A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer
18 Years and older, Male and Female
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.
This study is designed to evaluate the efficacy and safety of tucatinib in combination with
T-DM1 in subjects with unresectable locally-advanced or metastatic HER2+ breast cancer who
have had prior treatment with a taxane and trastuzumab in any setting. Prior pertuzumab
treatment is permitted, but not required. Subjects will be randomized in a 1:1 manner to
receive 21-day cycles of either tucatinib or placebo in combination with T-DM1.
While on study treatment, subjects will be assessed for progression every 6 weeks for the
first 24 weeks, and every 9 weeks thereafter, irrespective of dose holds or interruptions.
Study treatment will continue until unacceptable toxicity, disease progression, withdrawal of
consent, or study closure. After completion of study treatment and after occurrence of
disease progression, subjects in both arms of the study will continue to be followed for
survival until study closure or withdrawal of consent.
- Histologically confirmed HER2+ breast carcinoma as determined by a sponsor-designated central laboratory
- History of prior treatment with a taxane and trastuzumab in any setting, separately or in combination
- Have progression of unresectable locally advanced/metastatic breast cancer after last systemic therapy, or be intolerant of last systemic therapy
- Measurable or non-measurable disease assessable by RECIST v1.1
- ECOG performance status score of 0 or 1
- CNS Inclusion - Based on screening contrast brain magnetic resonance imaging (MRI), subjects must have at least one of the following: (a) No evidence of brain metastases (b) Untreated brain metastases not needing immediate local therapy (c) Previously treated brain metastases
- Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy, provided that there is no clinical indication for immediate re-treatment with local therapy
- Subjects treated with CNS local therapy for newly identified lesions or previously treated and progressing lesions may be eligible to enroll if all of the following criteria are met: (i) Time since SRS is at least 7 days prior to first dose of study treatment, time since WBRT is at least 21 days prior to first dose, or time since surgical resection is at least 28 days. (ii) Other sites of evaluable disease are present
- Relevant records of any CNS treatment must be available to allow for classification of target and non-target lesions -
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials