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T-DM1 and Palbociclib in Treating Patients with Metastatic HER2 Positive Breast Cancer

Trial Status: Active

This phase II trial studies how well T-DM1 and palbociclib work in treating patients with HER2 positive breast cancer that has spread to other parts of the body (metastatic). T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called DM1. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers DM1 to kill them. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and palbociclib may help treat patients with HER2 positive metastatic 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.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Recurrent or metastatic HER2-positive breast cancer (HER2 positivity is defined per American Society of Clinical Oncology-College of American Pathologists [ASCO-CAP] guidelines).
  • Must have one of the following by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * Measurable disease or * Evaluable disease
  • Adequate cardiac reserve (left ventricular ejection fraction >= 50%).
  • Serum creatinine =< 1.5 x institutional upper limit of normal (IULN).
  • Bilirubin =< 2.0.
  • Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT)/alkaline phosphatase =< 2.0 x IULN.
  • Absolute neutrophil count (ANC) >= 1000.
  • Platelets >= 100,000/ml.
  • Hemoglobin >= 10 gm/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.
  • No more than 2 lines of therapy in the metastatic disease setting.
  • 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. Women of childbearing potential and men should use effective methods of contraception during the entire duration on study and for 7 months after completion.

Exclusion Criteria

  • HER2 negative tumors.
  • Prior treatment with T-DM1 in the metastatic setting. If treated with prior T-DM1 in the neoadjuvant or adjuvant setting, a treatment free interval of at least 12 months.
  • Prior treatment with CDK 4/6 inhibitors.
  • Known active symptomatic central nervous system (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.
  • Concurrent endocrine therapy 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). If a patient is on GnRH (gonadotrophin releasing hormone) agonist for ovarian suppression, they can continue it. If a patient is already on a Gonadotrophin releasing hormone agonists, it can be continued during this study.


Banner University Medical Center - Tucson
Status: ACTIVE
Contact: Pavani Chalasani
Phone: 520-626-7725
University of Arizona Cancer Center-North Campus
Status: ACTIVE
Contact: Pavani Chalasani
Phone: 520-626-7725


Los Angeles
Cedars Sinai Medical Center
Status: ACTIVE
Contact: Parisa Mirzadehgan


University of Colorado Hospital
Status: ACTIVE
Contact: Peter Kabos
Phone: 303-724-4690


New Haven
Yale University
Status: ACTIVE
Contact: Erin Wysong Hofstatter


Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE
Contact: Vered Stearns


Saint Joseph
Heartland Regional Medical Center
Status: ACTIVE
Contact: Christina Hughes
Phone: 816-271-7654

New Mexico

University of New Mexico Cancer Center
Status: ACTIVE
Contact: Ursa A. Brown-Glaberman
Las Cruces
Memorial Medical Center - Las Cruces
Status: ACTIVE
Contact: Kim W. Hoffman
Phone: 575-556-6545

New York

Roswell Park Cancer Institute
Status: ACTIVE
Contact: Mateusz Opyrchal

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: ACTIVE
Contact: Shannon Tole
Phone: 984-974-8658


Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Status: ACTIVE
Contact: Alycia Marie Gatta
Phone: 866-223-8100


OHSU Knight Cancer Institute
Status: ACTIVE
Contact: Zahi Mitri
Phone: 503-494-8534


Thomas Jefferson University Hospital
Contact: Maysa M. Abu-Khalaf


Fort Worth
Tarrant County Hospital District / JPS Health Network
Status: ACTIVE
Contact: Anna Diaz
Phone: 817-702-2349


Swedish Medical Center-First Hill
Status: ACTIVE
Contact: Hank Kaplan
University of Washington Medical Center - Montlake
Status: ACTIVE
Contact: Jennifer Marie Specht
Phone: 206-606-6329


University of Wisconsin Hospital and Clinics
Status: ACTIVE
Contact: Kari Braun Wisinski


I. Estimate progression free survival of trastuzumab emtansine (T-DM1) + palbociclib.


I. Estimate response rates of T-DM1 + palbociclib treatment regimen.

II. Estimate overall survival of T-DM1+ palbociclib treatment regimen.


I. Investigate predictive biomarkers of response in blood and archived tumor tissue.

II. Investigate mechanisms of resistance for palbociclib in blood and tumor tissue.


Patients receive trastuzumab emtansine intravenously (IV) over 30-90 minutes on day 1 and palbociclib orally (PO) on days 5-18. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity.

After conclusion of study treatment, patients are followed up at 30 days and then every 6 months.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Banner University Medical Center - Tucson

Principal Investigator
Pavani Chalasani

  • Primary ID 29747
  • Secondary IDs NCI-2018-01988
  • ID NCT03530696