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A Phase II, Open-Label Study to Evaluate Corrected QT Interval Effects of Trastuzumab-MCC-DM1 (T-DM1) in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer and to Evaluate the Safety and Tolerability of Combined T-DM1 and Pertuzumab in Patients With Early Disease Progression While Receiving T-DM1 Alone


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

Thank you

Trial Information

A Phase II, Open-Label Study to Evaluate Corrected QT Interval Effects of Trastuzumab-MCC-DM1 (T-DM1) in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer and to Evaluate the Safety and Tolerability of Combined T-DM1 and Pertuzumab in Patients With Early Disease Progression While Receiving T-DM1 Alone


Inclusion Criteria:



- Histologically documented, locally advanced, or metastatic breast cancer; measurable
and/or non-measureable but evaluable disease is permitted

- HER2-positive disease

- History of prior trastuzumab therapy

- Life expectancy ≥ 90 days as assessed by the investigator

- Negative urine pregnancy test ≤ 72 hours prior to Cycle 1 Day 1 for all women of
childbearing potential

- For patients of childbearing potential, agreement to use one highly effective form of
contraception or two effective forms of contraception for the duration of the study
treatment(s) and for 4 months after the last dose of T-DM1 or 6 months after the last
dose of pertuzumab, if applicable

Exclusion Criteria:

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

- Prior T-DM1 or pertuzumab therapy

- History of intolerance (such as Grade 3-4 infusion reaction) and/or adverse events
related to trastuzumab

- Grade ≥ 2 (based on National Cancer Institute Common Terminology Criteria for Adverse
Events [NCI CTCAE] v3) peripheral neuropathy at the time of or within 3 weeks prior
to the first study treatment

- Brain metastases that are untreated or progressive or have required any type of
therapy, including radiation, surgery, and/or steroids, to control symptoms from
brain metastases within 60 days prior to the first study treatment

- History of cardiac disease, unstable angina, symptomatic congestive heart failure
(CHF) (Class ≥ II per the New York Heart Associate [NYHA] guidelines), myocardial
infarction, or ventricular arrhythmia ≤ 6 months prior to Cycle 1, Day 1

- Implantable pacemaker or automatic implantable cardioverter defibrillator

- Congenital long QT syndrome or family history of long QT syndrome

- Current uncontrolled hypertension

- Current treatment with medications that alter cardiac conduction (e.g., digitalis,
beta-blockers, or calcium channel blockers) or medications that are generally
accepted to have a risk of causing torsades de pointes (TdP)

- Current known active infection with human immunodeficiency virus (HIV), hepatitis B
virus, or hepatitis C virus

- Major surgical procedure or significant traumatic injury within 28 days prior to
first study treatment, or anticipation of the need for major surgery during the
course of study treatment

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change From Baseline in Mean Duration of the QTc Interval

Outcome Description:

The QT interval is a measure of time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The corrected QT interval was calculated using Fridericia's correction (QTcF) from electrocardiogram (ECG) data. Each participant had triplicate QTcF intervals measured at each timepoint and the average was calculated for each patient at each timepoint. For each timepoint, a participant's corresponding baseline QTcF interval was subtracted from the average QTcF intervals to create a baseline-adjusted average QTcF interval.

Outcome Time Frame:

Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.

Safety Issue:

No

Principal Investigator

Steve Olsen, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

TDM4688g

NCT ID:

NCT00943670

Start Date:

July 2009

Completion Date:

August 2011

Related Keywords:

  • Metastatic Breast Cancer
  • MBC
  • TDM1
  • Armed Herceptin
  • Herceptin
  • Trastuzumab emtansine
  • Breast Neoplasms
  • Disease Progression

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