124 Participants Needed

MEN2312 for Breast Cancer

Recruiting at 38 trial locations
ST
Overseen ByStemline Trials
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Stemline Therapeutics, Inc.
Must be taking: Endocrine therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial involves a new drug, it's possible that some medications might need to be adjusted. Please consult with the trial coordinators for specific guidance.

Is the drug MEN2312 a promising treatment for breast cancer?

The information provided does not specifically mention MEN2312 or its effects on breast cancer, so we cannot determine if it is a promising treatment based on the given data.12345

What is the purpose of this trial?

This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adult participants with advanced breast cancer.

Eligibility Criteria

This trial is for adults with advanced breast cancer. Specific details about eligibility criteria are not provided, but typically participants would need to have a certain stage of cancer and meet health requirements set by the study.

Inclusion Criteria

I have been treated with hormone therapy for advanced cancer and it has stopped working.
My breast cancer is advanced and cannot be cured.
I've had up to 6 treatments before, including up to 2 chemotherapies for advanced cancer.

Exclusion Criteria

I have new or worsening brain metastases.
My cancer has not caused severe problems like uncontrolled fluid build-up or major lung or liver issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MEN2312 as monotherapy or in combination with elacestrant

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • MEN2312
Trial Overview The trial is testing MEN2312, a new drug that inhibits an enzyme called KAT6 which may play a role in cancer growth. It's being compared or used in conjunction with Elacestrant, another medication for breast cancer.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: MEN2312: MonotherapyExperimental Treatment1 Intervention
Participants will receive MEN2312.
Group II: MEN2312: Combination Therapy (Elacestrant)Experimental Treatment2 Interventions
Participants will receive MEN2312 in combination with elacestrant.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stemline Therapeutics, Inc.

Lead Sponsor

Trials
24
Recruited
6,500+

Stemline Therapeutics, Inc.

Lead Sponsor

Trials
24
Recruited
6,500+

Findings from Research

In a review of over 29,000 women from 61 randomized trials, chemotherapy significantly reduced disease mortality in Stage II breast cancer for both ER-positive and ER-negative premenopausal women, and possibly for ER-negative postmenopausal women.
Tamoxifen treatment for more than 2 years improved survival rates in postmenopausal Stage II ER-positive patients, while node-negative patients primarily benefited from improved disease-free survival rather than overall survival.
Breast cancer adjuvant therapy.Carbone, PP.[2019]
In a study of 281,829 female breast cancer patients, those aged 40 and younger exhibited significantly higher metastatic rates to bone, liver, and distant lymph nodes compared to older patients, indicating a more aggressive disease progression in younger women.
Young breast cancer patients, particularly those with HR+/HER2- tumors, had significantly shorter breast cancer-specific survival rates, suggesting that age is a critical negative prognostic factor and highlighting the need for tailored clinical management strategies.
Comparisons of Metastatic Patterns, Survival Outcomes and Tumor Immune Microenvironment Between Young and Non-Young Breast Cancer Patients.Sun, H., Huang, W., Ji, F., et al.[2022]
Women aged 25 years and younger with breast cancer are diagnosed at a more advanced stage and have a higher grade of cancer compared to older premenopausal women, indicating a more aggressive disease.
These young patients also experience significantly poorer overall survival and relapse-free survival rates, with hazard ratios indicating they are at a much higher risk of worse outcomes compared to their older counterparts.
Breast cancer in women aged 25 years and younger.Dimitrakakis, C., Tsigginou, A., Zagouri, F., et al.[2021]

References

Breast cancer adjuvant therapy. [2019]
Comparisons of Metastatic Patterns, Survival Outcomes and Tumor Immune Microenvironment Between Young and Non-Young Breast Cancer Patients. [2022]
Breast cancer in women aged 25 years and younger. [2021]
The place of chemotherapy in the treatment of early breast cancer. [2019]
Management of breast cancer in very young women. [2015]
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