Ibrutinib + Trastuzumab for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of two drugs, ibrutinib (a type of cancer treatment) and trastuzumab, to determine the best dosage and monitor side effects in treating a specific type of breast cancer that has spread and worsened after previous treatment. The goal is to assess how these drugs work together against HER2-amplified metastatic breast cancer, where cancer cells have an excess of a growth-promoting protein. Women with this type of breast cancer, whose condition has progressed within six months of their last treatment, might be suitable for this study.
As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking cancer research.
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 medications like strong CYP3A inhibitors or warfarin. It's best to discuss your current medications with the study team to see if they are allowed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using ibrutinib and trastuzumab together has been generally safe in past studies. Patients experienced some side effects, but these were usually not serious. Ibrutinib is taken as a pill, while trastuzumab is administered through an IV. Together, they target HER2-positive breast cancer.
Earlier research tested these treatments on cells and animals, showing positive effects on cancer cells. However, in human trials, although the combination was safe, it did not always achieve the desired effectiveness.
The current trial examines how different doses of ibrutinib are tolerated when used with trastuzumab. As an early-stage trial, the focus is on identifying the highest dose that can be tolerated without serious side effects. Researchers are still determining the best and safest way to use these drugs together in people.
As with any clinical trial, potential risks should be considered, but the treatment appears safe for most patients so far.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Ibrutinib and Trastuzumab for breast cancer because it targets the disease in a novel way. Unlike traditional treatments, which often focus on chemotherapy or hormone therapy, Ibrutinib is a Bruton's tyrosine kinase (BTK) inhibitor that can interfere with cancer cell growth and survival pathways. This mechanism could potentially enhance the effectiveness of Trastuzumab, a monoclonal antibody that targets HER2-positive breast cancer cells. By combining these two approaches, there is hope for improved outcomes in patients who might not respond well to current standard treatments.
What evidence suggests that this trial's treatments could be effective for metastatic breast cancer?
Studies have shown that trastuzumab blocks signals that prompt cancer cells to grow, making it effective for HER2-positive breast cancer. Research suggests that ibrutinib has shown promise in early studies, particularly in breast cancer models, by halting processes that aid cancer growth. This trial examines the combination of ibrutinib and trastuzumab, as they might work better together and potentially overcome resistance seen in some breast cancer treatments. Although more research is needed, early signs indicate this combination could benefit patients whose cancer has worsened after other treatments.12467
Who Is on the Research Team?
Joyce O'Shaughnessy, MD
Principal Investigator
US Oncology Research/McKesson Specialty Health
Are You a Good Fit for This Trial?
This trial is for women aged 18 or older with HER2-amplified metastatic breast cancer that worsened after T-DM1 therapy. Participants can have had up to four prior chemotherapy treatments, must not be pregnant, and agree to use two effective birth control methods. They should have good heart function (LVEF ≥ 50%), adequate blood counts, liver and kidney function, and an ECOG performance status of 0-2.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase I Treatment
Dose-escalation study to evaluate the maximum tolerated dose and dose-limiting toxicities of ibrutinib in combination with trastuzumab
Phase II Treatment
Treatment with the maximum tolerated dose of ibrutinib plus trastuzumab to assess clinical benefit rate
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ibrutinib
- Trastuzumab
Trial Overview
The study tests different doses of Ibrutinib (560 mg, 840 mg, or 420 mg daily) combined with Trastuzumab administered intravenously. It aims to find the highest dose patients can take without serious side effects in those who've previously been treated with ado-trastuzumab emtansine for metastatic breast cancer.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
If no patients in 560 mg arm have DLTs, this arm will be opened in Phase I to see how this higher dose is tolerated.
In Phase I, starting dose of Ibrutinib will be 560 mg orally per day. 3 patients will be enrolled first. If none of these have DLTs, 3 new patients will be enrolled at the next higher Ibrutinib dose level (840 mg orally per day). If 1 of these 3 patients have a DLT, expand this arm to 6 patients. If 2 or more of these 6 patients have a DLT, enroll 3 patients in lower dose lever (420 mg).
If 2 or more patients in 560 mg arm have DLTs, this arm will be opened in Phase I to see how this lower dose is tolerated.
Maximum tolerated dose from Phase I will be used here in Phase II.
Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:
- Chronic lymphocytic leukemia
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
- Marginal zone lymphoma
- Graft-versus-host disease
- Chronic lymphocytic leukemia/small lymphocytic lymphoma
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
- Marginal zone lymphoma
- Graft-versus-host disease
- Chronic lymphocytic leukemia
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
- Marginal zone lymphoma
- Chronic lymphocytic leukemia
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
US Oncology Research
Lead Sponsor
AbbVie
Industry Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois
Pharmacyclics LLC.
Industry Sponsor
Dr. Maky Zanganeh
Pharmacyclics LLC.
Chief Executive Officer
Degree from Louis Pasteur University in Strasbourg, France; MBA from Schiller International University in France
Dr. Ellie Im
Pharmacyclics LLC.
Chief Medical Officer
MD from an unspecified institution
Citations
Trial of Ibrutinib Plus Trastuzumab in HER2-amplified ...
This is a Phase I/II, open-label dose-escalation study designed to evaluate the maximum tolerated dose (MTD) and dose-limiting side effects of ibrutinib (560 ...
2.
ohcare.com
ohcare.com/ohc-researchers-evaluating-new-combination-drugs-her2-positive-breast-cancer/New Combination of Drugs for HER2-positive Breast Cancer
“Trastuzumab works by blocking the ability of the cancer cells to receive chemical signals that tell the cells to grow,” explained Dr. Lang. “ ...
3.
clinicaltrials.gov
clinicaltrials.gov/study/NCT03379428?term=AREA%5BConditionSearch%5D(%22Breast%20Neoplasms%22)%20AND%20AREA%5BBasicSearch%5D(gene%20therapy)&rank=3Trial of Ibrutinib Plus Trastuzumab in HER2-amplified Metastatic ...
The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.
Ibrutinib in Gynecological Malignancies and Breast Cancer
Our findings showed that preclinical studies generally confirm ibrutinib's efficacy in cell lines and animal models of ovarian, breast, and endometrial cancer.
A Systematic Review
Outcomes were discounted by 3.5%. RESULTS: Treatment with ibrutinib resulted in better health outcomes, incrementally increasing overall LYs by 0.92, 0.86, and ...
6.
researchgate.net
researchgate.net/publication/380311931_Abstract_PO1-04-03_Phase_III_Trial_of_Ibrutinib_Plus_Trastuzumab_in_HER2-Positive_Metastatic_Breast_CancerPhase I/II Trial of Ibrutinib Plus Trastuzumab in HER2- ...
Conclusion: Ibrutinib plus trastuzumab had a manageable safety profile; however, the CBR did not reach the protocol-specified goal of 28%, and these results do ...
Ibrutinib + Trastuzumab for Breast Cancer
This trial tests a combination of ibrutinib (a pill) and trastuzumab (an IV drug) in patients with HER2-amplified Metastatic Breast Cancer that has worsened ...
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