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A Phase Ib/II, Open-Label Study of the Safety, Tolerability, and Efficacy of Trastuzumab-MCC-DM1 in Combination With Pertuzumab Administered Intravenously to Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Previously Received Trastuzumab


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

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Trial Information

A Phase Ib/II, Open-Label Study of the Safety, Tolerability, and Efficacy of Trastuzumab-MCC-DM1 in Combination With Pertuzumab Administered Intravenously to Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Previously Received Trastuzumab


Inclusion Criteria:



- Histologically documented HER2-positive locally advanced or metastatic breast cancer

- Tumor tissue blocks or 15-20 unstained tissue slides for confirmatory central
laboratory HER2 status testing and other exploratory assessments

- Prior trastuzumab in any line of therapy

- No prior T-DM1 or pertuzumab therapy

- Measurable disease

- For women of childbearing potential, agreement to use an effective form of
contraception and to continue its use for the duration of the study

- Life expectancy >= 90 days

Exclusion Criteria:

- Less than 21 days since the last anti-tumor therapy, including chemotherapy,
biologic, experimental, immune, hormonal or radiotherapy for the treatment of breast
cancer, with the following exceptions: hormone-replacement therapy or oral
contraceptives; palliative radiation therapy involving =< 25% of marrow-bearing bone
if administered >= 14 days prior to first study treatment

- History of intolerance or hypersensitivity to trastuzumab and/or adverse events
related to trastuzumab that resulted in trastuzumab being permanently discontinued

- Peripheral neuropathy of Grade >= 2

- History of clinically significant cardiac dysfunction

- Current severe, uncontrolled systemic disease (e.g., clinically significant
cardiovascular, pulmonary, or metabolic disease)

- Brain metastases that are untreated, progressive, or have required any type of
therapy to control symptoms from brain metastases within 60 days of the first study
treatment

- History of other malignancy within the last 5 years, except for appropriately treated
carcinoma in situ of the cervix, non-melanoma skin carcinoma, or other malignancy
with a similar expected curative outcome

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Adverse events or changes in physical findings and clinical laboratory results during and following study drug administration that result in dose modification, dose delay, or discontinuation of T-DM1 and/or pertuzumab

Outcome Time Frame:

Up to study discontinuation or up to 1 year after the last patient is enrolled

Safety Issue:

No

Principal Investigator

Elaine K. Wong, M.Sc., M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

TDM4373g

NCT ID:

NCT00875979

Start Date:

May 2009

Completion Date:

January 2012

Related Keywords:

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

Name

Location

Hinsdale, Illinois  60521
Miami, Florida  33176
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Kansas City, Kansas  66160
Baltimore, Maryland  21287
Charlotte, North Carolina  
Indianapolis, Indiana