MEN2312 for Breast Cancer

Recruiting at 59 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

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MEN2312 for individuals with advanced breast cancer. Researchers aim to determine the safety and effectiveness of MEN2312 when used alone or with another drug, elacestrant. This study targets those whose breast cancer has spread and who have not responded to other therapies. Participants should have specific genetic changes in their cancer and have experienced progression despite previous treatments. As a Phase 1 trial, this research focuses on understanding how MEN2312 works in people, offering participants the opportunity to be among the first to receive this new treatment.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that MEN2312 is undergoing its first human trials to assess safety. Limited information exists on how well people tolerate it. At this early stage, scientists focus on ensuring safety and determining the correct dose.

In this study, MEN2312 is combined with elacestrant, a drug previously used in breast cancer treatments. Studies indicate that elacestrant's safety profile is similar to other hormone therapies, suggesting it is generally well-tolerated.

As an early-stage study, detailed information on side effects or safety is not yet available. The goal is to confirm the treatments' safety and identify the optimal dose for future research. Participants will receive close monitoring to ensure their safety throughout the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike current standard treatments for breast cancer, which often involve chemotherapy, hormone therapy like tamoxifen, or targeted therapies like trastuzumab, MEN2312 is unique because it offers a novel approach. MEN2312 works as a monotherapy and also shows potential when combined with elacestrant, a selective estrogen receptor degrader (SERD). Researchers are excited because MEN2312 could target cancer cells more precisely, potentially reducing side effects and improving outcomes compared to traditional treatments. This innovative approach might provide new hope for patients, especially those who have not responded well to existing therapies.

What evidence suggests that MEN2312 could be an effective treatment for breast cancer?

Research shows that MEN2312 targets a protein called KAT6, which aids cancer cell growth. This suggests that MEN2312 might slow or stop the spread of advanced breast cancer. In this trial, participants will receive MEN2312 either alone or with elacestrant. Although MEN2312 is a new treatment, it offers hope for challenging cases. When combined with elacestrant, a drug effective in treating certain breast cancers, it could be even more potent. Elacestrant has improved survival for patients with advanced breast cancer. Together, these treatments might provide new options for patients who haven't responded to other therapies. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06638307

NCT06638307 | A First-in-Human Study of MEN2312 in ... This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adult participants with advanced breast cancer.

2. trialx.com trialx.com/5-breakthrough-breast-cancer-clinical-trials-currently-recruiting/

Clinical Trial Awareness: 5 Breakthrough Breast Cancer ... MEN2312 could become a new treatment option for people with advanced or hard-to-treat breast cancer, especially for those with certain genetic ...

3. conference-correspondent.com conference-correspondent.com/highlights/sabcs/sabcs-2024-breast-cancer/elacestrant-real-world-outcomes-exceed-expectations

Elacestrant Real-World Outcomes Exceed Expectations A recent study investigated the real-world effectiveness of elacestrant, a novel oral selective estrogen receptor degrader, in patients with hormone receptor ( ...

4. targetedonc.com targetedonc.com/view/real-world-data-reveal-longer-pfs-with-elacestrant-in-breast-cancer

Real-World Data Reveal Longer PFS With Elacestrant in ... Seth Wander, MD, PhD, discusses the extended survival with elacestrant in a real-world, which was longer than the randomized phase 3 trial data.

5. ajmc.com ajmc.com/view/elacestrant-shows-real-world-effectiveness-in-metastatic-breast-cancers

Elacestrant Shows Real-World Effectiveness in Metastatic ... Elacestrant was determined safe and effective following first line treatment for patients with ER-positive/HER2-negative advanced breast cancer.

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/547275

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

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11895172/

Post-marketing safety of elacestrant in breast cancer These data indicate that the safety profile of elacestrant in clinical trials is similar to that of other endocrine therapy drugs but with a ...

8. breastcancertrials.org breastcancertrials.org/bct_nation/mts/mtsResult.seam?zip=94107&searchTerm1=NCT06638307

MTS Trials - BreastCancerTrials.org Purpose: To study the safety, best dose, and effects (good and bad) of MEN2312, an experimental KAT6 inhibitor, alone or with elacestrant (Orserdu®) hormone ...