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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03530696
Other study ID # 29747
Secondary ID T-DM1Palbo T-DM1
Status Completed
Phase Phase 2
First received
Last updated
Start date December 6, 2018
Est. completion date December 22, 2022

Study information

Verified date August 2023
Source University of Arizona
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

This is a multi-center, single arm, phase II study of T-DM1 with palbociclib in the treatment of patients with metastatic HER2-positive breast cancer. Hypotheses: Combination of T-DM1 with palbociclib improves progression free survival Primary objective: Progression free survival of the combination of T-DM1 with palbociclib Secondary objectives i) Response rates ii) Overall survival Correlative objectives i) Investigate predictive biomarkers of response in blood and archived tumor tissue ii) Investigate mechanisms of resistance for palbociclib in blood and tumor tissue


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date December 22, 2022
Est. primary completion date December 22, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Be informed of the investigational nature of the study and all pertinent aspects of the trial 2. Sign and provide written consent in accordance with institutional and federal guidelines. 3. ECOG Performance status of 0-2 4. Recurrent or metastatic HER2-positive breast cancer (HER2 positive is defined per ASCO-CAP guidelines) 5. Adequate cardiac reserve (EF=50%) 6. Serum creatinine = 1.5 x institutional upper limit of normal (IULN), bilirubin = 2.0, and an SGOT/SGPT/alkaline phosphatase = 2.0 x IULN 7. Adequate bone marrow function (ANC =1000, Platelets =100,000/ml, Hemoglobin =10gm/dL) 8. Be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures 9. 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 10. No more than 2 lines of therapy in the metastatic disease setting Exclusion Criteria: 1. HER2 negative tumors 2. Prior treatment with T-DM1 3. Prior treatment with CDK 4/6 inhibitors 4. 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 5. Known documented or suspected hypersensitivity to the components of the study drug(s) or analogs. 6. Uncontrolled systemic illness, including but not limited to ongoing or active infection 7. Symptomatic congestive heart failure, unstable angina pectoris, stroke or myocardial infarction within 3 months 8. 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 9. Concurrent hormonal or other anti-neoplastic therapy is not allowed. Patients can receive supportive therapy like bone-directed therapy including bisphosphonates or denosumab

Study Design


Intervention

Drug:
Palbociclib
Palbociclib is to be taken orally on days 5-18 (14 days) of each cycle (each cycle length is 21 days). The starting dose will be 125mg.
T-DM1
The recommended dose of T-DM1 is 3.6 mg/kg and is given as an intravenous infusion on Day 1 of every cycle (every 21 days).

Locations

Country Name City State
United States University of New Mexico Albuquerque New Mexico
United States University of Colorado Denver Aurora Colorado
United States Johns Hopkins Hospital Baltimore Maryland
United States Cedar-Sinai Beverly Hills California
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 JPS Health Network Fort Worth Texas
United States University of Wisconsin Madison Wisconsin
United States Yale Cancer Center New Haven Connecticut
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States Oregon Health and Sciences University Portland Oregon
United States Mosaic Life Care Saint Joseph Missouri
United States Swedish Cancer Institute Seattle Washington
United States University of Washington Seattle Washington
United States University of Arizona Cancer Center Tucson Arizona

Sponsors (2)

Lead Sponsor Collaborator
University of Arizona Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Estimate progression-free survival Estimate progression free survival of T-DM1 + palbociclib 4 years
Secondary Estimate response rates Estimate response rates of T-DM1+Palbociclib treatment regimen 4 years
Secondary Estimate overall survival survival Estimate overall survival of T-DM1+Palbociclib treatment regimen 4 years
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