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Antimetabolites

Zunsemetinib + Capecitabine for Breast Cancer

Phase 1 & 2

Waitlist Available

Led By Cynthia X Ma, M.D., Ph.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must have received prior endocrine therapy with CDK4/6 inhibitor

Hormone receptor-positive, HER2-negative metastatic breast cancer

Must not have

History of active malignancy

Progressive bone metastasis per the most recent tumor imaging studies by RECIST 1.1 or clinical progression (such as worsening bone pain, elevation of tumor marker) per treating physician for Phase II

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of two drugs, zunsemetinib and capecitabine, in patients with a specific type of advanced breast cancer to see how safe and effective it is

Who is the study for?

This trial is for individuals with HR+/HER2- metastatic breast cancer that has spread to the bones. Participants should not have received certain prior treatments and must meet specific health conditions.

What is being tested?

The study tests zunsemetinib combined with capecitabine's effectiveness in treating breast cancer. It's a phase Ib/II trial, which means it's looking at safety and how well the drugs work together.

What are the potential side effects?

Possible side effects may include typical reactions to chemotherapy like nausea, fatigue, diarrhea, low blood cell counts leading to increased infection risk, and potential bone-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been treated with hormone therapy and CDK4/6 inhibitors.

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My breast cancer is hormone receptor-positive and HER2-negative.

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I am fully active or can carry out light work.

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I have had only one chemotherapy for my advanced cancer.

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I am 18 years old or older.

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My blood counts and organ functions are within normal ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of cancer.

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My cancer has spread to my bones and is getting worse.

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I have had a condition where lymphocytes grow abnormally.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Phase Ib: Zunsemetinib + CapecitabineExperimental Treatment2 Interventions

Patients will receive zunsemetinib by mouth (PO) twice per day (BID) at an assigned dose along with capecitabine (1000 mg/m\^2 PO BID on Days 1-14 an every 21-day cycle). For patients enrolled in phase Ib, capecitabine is dosed on days 2-15 during cycles 1-2. Dose escalation of zunsemetinib will utilize a 3+3 design. A maximum of 3 dose levels of zunsemetinib will be tested, and the two highest dose levels which did not lead to more than 1 of 6 patients with DLT in cycle 1 will be chosen as the RP2D-L1 and RP2D-L2 for Phase II. If only one dose level of zunsemetinib was found tolerable, then only one RP2D will be chosen for Phase II.

Group II: Phase II Arm 3: Zunsemetinib (RP2D-L2) + CapecitabineExperimental Treatment2 Interventions

Patients will receive zunsemetinib by mouth (PO) twice per day (BID) at an assigned dose. In general, capecitabine will be taken twice daily at a dose of 1000 mg/m\^2 on Days 1 through 14 of every 21-day cycle. The first 4 patients enrolling to phase II will take capecitabine on a different schedule for PK purposes in Cycles 1 and 2 ONLY. Patients will take capecitabine at a dose of 1000mg/m\^2 on Days 2 through 15 of Cycles 1 and 2, and then on Days 1 through 14 starting with Cycle 3. If only one dose level of zunsemetinib plus capecitabine was found tolerable in phase Ib testing, the phase II trial will proceed with 2:1 two-arm randomization with Arm 2 of capecitabine plus zunsemetinib and Arm 1 of capecitabine plus standard of care anti-resorptive agent.

Group III: Phase II Arm 2: Zunsemetinib (RP2D-L1) + CapecitabineExperimental Treatment2 Interventions

Group IV: Phase II Arm 1: Standard of care anti-resorptive + CapecitabineActive Control3 Interventions

Standard of care anti-resorptives will consist of bisphosphonate (zoledronic acid) is to be administered every 4-12 weeks, or denosumab is to be administered every 4-6 weeks, as per physician choice and institutional practice. In general, capecitabine will be taken twice daily at a dose of 1000 mg/m\^2 on Days 1 through 14 of every 21-day cycle. The first 4 patients enrolling to phase II will take capecitabine on a different schedule for PK purposes in Cycles 1 and 2 ONLY. Patients will take capecitabine at a dose of 1000mg/m\^2 on Days 2 through 15 of Cycles 1 and 2, and then on Days 1 through 14 starting with Cycle 3.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Capecitabine

2013

Completed Phase 3

~3960

0 / 9Eligibility criteria met