Back to resultsT-DM1 With Abraxane and Lapatinib for Metastatic HER2 Positive Breast Cancer (STELA)
Primary Purpose
Metastatic Breast Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
T-DM1
Lapatinib
Abraxane
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring Breast Cancer, HER2 positive Breast Cancer
Eligibility 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.
Sites / Locations
- Houston Methodist Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
T-DM1 + Lapatinib + Abraxane
Arm Description
T-DM1 with Laptinib followed by Abraxane
Outcomes
Primary Outcome Measures
Maximum Tolerable Dose
Maximum tolerated dose (MTD) of Trastuzumab Emtansine in combination with Lapatinib plus Abraxane in metastatic Her2 over-expressed breast cancer.
Secondary Outcome Measures
Dose Limiting Toxicities
Describe the dose-limiting toxicity (DLT) associated with Trastuzumab Emtansine in combination with Lapatinib plus Abraxane as assessed by CTCAE v4.0.
Measure toxicities associated with treatment combination
Describe and measure other toxicities associated with Trastuzumab Emtansine in combination with Lapatinib plus Abraxane as assessed by CTCAE v4.0.
Anti-tumor activity through imaging
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
Plasma pharmacokinetics and pharmacodynamic effect of treatment combination
Determine the plasma pharmacokinetics of Trastuzumab Emtansine in combination with Lapatinib plus Abraxane.
Full Information
NCT ID
NCT02073916
First Posted
February 18, 2014
Last Updated
April 12, 2019
Sponsor
Jenny C. Chang, MD
Collaborators
The Methodist Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02073916
Brief Title
T-DM1 With Abraxane and Lapatinib for Metastatic HER2 Positive Breast Cancer
Acronym
STELA
Official Title
Phase Ib Trial of Trastuzumab Emtansine In Combination With Lapatinib Plus Abraxane In Metastatic Her 2 Neu Over-Expressed Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jenny C. Chang, MD
Collaborators
The Methodist Hospital Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
Breast Cancer, HER2 positive Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
T-DM1 + Lapatinib + Abraxane
Arm Type
Experimental
Arm Description
T-DM1 with Laptinib followed by Abraxane
Intervention Type
Drug
Intervention Name(s)
T-DM1
Other Intervention Name(s)
Trastuzumab Emtansine, TE, Kadcyla
Intervention Description
antibody-drug conjugate of trastuzumab and emtansine
Intervention Type
Drug
Intervention Name(s)
Lapatinib
Other Intervention Name(s)
Tykerb
Intervention Description
Dual tyrosine kinase inhibitor (HER2 and EGFR)
Intervention Type
Drug
Intervention Name(s)
Abraxane
Other Intervention Name(s)
nab-paclitaxel
Intervention Description
albumin-bound paclitaxel. Chemotherapy - microtubule inhibitor
Primary Outcome Measure Information:
Title
Maximum Tolerable Dose
Description
Maximum tolerated dose (MTD) of Trastuzumab Emtansine in combination with Lapatinib plus Abraxane in metastatic Her2 over-expressed breast cancer.
Time Frame
approximately 16 weeks
Secondary Outcome Measure Information:
Title
Dose Limiting Toxicities
Description
Describe the dose-limiting toxicity (DLT) associated with Trastuzumab Emtansine in combination with Lapatinib plus Abraxane as assessed by CTCAE v4.0.
Time Frame
From date of randomization through study follow up (approximately 16 weeks)
Title
Measure toxicities associated with treatment combination
Description
Describe and measure other toxicities associated with Trastuzumab Emtansine in combination with Lapatinib plus Abraxane as assessed by CTCAE v4.0.
Time Frame
From date of randomization through study follow up (approximately 16 weeks)
Title
Anti-tumor activity through imaging
Description
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
Time Frame
approximately 16 weeks from randomization
Title
Plasma pharmacokinetics and pharmacodynamic effect of treatment combination
Description
Determine the plasma pharmacokinetics of Trastuzumab Emtansine in combination with Lapatinib plus Abraxane.
Time Frame
Day 1 and 1,2,4,and 24hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenny C Chang, MD
Organizational Affiliation
The Methodist Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
T-DM1 With Abraxane and Lapatinib for Metastatic HER2 Positive Breast Cancer
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