66 Participants Needed

Zelenectide Pevedotin for Breast Cancer

Recruiting at 5 trial locations
BL
Overseen ByBicycleTx Limited
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop any systemic anticancer therapy at least 28 days before starting the study treatment. Additionally, you cannot take medications that strongly affect certain liver enzymes (CYP3A) or P-glycoprotein while on the study.

What data supports the effectiveness of the drug Zelenectide Pevedotin for breast cancer?

Research shows that combining paclitaxel, a component similar to Zelenectide Pevedotin, with other drugs like bevacizumab improves outcomes in metastatic breast cancer, suggesting potential effectiveness for Zelenectide Pevedotin.12345

What is the purpose of this trial?

This is a global, multicenter, open-label study that aims to assess the efficacy and safety of zelenectide pevedotin in participants with NECTIN4-amplified recurrent, unresectable, or metastatic breast cancer who have received prior therapy (see inclusion criteria below). The study will comprise of 2 cohorts. Cohort A will include participants with hormone receptor positive/ human epidermal growth factor receptor 2 negative \[HR+/HER2-\] breast cancer, whereas Cohort B will include participants with triple-negative breast cancer (TNBC).

Eligibility Criteria

This trial is for people with advanced breast cancer that has come back or spread and can't be removed by surgery. Participants must have a life expectancy of at least 12 weeks, be relatively active (able to care for themselves), and have measurable disease. They need confirmed NECTIN4 gene amplification and should have received some prior therapy but not too much: up to 3 treatments if their cancer grows despite hormone therapy, or between 1-3 treatments if they have triple-negative breast cancer.

Inclusion Criteria

I can provide tissue samples for gene testing from my advanced breast cancer.
My cancer can be measured by standard health scans.
My doctor expects me to live for at least 12 more weeks.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive zelenectide pevedotin for NECTIN4-amplified advanced breast cancer

Up to approximately 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 4 years

Treatment Details

Interventions

  • Zelenectide Pevedotin
Trial Overview The study is testing Zelenectide pevedotin on two groups of patients with advanced breast cancer: those whose tumors grow despite hormone therapy (HR+/HER2-) and those with triple-negative breast cancer. It's an open-label study, meaning everyone knows what treatment they're getting, aiming to see how effective and safe this new drug is.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Cohort B (TNBC)Experimental Treatment1 Intervention
Group II: Cohort A (HR+/HER2-negative breast cancer)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

BicycleTx Limited

Lead Sponsor

Trials
5
Recruited
1,800+

Findings from Research

Adjuvant chemotherapy significantly improves survival in node-positive breast cancer patients, with a 23.5% reduction in recurrence and a 15% reduction in mortality, particularly benefiting hormone receptor-negative patients more than receptor-positive ones.
Tamoxifen, while effective, may reduce the efficacy of chemotherapy in hormone receptor-positive patients by inducing the anti-apoptotic gene Bcl-2, which can lead to decreased drug sensitivity, suggesting that chemotherapy should precede tamoxifen treatment for optimal outcomes.
A pitfall in the survival benefit of adjuvant chemotherapy for node- and hormone receptor-positive patients with breast cancer: the paradoxical role of Bcl-2 oncoprotein (review).Kim, R., Osaki, A., Toge, T.[2019]
In a phase II trial involving 76 patients with HER2/neu-negative metastatic breast cancer, the combination of docetaxel and bevacizumab showed a promising objective response rate of 51%, with a median overall survival of 26.3 months.
The treatment was generally well tolerated, with manageable side effects, although common grade 3/4 adverse events included neutropenia (33%) and leukopenia/lymphopenia (25%).
A phase II trial of docetaxel with bevacizumab as first-line therapy for HER2-negative metastatic breast cancer (TORI B01).Hurvitz, SA., Allen, HJ., Moroose, RL., et al.[2020]
In a retrospective analysis of 40 women with metastatic breast cancer treated with albumin-bound paclitaxel and bevacizumab, there was an overall response rate of 48.5%, with 16 out of 33 women showing objective responses (3 complete and 13 partial).
The treatment was well tolerated, with common side effects including fatigue, neuropathy, pain, and hypertension, suggesting that this combination could be a safer option for patients compared to traditional therapies.
Bevacizumab and albumin-bound paclitaxel treatment in metastatic breast cancer.Link, JS., Waisman, JR., Nguyen, B., et al.[2015]

References

A pitfall in the survival benefit of adjuvant chemotherapy for node- and hormone receptor-positive patients with breast cancer: the paradoxical role of Bcl-2 oncoprotein (review). [2019]
A phase II trial of docetaxel with bevacizumab as first-line therapy for HER2-negative metastatic breast cancer (TORI B01). [2020]
Bevacizumab and albumin-bound paclitaxel treatment in metastatic breast cancer. [2015]
2'-Behenoyl-paclitaxel conjugate containing lipid nanoparticles for the treatment of metastatic breast cancer. [2021]
Independent review of E2100: a phase III trial of bevacizumab plus paclitaxel versus paclitaxel in women with metastatic breast cancer. [2022]
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