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A Phase II, Single-arm, Open-label Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Progressed While Receiving HER2-Directed Therapy


Phase 2
N/A
N/A
Not Enrolling
Both
Metastatic Breast Cancer

Thank you

Trial Information

A Phase II, Single-arm, Open-label Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Progressed While Receiving HER2-Directed Therapy


Inclusion Criteria:



- Signed informed consent form.

- Human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer
(MBC); tissue (slides or blocks) available for HER2 confirmation.

- History of progression on HER2-directed therapy for the treatment of HER2-positive
breast cancer.

- At least 1, and no more than 3, chemotherapy regimens for MBC.

- Granulocyte count ≥ 1500/μL, platelet count ≥ 100,000/μL, and hemoglobin ≥ 9 g/dL.

- Serum bilirubin ≤ 1.5 mg/dL, aspartate aminotransferase (AST), alanine
aminotransferase (ALT), and alkaline phosphatase ≤ 2.5x the upper limit of normal
(ULN).

- Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 60 mL/min.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

Exclusion Criteria:

- Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biological
therapy for the treatment of breast cancer within 2 weeks of the first study
treatment.

- Prior cumulative doxorubicin dose > 360 mg/m^2 or the equivalent.

- History of significant cardiac disease, unstable angina, congestive heart failure
(CHF), myocardial infarction, or ventricular arrythmia requiring medication.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Description:

Objective response was defined as a complete response (CR) or partial response (PR) determined on 2 consecutive occasions ≥ 4 weeks apart, using Response Evaluation Criteria in Solid Tumors (RECIST). CR: The disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR: Disappearance of all target lesions and persistence of ≥ 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.

Outcome Time Frame:

Randomization until the analysis data cutoff-dates of 31 Jan 2009 (6 months after the last patient was enrolled in the study) and 25 Jun 2009 (approximately 12 months after the last patient was enrolled in the study, up to 23 months)

Safety Issue:

No

Principal Investigator

Scott Holden, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

TDM4258g

NCT ID:

NCT00509769

Start Date:

July 2007

Completion Date:

June 2009

Related Keywords:

  • Metastatic Breast Cancer
  • Trastuzumab emtansine
  • MBC
  • Breast cancer
  • HER2-positive breast cancer
  • HER2
  • Breast Neoplasms

Name

Location

Texas Oncology, P.A. Dallas, Texas  75246
Rocky Mountain Cancer Center Denver, Colorado  80218
Mayo Clinic Jacksonville, Florida  32224
Missouri Cancer Associates Columbia, Missouri  65201
Washington Cancer Institute Washington, District of Columbia  20010
Northwest Cancer Specialists Vancouver, Washington  98664
Kentuckiana Cancer Institute Louisville, Kentucky  40202
Northern Utah Associates Ogden, Utah  84403
Bay Area Oncology Tampa, Florida  33607
Northwest Medical Specialties Tacoma, Washington  98405
New York Oncology Hematology Albany, New York  12208
Texas Oncology Cancer Center Austin, Texas  78731
Sammons Cancer Center Dallas, Texas  
Gulfcoast Oncology Associates St. Petersburg, Florida  33705
US Oncology Houston, Texas  77060
Texas Oncology PA Dallas, Texas  75231
El Paso Cancer Treatment Ctr El Paso, Texas  79915
St. Barnabas Health Care Sys Livingston, New Jersey  07039
Hem/Onc Assoc - Treasure Coast Port St Lucie, Florida  34952
St. Louis Cancer & Breast Inst Saint Louis, Missouri  63141
Eastchester Center/Cancer Care Bronx, New York  10469
USO Dallas, Texas  75230-2510
USO - Tyler Cancer Ctr Tyler, Texas  75702
Waco Cancer Care & Research Ce Waco, Texas  76712
Fairfax N Virginia Hem/Onc PC Fairfax, Virginia  22031
Kansas City Cancer Center, LLC Kansas City, Missouri  64131
Little Rock Hem Onc Assoc Little Rock, Arkansas  72205
Lynn Cancer Institute - West Boca Raton, Florida  33428
Florida Cancer Care Davie, Florida  33328
Northwest Georgia Onc Ctrs PC Marietta, Georgia  30060
John McClean, M.D. - Private P Galesburg, Illinois  61401
Cedar Valley Med Specialists Waterloo, Iowa  50702
Minnesota Oncology Hematology, Minneapolis, Minnesota  55404
Carolinas Hem-Oncology Assoc Charlotte, North Carolina  28203
Raleigh Hemotology & Oncology Raleigh, North Carolina  27607
Midwestern Regional Med Center Eugene, Oregon  97401-8122
Cancer Specialists of South Te Corpus Christi, Texas  78412
US Oncology Research, Inc. Dallas, Texas  75204