SHS_492450 KAPH CUAZ 18183

A randomized phase II study to evaluate efficacy of T-DM1 with or without Palbociclib in the treatment of patients with metastatic HER2 positive breast cancer

Inclusion Criteria:

Be informed of the investigational nature of the study and all pertinent aspects of the trial
Sign and provide written consent in accordance with institutional and federal guidelines.
ECOG Performance status of 0-2
Recurrent or metastatic HER2-positive breast cancer (HER2 positive is defined per ASCO-CAP guidelines)
Adequate cardiac reserve (EF≥50%)
Serum creatinine ≤ 1.5 x institutional upper limit of normal (IULN), bilirubin ≤ 2.0, and an SGOT/SGPT/alkaline phosphatase ≤ 2.0 x IULN
Adequate bone marrow function (ANC ≥1000, Platelets ≥100,000/ml, Hemoglobin ≥10gm/dL)
Be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures
Been treated with pertuzumab previously (neoadjuvant or metastatic setting). Patients who weren't able to tolerate pertuzumab due to side effects can be eligible for study upon discussion with the study PI
No more than 2 lines of therapy in the metastatic disease setting
Exclusion Criteria:

HER2 negative tumors
Prior treatment with T-DM1
Prior treatment with CDK 4/6 inhibitors
Known active CNS metastases or carcinomatous meningitis. Patients with stable CNS metastases including brain metastases who have completed a course of radiotherapy are eligible for the study provided they are clinically stable. However, oral corticosteroids for control of CNS symptoms are not allowed on study
Known documented or suspected hypersensitivity to the components of the study drug(s) or analogs.
Uncontrolled systemic illness, including but not limited to ongoing or active infection
Symptomatic congestive heart failure, unstable angina pectoris, stroke or myocardial infarction within 3 months
Be pregnant or breast feeding. Female subjects must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All female subjects with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment and must agree to use effective contraception during the period of therapy
Concurrent hormonal or other anti-neoplastic therapy is not allowed. Patients can receive supportive therapy like bone-directed therapy including bisphosphonates or denosumab
Phase II
Henry Kaplan, M.D.
University of Arizona
Mai Berenfeld
  • Swedish Medical Center