30 Participants Needed

Triple Drug Combo for Advanced Breast Cancer

Recruiting at 5 trial locations
ML
RS
JH
FA
Overseen ByFelicitas Ambrose
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

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

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently on warfarin or other coumarin derivatives, or if you have used strong CYP3A4 or CYP2C8 inhibitors or inducers recently. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the triple drug combo for advanced breast cancer?

The combination of HER2-targeted drugs like trastuzumab (Herceptin) and tucatinib (Tukysa) has shown to significantly improve outcomes for patients with HER2-positive advanced breast cancer. Additionally, eribulin has been proven to extend overall survival in patients with advanced breast cancer who have undergone multiple prior treatments.12345

Is the triple drug combo for advanced breast cancer safe?

The combination of eribulin and trastuzumab has been shown to be generally safe and well-tolerated in patients with advanced HER2-positive breast cancer. Common side effects include neutropenia (low white blood cell count), which is manageable, and no severe heart issues were observed. However, regular monitoring of heart function is recommended.678910

What makes the triple drug combo of Eribulin, Trastuzumab, and Tucatinib unique for advanced breast cancer?

This triple drug combo is unique because it combines Eribulin, which is promising in combination with Trastuzumab for HER2-positive breast cancer, with Tucatinib, a newer drug that specifically targets HER2, potentially offering a more comprehensive treatment approach for advanced cases.1112131415

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and efficacy of the three-drug combination of tucatinib, trastuzumab, and eribulin in patients with de novo and recurrent unresectable metastatic HER-2/neu positive breast cancer as assessed by ORR, PFS and OS after prior treatment with a taxane, trastuzumab, and T-DM1.

Research Team

HK

Hank Kaplan, MD

Principal Investigator

henry.kaplan@swedish.org

Eligibility Criteria

This trial is for adults with HER2+ breast cancer that's advanced and can't be surgically removed. Participants must have had prior treatments including trastuzumab and a taxane, but not necessarily tucatinib. They should be in relatively good health otherwise, able to follow the study plan, and women of childbearing age must test negative for pregnancy.

Inclusion Criteria

My liver is functioning well.
I agree to use effective birth control during the study.
Have a life expectancy of at least 6 months, in the opinion of the site investigator
See 13 more

Exclusion Criteria

I have chronic Hepatitis B, C, or another long-term liver disease.
All side effects from my previous cancer treatments are mild.
You have been diagnosed with HIV.
See 14 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tucatinib, trastuzumab, and eribulin in 21-day cycles

2 years
Every 21 days (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Eribulin
  • Trastuzumab
  • Tucatinib
Trial Overview The trial tests how safe and effective the combination of tucatinib, trastuzumab, and eribulin is in treating patients who've already received certain other breast cancer treatments. The effectiveness will be measured by tumor response rate, progression-free survival (PFS), and overall survival (OS).
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Tucatinib/Eribulin/TrastuzumabExperimental Treatment3 Interventions
* The initial dose of trastuzumab will be given as a loading dose of 8 mg/kg intravenously (IV), unless trastuzumab was administered within the prior 4 weeks, then the initial dose of trastuzumab will be administered at a dose of 6 mg/kg. Each trastuzumab dose is given once every 21 days, except in specific circumstances where it may be given weekly to compensate for modifications in treatment schedule * Tucatinib 300 mg orally twice daily (PO BID) every day (Days 1-21) of each 21-day cycle using a modified schedule of events. Subcutaneous trastuzumab is given only once every three weeks as there is no allowance for weekly dosing. * Eribulin will be given at a dose of 1.4 mg/M2 intravenously over a 2-5 minute period on days 1 and 8 of each 21-day cycle.

Eribulin is already approved in European Union, United States, Japan, Canada for the following indications:

🇪🇺
Approved in European Union as Halaven for:
  • Locally advanced or metastatic breast cancer
🇺🇸
Approved in United States as Halaven for:
  • Metastatic breast cancer
  • Liposarcoma
🇯🇵
Approved in Japan as Halaven for:
  • Breast cancer
  • Soft tissue sarcoma
🇨🇦
Approved in Canada as Halaven for:
  • Metastatic breast cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Criterium, Inc.

Lead Sponsor

Trials
18
Recruited
730+

Findings from Research

HER2 overexpression is a significant factor in 20% of breast cancers, leading to poor patient prognosis, but targeted therapies like trastuzumab, lapatinib, and pertuzumab have been shown to significantly improve outcomes for HER2-positive patients.
The FDA has recently approved the combination of trastuzumab, pertuzumab, and docetaxel as a first-line treatment for metastatic breast cancer, along with trastuzumab emtansine (T-DM1), highlighting the ongoing advancements in HER2-targeted therapies and the need to address challenges like drug resistance.
HER2-directed therapy for metastatic breast cancer.Jelovac, D., Emens, LA.[2014]
HER2-positive breast cancer, which affects about 20% of patients, has seen improved outcomes with new targeted therapies like trastuzumab and pertuzumab, especially in first-line treatment.
Emerging therapies such as tucatinib and fam-trastuzumab deruxtecan are expanding treatment options for advanced HER2-positive breast cancer, with ongoing research into biomarkers to enhance patient selection and address specific needs like brain metastasis.
Current and Future Management of HER2-Positive Metastatic Breast Cancer.Martínez-Sáez, O., Prat, A.[2022]
HER2-positive breast cancer, which historically had a poor prognosis, can now be effectively treated with a variety of anti-HER2 therapies, significantly improving patient survival rates.
Newly developed treatments, including trastuzumab deruxtecan and trastuzumab emtansine, along with ongoing clinical trials, are expanding options for patients with advanced HER2-positive breast cancer, raising important questions about the best treatment sequences and combinations.
Anti-HER2 Drugs for the Treatment of Advanced HER2 Positive Breast Cancer.Stanowicka-Grada, M., Senkus, E.[2023]

References

HER2-directed therapy for metastatic breast cancer. [2014]
Current and Future Management of HER2-Positive Metastatic Breast Cancer. [2022]
Anti-HER2 Drugs for the Treatment of Advanced HER2 Positive Breast Cancer. [2023]
Phase 2 Study of Dose-Dense Doxorubicin and Cyclophosphamide Followed by Eribulin Mesylate With or Without Prophylactic Growth Factor for Adjuvant Treatment of Early-Stage Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer. [2023]
Eribulin mesylate for the treatment of patients with refractory metastatic breast cancer: use of a "physician's choice" control arm in a randomized approval trial. [2016]
Long-term combination chemotherapy using eribulin and trastuzumab for three patients with human epidermal growth factor receptor 2-positive metastatic breast cancer. [2020]
Pertuzumab, trastuzumab and eribulin mesylate therapy for previously treated advanced HER2-positive breast cancer: a feasibility study with analysis of biomarkers. [2019]
Phase 1 combination study of eribulin mesylate with trastuzumab for advanced or recurrent human epidermal growth factor receptor 2 positive breast cancer. [2021]
A phase II study of efficacy, toxicity, and the potential impact of genomic alterations on response to eribulin mesylate in combination with trastuzumab and pertuzumab in women with human epidermal growth factor receptor 2 (HER2)+ metastatic breast cancer. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Phase 2, multicenter, single-arm study of eribulin mesylate with trastuzumab as first-line therapy for locally recurrent or metastatic HER2-positive breast cancer. [2022]
Long-term efficacy and safety of a third-line treatment with eribulin plus trastuzumab in a young breast cancer patient. [2016]
Taxane versus vinorelbine in combination with trastuzumab and pertuzumab for first-line treatment of metastatic HER2-positive breast cancer: a retrospective two-center study. [2021]
First report of eribulin in combination with pertuzumab and trastuzumab for advanced HER2-positive breast cancer. [2018]
14.United Statespubmed.ncbi.nlm.nih.gov
Maximizing clinical benefit with trastuzumab. [2019]
A phase IIa dose-finding and safety study of first-line pertuzumab in combination with trastuzumab, capecitabine and cisplatin in patients with HER2-positive advanced gastric cancer. [2021]
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