Testing MEN2312 in adults with advanced breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human trial evaluating MEN2312, a KAT6 inhibitor, in adults suffering from advanced breast cancer that cannot be cured. Participants must have previously undergone at least one line of endocrine therapy and have shown progression on specific treatments. The study aims to assess the safety and efficacy of MEN2312 in this patient population. Additionally, Elacestrant will be administered as part of the treatment regimen.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Participant has advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.
* Presence of genetic alterations in PIK3CA/AKT1/PTEN in participants' tumor tissue.
* Participant must have received at least 1 prior line of endocrine therapy for advanced/metastatic disease or participant who has radiological evidence of breast cancer recurrence or progression during or within 12 months from the end of adjuvant treatment with endocrine therapy, as these participants are considered as first-line relapsed participants.
* Progression on previous cyclin-dependent kinase 4 and 6 inhibitor treatment in combination with fulvestrant or aromatase inhibitor is required.

Key Exclusion Criteria:

* Active or newly diagnosed central nervous system metastases.
* Participants with advanced, symptomatic visceral spread, who are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis, or liver involvement \>50%.
* Participants with any toxicities related to prior radiation therapy that have not resolved to baseline or to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 Grade ≤1, except alopecia and peripheral sensory neuropathy (Grade ≤2).

Note: Other inclusion/exclusion criteria may apply.

Where it's running

• Highlands Oncology Group
  Springdale, Arkansas, United States Recruiting
• City of Hope
  Duarte, California, United States Recruiting
• UC San Diego Moores Cancer Center
  La Jolla, California, United States Recruiting
• Stanford Cancer Center
  Palo Alto, California, United States Recruiting
• UCSF Helen Diller Family Comprehensive Cancer Center
  San Francisco, California, United States Recruiting
• UCLA Hematology Oncology - Parkside
  Santa Monica, California, United States Recruiting

Study contacts

• Study coordinator: Stemline Trials
• Email: clinicaltrials@menarinistemline.com
• Phone: 1-877-332-7961

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Imaging study of [68Ga]Ga-DWJ155 in adults with solid tumors

  This trial tests a new radioligand imaging agent, [68Ga]Ga-DWJ155, to see how well it images tumors and how safe it is in adults with advanced solid cancers.

  Recruiting at 2 sites Phase 1 Novartis · Darlinghurst, New South Wales and 1 other locations · NCT07801508

• T-DXd–based therapy followed by targeted HER2 blockade and endocrine therapy in first-line HER2+ / HR+ metastatic breast cancer

  This trial tests a sequence of therapies starting with T-DXd plus pertuzumab, then a maintenance phase with dual HER2 blockade, endocrine therapy, and CDK4/6 inhibitor, with a retreatment option of T-DXd if disease progresses.

  Recruiting at 5 sites Phase 3 Daiichi Sankyo · Columbia, Maryland and 4 other locations · NCT07683754

• Timing ctDNA Testing to Guide Treatment in Advanced Breast Cancer

  This study tests how ctDNA levels and key gene mutations relate to outcomes and treatment responses in adults with advanced breast cancer.

  Recruiting Geneplus-Beijing Co. Ltd. · Beijing · NCT07681323

• Decision Support Tool for People with Advanced Breast Cancer

  This study tests a decision support tool called COAST to help people with stage IV breast cancer talk with their doctors and share treatment preferences.

  Recruiting at 3 sites Weill Medical College of Cornell University · Brooklyn, New York and 2 other locations · NCT07635147

• Metronomic Oral Paclitaxel for Advanced HER2-Negative Breast Cancer

  This study tests whether low, regular doses of an oral paclitaxel solution can be safely used to control tumor growth in adults with advanced HER2-negative breast cancer who have already had prior cancer therapy.

  Recruiting Phase 2 Zhejiang Cancer Hospital · Hangzhou, Zhejiang · NCT07602907

• Pyrotinib-based regimens for advanced HER2-positive breast cancer: real-world sequential therapy after progression

  This real-world study tests whether giving disitamab vedotin after pyrotinib-based treatment helps people with advanced HER2-positive breast cancer.

  Recruiting Phase 4 Peking University People's Hospital · Beijing, Beijing Municipality · NCT07600164

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.