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Tucatinib for Breast Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, PABreast Cancer+21 MoreTucatinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial tests a combination of two drugs to see if they're better than one drug at preventing breast cancer from coming back in patients with high risk, HER2 positive breast cancer.

Eligible Conditions
  • HER2-positive Breast Cancer
  • Stage II Breast Cancer
  • Stage IA Breast Cancer
  • Stage IIA Breast Cancer
  • Stage III Breast Cancer
  • Stage 2 Breast Cancer
  • Stage IB Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage 1 Breast Cancer
  • Stage IIB Breast Cancer
  • Breast Cancer
  • Bilateral Breast Cancer
  • Multifocal Breast Cancer

Video Summary

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
Ribociclib
1
Tucatinib/Eribulin/Trastuzumab
1
Investigational Group

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Up to 10 years

Year 10
Brain metastases-free survival
Year 10
Breast cancer-free survival
Year 10
Modified invasive disease-free survival (iDFS)
Year 10
Distant recurrence-free survival
Year 10
Overall survival
Up to 10 years
Incidence of brain metastases
Unmodified invasive disease-free survival (iDFS)
Day 21
Quality of life

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Ribociclib
2
Tucatinib/Eribulin/Trastuzumab
2
Investigational Group

Trial Design

2 Treatment Groups

Arm I (trastuzumab emtansine, placebo)
1 of 2
Arm II (trastuzumab emtansine, tucatinib)
1 of 2

Active Control

Experimental Treatment

1031 Total Participants · 2 Treatment Groups

Primary Treatment: Tucatinib · Has Placebo Group · Phase 3

Arm II (trastuzumab emtansine, tucatinib)Experimental Group · 4 Interventions: Tucatinib, Trastuzumab Emtansine, Questionnaire Administration, Quality-of-Life Assessment · Intervention Types: Drug, Biological, Other, Other
Arm I (trastuzumab emtansine, placebo)ActiveComparator Group · 4 Interventions: Placebo Administration, Trastuzumab Emtansine, Questionnaire Administration, Quality-of-Life Assessment · Intervention Types: Drug, Biological, Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tucatinib
FDA approved
Trastuzumab emtansine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 10 years

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
506 Previous Clinical Trials
216,439 Total Patients Enrolled
75 Trials studying Breast Cancer
40,143 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,162 Previous Clinical Trials
41,166,356 Total Patients Enrolled
928 Trials studying Breast Cancer
1,536,821 Patients Enrolled for Breast Cancer
Seagen Inc.Industry Sponsor
188 Previous Clinical Trials
63,241 Total Patients Enrolled
6 Trials studying Breast Cancer
3,414 Patients Enrolled for Breast Cancer
Ciara C. O'Sullivan, MB, BCh, BAOStudy ChairMayo Clinic

Eligibility Criteria

Age 18+ · All Participants · 31 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your biopsy results show that you have HER2-positive cancer, which is determined by a score of 3+ on the IHC test or a positive result on the ISH test. The study does not require additional testing to confirm this status.
You have cancer in your breast and/or lymph nodes that is negative for hormone receptors but positive for HER2. If your cancer is positive for both hormone receptors and HER2, you must have cancer in your lymph nodes to qualify for the study. It is not required to have cancer remaining in the breast.
You have breast cancer with a low level of estrogen receptor (1-10%) and no cancer cells in your lymph nodes.
Doctors have determined the presence of hormone receptors using biopsy material. If you have positive estrogen or progesterone receptor status, you may be eligible to participate. If you have negative estrogen and progesterone receptor status, you may not be eligible.
You have been diagnosed with breast cancer that has spread to nearby lymph nodes or tissues and have undergone surgery to remove the tumor, but some cancer is still present. If you have been diagnosed with very early-stage breast cancer, you are not eligible to participate.
If you have breast cancer in both breasts and both tumors are HER2-positive, you may be eligible to participate as long as at least one of them meets the other study criteria. It's also okay if you have more than one tumor in the same breast, as long as the largest one is HER2-positive.

Who else is applying?

What state do they live in?
Illinois50.0%
Georgia50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Ingalls Memorial Hospital100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
Why did patients apply to this trial?
  • "I would like to help where I can, and I feel that these studies can make a difference"
How many prior treatments have patients received?
0100.0%
References

Frequently Asked Questions

Is there a high degree of risk when patients take Tucatinib?

"Tucatinib's safety is based on data from past Phase 3 trials, meaning that there is some evidence of the medication's efficacy and that it has undergone several rounds of testing for safety." - Anonymous Online Contributor

Unverified Answer

Are there other drugs similar to Tucatinib that have been studied before?

"Tucatinib was first researched in 2008 at A.O. Universitaria Pisana; Oncologia. Now, 284 studies have been completed with 60 more actively recruiting. A majority of these active studies are based in Mineola, New York." - Anonymous Online Contributor

Unverified Answer

Is this medical trial novel in any way?

"Tucatinib has a long history, with the very first clinical trials being conducted in 2008. Genentech, Inc. sponsored the initial study. Tucatinib received Phase 2 drug approval after the first study, which observed 720 patients. As of now, there are 60 active studies being conducted in 57 countries and 1549 cities." - Anonymous Online Contributor

Unverified Answer

How is Tucatinib most often employed in medical care?

"Tucatinib is most often associated with its ability to treat breast cancer, however, it can also be used as a last-line of defence against metastasis in patients that have already received anti-her2 treatments." - Anonymous Online Contributor

Unverified Answer

Are there any spots left in this research program for new participants?

"That is correct, the online information indicates that the study is currently looking for 1031 participants from 100 different locations. The original posting was on January 6th, 2021 with the most recent update being February 16th, 2022." - Anonymous Online Contributor

Unverified Answer

How many individuals are being trialed with this medication?

"The pharmaceutical company sponsoring this trial, Seagen Inc., needs 1031 eligible patients to participate. Seagen will be administering the trial from several hospitals, including NYU Winthrop Hospital in Mineola, New York and Armes Family Cancer Center in Findlay, Ohio." - Anonymous Online Contributor

Unverified Answer

In how many different places is this trial being run today?

"There are 4 primary locations for this trial: NYU Winthrop Hospital (Mineola, New York), Armes Family Cancer Center (Findlay, Ohio), UCHealth Highlands Ranch Hospital (Highlands Ranch, Colorado), and 100 other sites." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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