability to swallow oral medications. * Any unresolved toxicities of Grade ≥ 2 from prior anti-cancer therapy (with the exception of alopecia). * Presence of life-threatening metastatic visceral disease. * Any evidence of severe or uncontrolled systemic diseases. * Contraindication to or known intolerance/hypersensitivity of/to camizestrant or atirmociclib.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced breast cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
6 sites in 2 countries. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Research Site
RECRUITINGSt Louis, Missouri, 63108, United States
-
Research Site
NOT_YET_RECRUITINGEast Providence, Rhode Island, 02915, United States
-
Research Site
RECRUITINGNashville, Tennessee, 37203, United States
-
Research Site
RECRUITINGCambridge, CB2 0QQ, United Kingdom
-
Research Site
RECRUITINGLondon, EC1M6BQ, United Kingdom
-
Research Site
RECRUITINGManchester, M20 4GJ, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new drug combo outsmart breast cancer that resists current therapy?
- Can a new tracer make tumors light up on scans?
- Can fasting and exercise beat cancer fatigue?
- CBD as a calming agent for Scan-Related anxiety in advanced breast cancer?
- Can a new pill tame advanced breast cancer?
- Can a Two-Step drug combo outsmart advanced HER2-Positive breast cancer?