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

NCT02073916 | Completed Phase 1

• 2 other identifiers: Pro000095440813-0139
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer

Keywords

Breast Cancer; HER2 positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerable Dose

  Maximum tolerated dose (MTD) of Trastuzumab Emtansine in combination with Lapatinib plus Abraxane in metastatic Her2 over-expressed breast cancer.

  approximately 16 weeks

Secondary Outcomes (4)

• Dose Limiting Toxicities

  From date of randomization through study follow up (approximately 16 weeks)

• Measure toxicities associated with treatment combination

  From date of randomization through study follow up (approximately 16 weeks)

• Anti-tumor activity through imaging

  approximately 16 weeks from randomization

• Plasma pharmacokinetics and pharmacodynamic effect of treatment combination

  Day 1 and 1,2,4,and 24hours

Study Arms (1)

T-DM1 + Lapatinib + Abraxane

EXPERIMENTAL

T-DM1 with Laptinib followed by Abraxane

Drug: T-DM1; Drug: Lapatinib; Drug: Abraxane

Interventions

T-DM1 DRUG

antibody-drug conjugate of trastuzumab and emtansine

Also known as: Trastuzumab Emtansine, TE, Kadcyla

T-DM1 + Lapatinib + Abraxane

Lapatinib DRUG

Dual tyrosine kinase inhibitor (HER2 and EGFR)

Also known as: Tykerb

T-DM1 + Lapatinib + Abraxane

Abraxane DRUG

albumin-bound paclitaxel. Chemotherapy - microtubule inhibitor

Also known as: nab-paclitaxel

T-DM1 + Lapatinib + Abraxane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jenny C. Chang, MD: lead
• The Methodist Hospital Research Institute: collaborator

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ado-Trastuzumab Emtansine; Lapatinib; Albumin-Bound Paclitaxel; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Maytansine; Macrolides; Lactones; Organic Chemicals; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Trastuzumab; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Albumins

Study Officials

• Jenny C Chang, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator/Principal Investigator

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: February 27, 2014
• Study Start: October 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

US (1)