T-DM1 With Abraxane and Lapatinib for Metastatic HER2 Positive Breast Cancer (STELA)
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|ClinicalTrials.gov Identifier: NCT02073916|
Recruitment Status : Completed
First Posted : February 27, 2014
Last Update Posted : April 16, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: T-DM1 Drug: Lapatinib Drug: Abraxane||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: T-DM1 + Lapatinib + Abraxane
T-DM1 with Laptinib followed by Abraxane
antibody-drug conjugate of trastuzumab and emtansine
Dual tyrosine kinase inhibitor (HER2 and EGFR)
Other Name: Tykerb
albumin-bound paclitaxel. Chemotherapy - microtubule inhibitor
Other Name: nab-paclitaxel
- 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.
- 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.
- 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.
- 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
- 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|
- 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)
- 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.
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
|United States, Texas|
|Houston Methodist Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jenny C Chang, MD||The Methodist Hospital Research Institute|
|Responsible Party:||Jenny C. Chang, MD, Sponsor-Investigator/Principal Investigator, The Methodist Hospital Research Institute|
|Other Study ID Numbers:||
0813-0139 ( Other Identifier: HMRI IRB )
|First Posted:||February 27, 2014 Key Record Dates|
|Last Update Posted:||April 16, 2019|
|Last Verified:||April 2019|
HER2 positive Breast Cancer
Neoplasms by Site
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Protein Kinase Inhibitors
Physiological Effects of Drugs