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Protocol No. UW18089

Principal Investigator Wisinski, Kari

Phase II

Age Group Adult

Scope National

Sponsor Type Industry; Institutional

Title 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

Objective The purpose of this study is to see if combination treatment of T-DM1 with palbociclib is better than T-DM1 alone for metastatic HER2 positive breast cancer. Palbociclib is considered investigational in this combination because this combination has not been approved to be used for treatment in the United States by the Food and Drug Administration (FDA), at this time. However, Palbociclib is currently approved in combination with an aromatase inhibitor or fulvestrant (hormonal therapy) for treatment of hormone receptor positive, HER2 negative metastatic breast cancer

Treatment 2 different groups:
  • T-DM1 given intravenously on day 1 of every cycle, in combination with the study drug Palbociclib taken orally days 5 to 18 of each cycle(cycle=3 weeks)
  • T-DM1 given intravenously on day 1 of every cycle.

  • Description Phase II study with T-DM1 with or without Palbociclib in Metastatic HER2 positive Breast Cancer

    Key Eligibility
  • 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
  • Age greater than or equal to 18 years
  • ECOG Performance status of 0-2
  • Recurrent or metastatic HER2-positive breast cancer (HER2 positive is defined per ASCO-CAP guidelines)
  • Measurable disease by RECIST 1.1
  • Adequate cardiac reserve (Left ventricular ejection fraction greater than or equal to 50%
  • Adequate liver, renal and bone marrow function as described by the protocol
  • 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 were not 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
  • Can not be pregnant or breast feeding and must agree to use adequate birth control as defined by the protocol
  • 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
  • Concurrent hormonal or other anti-neoplastic therapy is not allowed. Patients can receive supportive therapy like bone-directed therapy including bisphosphonates or denosumab. Other supportive care medications can be used if clinically indicated (like growth factor support)

  • Applicable Disease Sites Breast

    Status Open

    Participating Institutions UW Hospital and Clinics; UWCCC 1 South Park