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T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer (T-DM1)

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ClinicalTrials.gov Identifier: NCT03530696
Recruitment Status : Recruiting
First Posted : May 21, 2018
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Arizona

Brief Summary:
This is a randomized phase II study to evaluate if the combination of T-DM1 with palbociclib improves progression-free survival compared to single agent T-DM1in patients with metastatic HER2 positive breast cancer

Condition or disease Intervention/treatment Phase
HER2-positive Breast Cancer Breast Cancer Breast Cancer Stage Recurrent Breast Cancer Metastatic Breast Cancer HER2 Positive Breast Carcinoma Drug: Palbociclib Drug: T-DM1 Phase 2

Detailed Description:

This is a multi-center, randomized, phase II study of T-DM1 with or without palbociclib in the treatment of patients with metastatic HER2-positive breast cancer. Patients will be randomized 1:1 to T-DM1 with or without palbociclib.

Hypotheses: Combination of T-DM1 with palbociclib improves progression free survival compared to single agent T-DM1

Primary objective: Compare progression free survival of the combination arm (T-DM1 with palbociclib) to single agent T-DM1

Secondary objectives i) Compare response rates between both treatment arms ii) Compare overall survival between both treatment arms

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : December 6, 2018
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: T-DM1 with palbociclib
T-DM1 is given IV every 21 days Palbociclib is administered days 5-18
Drug: Palbociclib
Compare progression free survival of the combination arm (T-DM1 with palbociclib) to single agent T-DM1
Other Name: Ibrance

Drug: T-DM1
Compare progression free survival of the combination arm (T-DM1 with palbociclib) to single agent T-DM1
Other Name: Kadcyla

Active Comparator: T-DM1
T-DM1 is given IV every 21 days
Drug: T-DM1
Compare progression free survival of the combination arm (T-DM1 with palbociclib) to single agent T-DM1
Other Name: Kadcyla




Primary Outcome Measures :
  1. Compare progression-free survival [ Time Frame: 4 years ]
    Compare progression-free survival of the combination arm (T-DM1 with palbociclib) to single agent T-DM1


Secondary Outcome Measures :
  1. Compare response rates [ Time Frame: 4 years ]
    Compare response rates between both treatment arms

  2. Compare overall survival [ Time Frame: 4 years ]
    Compare overall survival between both treatment arms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03530696


Contacts
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Contact: Niyuri Fleming 520-694-9079 nfleming@uacc.arizona.edu

Locations
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United States, Arizona
University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85724
Contact: Amy Selegue, BA, BSN, RN    520-626-0301    aselegue@email.arizona.edu   
Principal Investigator: Pavani Chalasani, MD         
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Kyrie Dailey    720-848-9456    KYRIE.DAILEY@UCDENVER.EDU   
Principal Investigator: Peter Kabos, MD         
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06519
Contact: Erin Hofstatter, MD       erin.hofstatter@yale.edu   
Principal Investigator: Erin Hofstatter, MD         
United States, New York
Roswell Park Comprehensive Cancer center Recruiting
Buffalo, New York, United States, 14263
Contact    800-767-9355    ASKRoswell@Roswellpark.org   
Principal Investigator: Mateusz Opyrchal, MD         
United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Rita Murphy       Rita.Murphy@jefferson.edu   
Principal Investigator: Maysa Abu-Khalaf, MD         
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Contact: Hank Kaplan       Hank.Kaplan@swedish.org   
Principal Investigator: Hank Kaplan, MD         
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Jennifer Specht, MD    206-606-6329    jspecht@uw.edu   
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53706
Contact: UW Cancer Connect    608-262-5223      
Contact    800-622-8922      
Principal Investigator: Kari Wisinski, MD         
Sponsors and Collaborators
University of Arizona
Pfizer
Investigators
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Principal Investigator: Pavani Chalasani, MD The University of Arizona Cancer Center

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Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT03530696     History of Changes
Other Study ID Numbers: 29747
T-DM1 ( Other Identifier: The University of Arizona Cancer Center )
Palbo T-DM1 ( Other Identifier: The University of Arizona Cancer Center )
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by University of Arizona:
Breast Cancer
HER2-positive
T-DM1
HER2-positive Breast Cancer
Recurrent Breast Cancer
Metastatic Breast Cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Palbociclib
Ado-trastuzumab emtansine
Trastuzumab
Maytansine
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic