28 Participants Needed

Tucatinib for Metastatic Breast Cancer

Recruiting at 6 trial locations
AS
Nelson Moss, MD - MSK Neurosurgeon
Overseen ByNelson Moss, MD
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
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
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The purpose of this study to see how the brain absorbs, distributes, and gets rid of tucatinib in people who have HER2+ cancers (breast cancer, NSCLC, CRC, or GEC) that have spread to the brain, and to learn more about how cancer cells develop resistance to treatment. The researchers will do research tests to look for genetic differences between HER2+ breast cancer that has spread to the brain and progressed during treatment with tucatinib and cancers that are being treated with tucatinib for the first time.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use certain drugs that affect liver enzymes (CYP2C8 or CYP3A4) close to starting the trial. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug Tucatinib for metastatic breast cancer?

Tucatinib has been shown to be effective in treating advanced HER2-positive breast cancer, including cases with brain metastases. In a clinical trial, patients taking tucatinib with other drugs lived longer without their cancer getting worse compared to those who did not take tucatinib.12345

Is tucatinib safe for humans?

Tucatinib has been studied for safety in humans, and important safety concerns include diarrhea and liver issues. It was approved by the FDA for use in combination with other drugs for advanced breast cancer, indicating a favorable balance between benefits and risks.23456

How is the drug tucatinib unique for treating metastatic breast cancer?

Tucatinib is unique because it is an oral drug that selectively targets the HER2 protein, which is often overactive in certain breast cancers, and it has shown effectiveness in treating brain metastases, a common complication in HER2-positive breast cancer.12456

Research Team

AS

Andrew Seidman, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

Adults with HER2+ cancers that have spread to the brain, able to swallow pills, and expected to live more than 12 weeks. They should not have decision-making impairments or significant other illnesses as judged by a doctor. Women must test negative for pregnancy and agree to use contraception.

Inclusion Criteria

I have had multiple treatments for my condition.
I took lapatinib or neratinib over 6 months ago.
Life expectancy of >12 weeks
See 9 more

Exclusion Criteria

I am taking medication that interacts with certain enzymes and could cause serious side effects.
Significant medical co-morbidities as per investigator evaluation
I am not allergic to tucatinib or its ingredients.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Treatment

Participants receive tucatinib at a standard dose of 300 mg orally twice daily for 4 days prior to surgery

4 days

Surgery

Participants undergo clinically indicated brain surgery to resect HER2+ brain metastases

1 day

Follow-up

Participants are monitored for safety and effectiveness after surgery and treatment

3 days

Post-operative Monitoring

Participants may continue tucatinib post-operatively at the discretion of the treating oncologist with monitoring as per clinical routine

Treatment Details

Interventions

  • Tucatinib
Trial Overview The trial is testing how tucatinib behaves in the brain when treating HER2+ cancers that have metastasized there. It aims to understand drug distribution, elimination, and resistance development in patients undergoing surgery for these tumors.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Patients with documented radiological and/or clinical CNS progression with no prior tucatinibExperimental Treatment1 Intervention
Cohort B: Is to administer Tucatinib at standard dose of 300mg orally twice daily for 4 days prior to surgery (day -4 to 0).
Group II: Patients already on TucatinibExperimental Treatment1 Intervention
Cohort A: This is a non-interventional study patients who will enter while already on Tucatinib . Patients in cohort A who are already on Tucatinib at a dose reduction (i.e., for toxicity) will continue the same dose.
Group III: HER2+ esophagogastric, lung, or colon cancer brain metastases and HER2 mutant breast cancerExperimental Treatment1 Intervention
Cohort C: Is to administer Tucatinib at standard dose of 300mg orally twice daily for 4 days prior to surgery (day -4 to 0).

Tucatinib is already approved in United States, European Union, Switzerland for the following indications:

🇺🇸
Approved in United States as Tukysa for:
  • Metastatic HER2-positive breast cancer
  • RAS wild-type HER2-positive colorectal cancer
🇪🇺
Approved in European Union as Tukysa for:
  • HER2-positive locally advanced or metastatic breast cancer
🇨🇭
Approved in Switzerland as Tukysa for:
  • Metastatic HER2-positive breast cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Pfizer

Industry Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Seagen Inc.

Industry Sponsor

Trials
212
Recruited
73,800+
Founded
1997
Headquarters
Bothell, USA
Known For
Antibody-Drug Conjugates
Top Products
Adcetris (brentuximab vedotin), Tukysa (tucatinib), Padcev (enfortumab vedotin-ejfv), Tivdak (tisotumab vedotin-tftv)
Dr. Roger Dansey profile image

Dr. Roger Dansey

Seagen Inc.

Chief Medical Officer since 2018

MD from University of Witwatersrand

David R. Epstein profile image

David R. Epstein

Seagen Inc.

Chief Executive Officer since 2022

BSc in Pharmacy from Rutgers University, MBA from Columbia University

Findings from Research

In a phase I study involving 41 patients with HER2-positive brain metastases, the combination of tucatinib and trastuzumab was found to be tolerable, with a maximum tolerated dose of 300 mg twice daily or 750 mg once daily, and common side effects including elevated liver enzymes.
The treatment showed preliminary efficacy, with a clinical benefit rate of 35% in the twice-daily cohort and 53% in the once-daily cohort, indicating potential effectiveness in managing brain metastases in this patient population.
Phase I dose-escalation trial of tucatinib in combination with trastuzumab in patients with HER2-positive breast cancer brain metastases.Metzger Filho, O., Leone, JP., Li, T., et al.[2021]
In patients with HER2-positive metastatic breast cancer who had previously received multiple treatments, tucatinib combined with trastuzumab and capecitabine significantly improved progression-free survival at 1 year (33.1% vs. 12.3% for placebo) and overall survival at 2 years (44.9% vs. 26.6% for placebo).
Tucatinib was particularly effective for patients with brain metastases, showing a 1-year progression-free survival of 24.9% compared to 0% in the placebo group, although it was associated with higher rates of adverse events like diarrhea and elevated liver enzymes.
Tucatinib, Trastuzumab, and Capecitabine for HER2-Positive Metastatic Breast Cancer.Murthy, RK., Loi, S., Okines, A., et al.[2021]
Tucatinib, at a recommended phase 2 dose of 300 mg twice daily, demonstrated acceptable safety with manageable side effects, including diarrhea and nausea, in a study of 60 patients with HER2-positive breast cancer.
The combination of tucatinib with capecitabine or trastuzumab showed promising anti-tumor activity, with an objective response rate of 83% for tucatinib plus capecitabine, indicating its potential as an effective treatment option for patients who have progressed on other therapies.
Tucatinib with capecitabine and trastuzumab in advanced HER2-positive metastatic breast cancer with and without brain metastases: a non-randomised, open-label, phase 1b study.Murthy, R., Borges, VF., Conlin, A., et al.[2022]

References

Phase I dose-escalation trial of tucatinib in combination with trastuzumab in patients with HER2-positive breast cancer brain metastases. [2021]
Tucatinib, Trastuzumab, and Capecitabine for HER2-Positive Metastatic Breast Cancer. [2021]
Tucatinib with capecitabine and trastuzumab in advanced HER2-positive metastatic breast cancer with and without brain metastases: a non-randomised, open-label, phase 1b study. [2022]
FDA Approval Summary: Tucatinib for the Treatment of Patients with Advanced or Metastatic HER2-positive Breast Cancer. [2022]
The efficacy of tucatinib-based therapeutic approaches for HER2-positive breast cancer. [2022]
Tucatinib: First Approval. [2021]
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