A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1, T-DM1) in Combination With Pertuzumab Administered to Patients With Human Epidermal Growth Factor Receptor-2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer Who Have Previously Received Trastuzumab

Completed · Phase 1/Phase 2

Conditions studied: Metastatic Breast Cancer

In brief

This was a multi-institutional, multinational, open-label, single-arm Phase Ib/II study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of trastuzumab emtansine (trastuzumab-MCC-DM1) administered by intravenous (IV) infusion in combination with pertuzumab in patients with human epidermal growth factor receptor-2 (HER2)-positive locally advanced or metastatic breast cancer who had previously received trastuzumab.

Key facts

Study ID

NCT00875979

Run by

Hoffmann-La Roche

People needed

67

Starts

2009-05-01

Expected to finish

2011-08-01

Last updated by the study team

2013-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically documented human epidermal growth factor receptor 2 (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 trastuzumab emtansine (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.

You may not qualify if…

• 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, eg, 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.

Where it is running

• Study site — Boca Raton, Florida, United States
• Study site — Deerfield Beach, Florida, United States
• Study site — Maywood, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Wichita, Kansas, United States
• Study site — Rockville, Maryland, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Brussels, Belgium
• Study site — Vancouver, British Columbia, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Paris, France
• Study site — Villejuif, France
• Study site — Cologne, Germany
• Study site — Aviano, Italy
• Study site — Milan, Italy
• Study site — Barcelona, Spain
• Study site — Valencia, Spain

Full record on ClinicalTrials.gov

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