466 Participants Needed

Tucatinib + T-DM1 for Breast Cancer

Recruiting at 304 trial locations
ST
Overseen BySeagen Trial Information Support
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Seagen Inc.
Must be taking: T-DM1
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it does exclude those who have had certain treatments like tucatinib or similar drugs before. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug combination Tucatinib and T-DM1 for breast cancer?

Research shows that T-DM1, a combination of trastuzumab and a chemotherapy agent, is effective in treating HER2-positive breast cancer, especially in patients who have already tried other treatments. Tucatinib, when combined with T-DM1, is being developed as a new option for patients with advanced HER2-positive breast cancer, suggesting potential effectiveness.12345

Is the combination of Tucatinib and T-DM1 safe for treating breast cancer?

The combination of Tucatinib and T-DM1 has been studied for safety in patients with advanced HER2-positive breast cancer. Trastuzumab emtansine (T-DM1) has shown improved tolerability compared to some standard treatments, and Tucatinib is being developed as a targeted treatment. Overall, these treatments have been evaluated for safety in various studies, indicating they are generally safe for human use in the context of breast cancer.15678

What makes the drug Tucatinib + T-DM1 unique for breast cancer treatment?

Tucatinib + T-DM1 is unique because it combines an oral drug, Tucatinib, which specifically targets HER2 (a protein that promotes cancer cell growth), with T-DM1, an antibody-drug conjugate that delivers a chemotherapy agent directly to cancer cells. This combination offers a novel approach for patients with HER2-positive breast cancer who have already been treated with other therapies.127910

What is the purpose of this trial?

This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery.Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer.Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.

Research Team

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for adults with advanced or metastatic HER2+ breast cancer that has worsened after previous treatment or if they couldn't tolerate the last therapy. They should be relatively healthy (ECOG score of 0 or 1) and may have brain metastases if stable, treated, or not requiring immediate intervention. People can't join if they've had certain recent anti-HER2 treatments, large untreated brain lesions, need high-dose steroids for brain symptoms, have leptomeningeal disease, or uncontrolled seizures.

Inclusion Criteria

I am fully active or can carry out light work.
I have been treated with both a taxane and trastuzumab before.
My brain scan shows I may have brain metastases but don't need immediate treatment, or I've been treated for them and am stable or not needing immediate re-treatment.
See 3 more

Exclusion Criteria

I do not have large untreated brain lesions, uncontrolled seizures, or need high doses of steroids for brain symptoms.
I have not been treated with specific HER2 or EGFR targeting drugs recently.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tucatinib or placebo in combination with T-DM1 in 21-day cycles

Up to 43 months
Every 21 days for T-DM1 injections

Progression Assessment

Participants are assessed for disease progression every 6 weeks for the first 24 weeks, and every 9 weeks thereafter

Up to 43 months

Follow-up

Participants are monitored for overall survival and progression-free survival after treatment

Up to approximately 5 years

Treatment Details

Interventions

  • Placebo
  • T-DM1
  • Tucatinib
Trial Overview The study tests whether adding tucatinib to T-DM1 (a standard drug for this cancer type) improves outcomes in patients with HER2+ breast carcinoma compared to T-DM1 alone. Participants will either receive tucatinib pills twice daily plus T-DM1 injections every three weeks or placebo pills with T-DM1 injections in a blinded setup where neither patient nor doctor knows which treatment is given.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Tucatinib + T-DM1Experimental Treatment2 Interventions
Tucatinib + T-DM1
Group II: Placebo + T-DM1Active Control2 Interventions
Placebo + T-DM1

T-DM1 is already approved in European Union, United States, Canada, Japan, China for the following indications:

🇪🇺
Approved in European Union as Kadcyla for:
  • Breast cancer
🇺🇸
Approved in United States as Kadcyla for:
  • HER2-positive breast cancer
🇨🇦
Approved in Canada as Kadcyla for:
  • HER2-positive breast cancer
🇯🇵
Approved in Japan as Kadcyla for:
  • HER2-positive breast cancer
🇨🇳
Approved in China as Kadcyla for:
  • HER2-positive breast cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Seagen Inc.

Lead 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

Seagen, a wholly owned subsidiary of Pfizer

Lead Sponsor

Trials
20
Recruited
4,900+

Findings from Research

Tucatinib, when combined with T-DM1, was found to have a maximum tolerated dosage of 300 mg twice daily, showing acceptable toxicity levels in a phase 1b trial involving 57 patients with ERBB2/HER2-positive metastatic breast cancer.
The treatment demonstrated preliminary antitumor activity, with most adverse events being mild (grade 1 or 2), although some patients experienced more serious reactions like thrombocytopenia and hepatic transaminitis.
Tucatinib Combined With Ado-Trastuzumab Emtansine in Advanced ERBB2/HER2-Positive Metastatic Breast Cancer: A Phase 1b Clinical Trial.Borges, VF., Ferrario, C., Aucoin, N., et al.[2019]
In a phase 3 trial involving 1486 patients with HER2-positive early breast cancer, adjuvant treatment with trastuzumab emtansine (T-DM1) significantly reduced the risk of invasive disease or death by 50% compared to trastuzumab alone, with 12.2% of patients in the T-DM1 group experiencing these events versus 22.2% in the trastuzumab group.
The estimated 3-year invasive disease-free survival rate was 88.3% for the T-DM1 group compared to 77.0% for the trastuzumab group, indicating that T-DM1 is more effective in preventing recurrence after neoadjuvant therapy.
Trastuzumab Emtansine for Residual Invasive HER2-Positive Breast Cancer.von Minckwitz, G., Huang, CS., Mano, MS., et al.[2022]
In a study of 110 patients with HER2-positive metastatic breast cancer who had previously received multiple treatments, the antibody-drug conjugate trastuzumab emtansine (T-DM1) showed an overall response rate of 34.5% and a clinical benefit rate of 48.2%, indicating its effectiveness as a treatment option.
T-DM1 was well tolerated, with most side effects being mild (grades 1 to 2), and the most common severe side effects included thrombocytopenia and fatigue, suggesting a favorable safety profile for patients who have exhausted other HER2-targeted therapies.
A phase II study of trastuzumab emtansine in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer who were previously treated with trastuzumab, lapatinib, an anthracycline, a taxane, and capecitabine.Krop, IE., LoRusso, P., Miller, KD., et al.[2022]

References

Tucatinib Combined With Ado-Trastuzumab Emtansine in Advanced ERBB2/HER2-Positive Metastatic Breast Cancer: A Phase 1b Clinical Trial. [2019]
Trastuzumab Emtansine for Residual Invasive HER2-Positive Breast Cancer. [2022]
A phase II study of trastuzumab emtansine in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer who were previously treated with trastuzumab, lapatinib, an anthracycline, a taxane, and capecitabine. [2022]
Patient-reported outcomes from KATHERINE: A phase 3 study of adjuvant trastuzumab emtansine versus trastuzumab in patients with residual invasive disease after neoadjuvant therapy for human epidermal growth factor receptor 2-positive breast cancer. [2021]
Trastuzumab emtansine in human epidermal growth factor receptor 2-positive metastatic breast cancer: an integrated safety analysis. [2019]
Safety Evaluation of Trastuzumab Emtansine in Japanese Patients with HER2-Positive Advanced Breast Cancer. [2022]
Safety Profile and Costs of Related Adverse Events of Trastuzumab Emtansine for the Treatment of HER2-Positive Locally Advanced or Metastatic Breast Cancer Compared to Capecitabine Plus Lapatinib from the Perspective of the Canadian Health-Care System. [2019]
Safety of trastuzumab emtansine (T-DM1) in patients with HER2-positive advanced breast cancer: Primary results from the KAMILLA study cohort 1. [2020]
Trastuzumab emtansine (T-DM1) as adjuvant treatment of HER2-positive early breast cancer: safety and efficacy. [2021]
Treatment of HER2 positive advanced breast cancer with T-DM1: A review of the literature. [2022]
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