Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 8, 2018
First Posted Date  ICMJE May 21, 2018
Last Update Posted Date August 13, 2019
Actual Study Start Date  ICMJE December 6, 2018
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03530696 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2018)
  • Compare response rates [ Time Frame: 4 years ]
    Compare response rates between both treatment arms
  • Compare overall survival [ Time Frame: 4 years ]
    Compare overall survival between both treatment arms
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer
Official Title  ICMJE 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
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
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HER2-positive Breast Cancer
  • Breast Cancer
  • Breast Cancer Stage
  • Recurrent Breast Cancer
  • Metastatic Breast Cancer
  • HER2 Positive Breast Carcinoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: T-DM1 with palbociclib
    T-DM1 is given IV every 21 days Palbociclib is administered days 5-18
    Interventions:
    • Drug: Palbociclib
    • Drug: T-DM1
  • Active Comparator: T-DM1
    T-DM1 is given IV every 21 days
    Intervention: Drug: T-DM1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 18, 2018)
132
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2022
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Niyuri Fleming 520-694-9079 nfleming@uacc.arizona.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03530696
Other Study ID Numbers  ICMJE 29747
T-DM1 ( Other Identifier: The University of Arizona Cancer Center )
Palbo T-DM1 ( Other Identifier: The University of Arizona Cancer Center )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Arizona
Study Sponsor  ICMJE University of Arizona
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Pavani Chalasani, MD The University of Arizona Cancer Center
PRS Account University of Arizona
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP