MEN2312 for Breast Cancer

Recruiting at 38 trial locations

Overseen By Stemline Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Stemline Therapeutics, Inc.

Must be taking: Endocrine therapy

Disqualifiers: Brain metastasis, Severe organ spread, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

124 Participants Needed

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. ^{1 2 3 4 5}

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

Group I: MEN2312: Monotherapy Experimental Treatment 1 Intervention

Participants will receive MEN2312.

Group II: MEN2312: Combination Therapy (Elacestrant) Experimental Treatment 2 Interventions

Participants will receive MEN2312 in combination with elacestrant.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer in women aged 25 years and younger. Dimitrakakis, C., Tsigginou, A., Zagouri, F., et al.[2021]

Combination chemotherapy, particularly with cyclophosphamide, methotrexate, and 5-fluorouracil (CMF), is more effective than single-agent chemotherapy for premenopausal women with node-positive breast cancer, showing significant benefits in reducing recurrence and mortality rates.

While tamoxifen is effective for ER-positive breast cancer, there is a need for more large-scale trials to compare the efficacy of endocrine therapy versus chemotherapy, as combination chemoendocrine therapy may offer additional benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The place of chemotherapy in the treatment of early breast cancer. Buzdar, A.[2019]

Young women with breast cancer often face more aggressive subtypes and advanced stages of the disease, leading to lower survival rates compared to older women, despite improvements in treatment outcomes.

Breast-conserving therapy is a viable option for young women, as survival rates are equivalent to those undergoing mastectomy, but many are opting for bilateral mastectomy without hereditary risk, highlighting the need for personalized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of breast cancer in very young women. Rosenberg, SM., Partridge, AH.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

Breast cancer adjuvant therapy. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Comparisons of Metastatic Patterns, Survival Outcomes and Tumor Immune Microenvironment Between Young and Non-Young Breast Cancer Patients. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Breast cancer in women aged 25 years and younger. [2021]

4. England pubmed.ncbi.nlm.nih.gov

The place of chemotherapy in the treatment of early breast cancer. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Management of breast cancer in very young women. [2015]