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An Open-label, Multi-center Study of the Safety and Tolerability of the Combination of Trastuzumab-MCC-DM1 (T-DM1) With Docetaxel, and Potentially Pertuzumab, for Treatment for Patients With Advanced Breast Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

Thank you

Trial Information

An Open-label, Multi-center Study of the Safety and Tolerability of the Combination of Trastuzumab-MCC-DM1 (T-DM1) With Docetaxel, and Potentially Pertuzumab, for Treatment for Patients With Advanced Breast Cancer


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- ECOG performance status 0-1 (ECOG performance status of 2 will be allowed if only due
to debilitating bone disease)

- HER2-positive metastatic or locally advanced breast cancer

- For MBC (metastatic breast cancer) patients:

- documented metastatic or inoperable locally advanced (without meeting LABC criteria)
disease, amenable for treatment with docetaxel

- history of disease progression within 3 months prior to study entry

- For LABC (locally advanced breast cancer) patients:

- newly diagnosed locally advanced breast cancer, Stage IIIA-IIIC (AJCC staging system)

Exclusion Criteria:

- Pregnant or lactating women

- Significant cardiac disease

- Inadequate bone marrow, liver or renal function

- For MBC patients:

- patients must not have received radiotherapy for the treatment of metastatic or
locally recurrent/advanced disease other than for the relief of pain in progressing
metastatic bone lesions and/or brain metastases

- brain metastases that are untreated, symptomatic or require therapy to control
symptoms

- For LABC patients:

- clinically or radiologically detectable metastasis (M1 disease)

- patients for whom surgery as primary intent procedure is the best option to treat
their disease

- previous systemic or loco regional anti-cancer therapy for locally advanced disease

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose-limiting toxicities

Outcome Time Frame:

approximately 4 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

BP22572

NCT ID:

NCT00934856

Start Date:

July 2009

Completion Date:

September 2013

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Austin, Texas  78705
Charlotte, North Carolina