T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer

Completed · Phase 2

Conditions studied: HER2-positive Breast Cancer, Breast Cancer, Breast Cancer Stage, Recurrent Breast Cancer, Metastatic Breast Cancer, HER2 Positive Breast Carcinoma

In brief

This is a single arm, phase II study to evaluate if the combination of T-DM1 with palbociclib improves progression-free survival in patients with metastatic HER2 positive breast cancer. All patients will be treated with T-DM1 with palbociclib.

Key facts

Study ID

NCT03530696

Run by

University of Arizona

People needed

55

Starts

2018-12-06

Expected to finish

2022-12-22

Last updated by the study team

2024-08-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Arizona Cancer Center — Tucson, Arizona, United States
• Cedar-Sinai — Beverly Hills, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Mosaic Life Care — Saint Joseph, Missouri, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• Roswell Park Comprehensive Cancer center — Buffalo, New York, United States
• UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Oregon Health and Sciences University — Portland, Oregon, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• JPS Health Network — Fort Worth, Texas, United States
• Swedish Cancer Institute — Seattle, Washington, United States
• University of Washington — Seattle, Washington, United States
• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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