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T-DM1 With Abraxane and Lapatinib for Metastatic HER2 Positive Breast Cancer (STELA)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02073916
Recruitment Status : Completed
First Posted : February 27, 2014
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
The Methodist Hospital System
Information provided by (Responsible Party):
Jenny C. Chang, MD, The Methodist Hospital System

Brief Summary:
This open-label, single-center Phase Ib study will assess the safety and tolerability of combining trastuzumab emtansine (T-DM1) with Lapatinib and Abraxane in patients with metastatic HER2-positive breast cancer.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: T-DM1 Drug: Lapatinib Drug: Abraxane Phase 1

Detailed Description:
This open-label, single-center Phase Ib study will assess the safety and tolerability of combining trastuzumab emtansine (T-DM1) with Lapatinib and Abraxane in patients with metastatic HER2-positive breast cancer. Patients will receive Abraxane on Day 1 of each 1-week cycle and T-DM1 on Day 1 of each 3-week cycle. Patients with take Lapatinib orally daily. Patients will receive the study treatment for 12 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ib Trial of Trastuzumab Emtansine In Combination With Lapatinib Plus Abraxane In Metastatic Her 2 Neu Over-Expressed Breast Cancer Patients
Actual Study Start Date : October 2013
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: T-DM1 + Lapatinib + Abraxane
T-DM1 with Laptinib followed by Abraxane
Drug: T-DM1
antibody-drug conjugate of trastuzumab and emtansine
Other Names:
  • Trastuzumab Emtansine
  • TE
  • Kadcyla

Drug: Lapatinib
Dual tyrosine kinase inhibitor (HER2 and EGFR)
Other Name: Tykerb

Drug: Abraxane
albumin-bound paclitaxel. Chemotherapy - microtubule inhibitor
Other Name: nab-paclitaxel




Primary Outcome Measures :
  1. Maximum Tolerable Dose [ Time Frame: approximately 16 weeks ]
    Maximum tolerated dose (MTD) of Trastuzumab Emtansine in combination with Lapatinib plus Abraxane in metastatic Her2 over-expressed breast cancer.


Secondary Outcome Measures :
  1. Dose Limiting Toxicities [ Time Frame: From date of randomization through study follow up (approximately 16 weeks) ]
    Describe the dose-limiting toxicity (DLT) associated with Trastuzumab Emtansine in combination with Lapatinib plus Abraxane as assessed by CTCAE v4.0.

  2. Measure toxicities associated with treatment combination [ Time Frame: From date of randomization through study follow up (approximately 16 weeks) ]
    Describe and measure other toxicities associated with Trastuzumab Emtansine in combination with Lapatinib plus Abraxane as assessed by CTCAE v4.0.

  3. Anti-tumor activity through imaging [ Time Frame: approximately 16 weeks from randomization ]
    Document anti-tumor activity of Trastuzumab Emtansine in combination with Lapatinib plus Abraxane in metastatic Her2 over-expressed breast cancer as assessed by RECIST 1:1 criteria

  4. Plasma pharmacokinetics and pharmacodynamic effect of treatment combination [ Time Frame: Day 1 and 1,2,4,and 24hours ]
    Determine the plasma pharmacokinetics of Trastuzumab Emtansine in combination with Lapatinib plus Abraxane.



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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:

  • Documented metastatic Her2 over-expressed breast cancer.
  • Age ≥ 18 years Patients must have received at least two prior therapies for their malignant disease.
  • Patients must have < Grade 2 pre-existing peripheral neuropathy (per CTCAE)
  • Adequate organ function (cardiac ejection fraction of ≥ 45%),
  • CBC not less than .75 of institutional lower limit.
  • Patients must have adequate liver function: AST and ALT < 2.5 X upper limit of normal, alkaline phosphatase < 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis Bilirubin < 1.5 mg/dL
  • Patients must have adequate renal function: creatinine <1.5 mg/dL is recommended; however, institutional norms are acceptable.
  • Negative serum or urine β-hCG pregnancy test at screening for patients of childbearing potential
  • Fertile patients must use effective contraception (barrier method - condoms, diaphragm - also in conjunction with spermicidal jelly, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not allowed). Contraception method must be used during treatment and for three months after completing treatment Signed informed consent form (ICF)

Exclusion Criteria:

  • Any medical or psychiatric condition that would prevent informed consent or limit survival to less than 4 weeks.
  • Absolute QT interval of >460 msec in the presence of potassium >4.0mEq/L and Magnesium >1.8mg/dl.
  • Patient with HIV and post- transplant associated lymphoproliferative disorders.
  • Patient with concurrent use of complementary or alternative medicines that would confound the interpretation of toxicities and antitumor activity of Trastuzumab Emtansine, Lapatinib or Abraxane.
  • Pregnant or lactating women.
  • Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trastuzumab Emtansine, lapatinib, abraxane, or their components.
  • Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.
  • Subjects with ulcerative colitis are also excluded.

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): NCT02073916


Locations
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United States, Texas
Houston Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Jenny C. Chang, MD
The Methodist Hospital System
Investigators
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Principal Investigator: Jenny C Chang, MD The Methodist Hospital System

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Responsible Party: Jenny C. Chang, MD, Sponsor-Investigator/Principal Investigator, The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT02073916    
Other Study ID Numbers: Pro00009544
0813-0139 ( Other Identifier: HMRI IRB )
First Posted: February 27, 2014    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Keywords provided by Jenny C. Chang, MD, The Methodist Hospital System:
Breast Cancer
HER2 positive Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Maytansine
Ado-trastuzumab emtansine
Albumin-Bound Paclitaxel
Trastuzumab
Lapatinib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Protein Kinase Inhibitors
Enzyme Inhibitors