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A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Trastuzumab-MCC-DM1 (PRO132365) Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Previously Received a Trastuzumab-Containing Regimen


Phase 1
N/A
N/A
Not Enrolling
Both
Metastatic Breast Cancer

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Trial Information

A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Trastuzumab-MCC-DM1 (PRO132365) Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Previously Received a Trastuzumab-Containing Regimen


Inclusion Criteria:



- Histologically documented, incurable, locally advanced or metastatic breast cancer

- Evaluable or measurable HER2-positive disease

- History of progression during or within 60 days after treatment with any prior
trastuzumab-containing chemotherapy regimen for HER2-positive breast cancer

- Previous treatment with chemotherapy for MBC

Exclusion Criteria:

- History of significant cardiac disease, unstable angina, CHF, myocardial infarction,
or ventricular arrhythmia requiring medication

- History of Grade ≥ 3 hypersensitivity reaction to trastuzumab

- History of any toxicity to trastuzumab that resulted in trastuzumab being permanently
discontinued

- Symptomatic brain metastases or any radiation or surgery for brain metastases within
3 months of first study treatment

- Require supplemental oxygen for daily activities

- Grade ≥ 2 peripheral neuropathy

- Bisphosphonate therapy for symptomatic hypercalcemia

- Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic therapy
for the treatment of breast cancer within 4 weeks of first study treatment

- Any experimental therapy within 4 weeks of first study treatment

- Any major surgical procedure within 4 weeks of first study treatment

- History of clinically symptomatic liver disease, including viral or other hepatitis,
current or history of alcoholism, or cirrhosis

- Pregnancy or lactation

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency and nature of Dose-limiting toxicities (DLTs)

Outcome Time Frame:

Through study completion or early study discontinuation

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:

TDM3569g

NCT ID:

NCT00932373

Start Date:

April 2006

Completion Date:

August 2009

Related Keywords:

  • Metastatic Breast Cancer
  • HER2-positive breast cancer
  • MBC
  • Trastuzumab emtansine
  • Herceptin
  • T-DM1
  • Breast Neoplasms

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