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CLINICAL TRIALS

About Clinical Trials Find a Clinical Trial

CLINICAL TRIALS

About Clinical Trials Find a Clinical Trial

A Study of Trastuzumab Emtansine, Paclitaxel, and Pertuzumab in Patients With HER2-Positive, Locally Advanced or Metastatic Breast Cancer

Trial ID or NCT#

NCT00951665

Status

NOT RECRUITING

Purpose

This Phase Ib-IIa, multi-institutional, open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics and feasibility of trastuzumab emtansine (T-DM1) administered by intravenous (IV) infusion in combination with paclitaxel (and pertuzumab, if applicable) in patients with human epidermal growth factor receptor 2-positive (HER2-positive), locally advanced or metastatic breast cancer.

Official Title

A Phase Ib-IIa, Open-label, Dose-Escalation Study of the Safety, Tolerability and Pharmacokinetics of Trastuzumab Emtansine, Paclitaxel and Pertuzumab Administered Intravenously to Patients With Her2-positive, Locally Advanced or Metastatic Breast Cancer

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years

Sexes Eligible for Study: All

Accepts Healthy Volunteers: No

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 (Phase Ib patients only) - No prior T-DM1 or pertuzumab therapy - Measurable or evaluable disease - Cardiac ejection fraction >=50% by either echocardiogram or multigated acquisition scan - Life expectancy >= 90 days as assessed by the investigator

Exclusion Criteria:

- Fewer 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 are allowed; palliative radiation therapy involving <=25% of marrow-bearing bone is allowed if completed within >= 14 days prior to first study treatment - History of intolerance or hypersensitivity to trastuzumab and/or adverse events related to trastuzumab, murine proteins, or any of the excipients that resulted in trastuzumab being permanently discontinued - Peripheral neuropathy of Grade >= 2 per NCI CTCAE, Version 3.0, at the time of, or within 3 weeks prior to, the first study therapy (Phase Ib patients) - Peripheral neuropathy of Grade >/=1 per NCI CTCAE, Version 3.0, at the time of, or within 3 weeks prior to, the first study therapy (Phase IIa patients) - History of exposure to the following cumulative doses of anthracyclines: Doxorubicin > 500 mg/m^2; Liposomal doxorubicin > 900 mg/m^2; Epirubicin > 720 mg/m^2 - History of clinically significant cardiac dysfunction - Brain metastases that are untreated, or progressive, or have required any type of therapy (including radiation, surgery, or steroids) to control symptoms from brain metastases within 60 days prior to the first study treatment. - History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, basal cell carcinoma, or synchronous or subsequent HER2-positive breast cancer or other malignancy with a similar expected curative outcome

View All Criteria

Investigator(s)

Mark Pegram

Medical oncologist, Breast specialist

Susy Yuan-Huey Hung Professor

Allison W. Kurian, M.D., M.Sc.

Medical oncologist, Breast specialist, Cancer geneticist

Professor of Medicine (Oncology) and of Epidemiology and Population Health

CONTACT

CCTO
(650) 498-7061

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A Study of Trastuzumab Emtansine, Paclitaxel, and Pertuzumab in Patients With HER2-Positive, Locally Advanced or Metastatic Breast Cancer

Trial ID or NCT#

Status

Purpose

Official Title

Eligibility Criteria

Investigator(s)

CONTACT

About this Clinical Trial

Your Message Will Go To

To:

New to MyHealth?

ALREADY HAVE AN ACCESS CODE?

DON'T HAVE AN ACCESS CODE?

NEED MORE DETAILS?

MyHealth for Mobile

WELCOME BACK

A Study of Trastuzumab Emtansine, Paclitaxel, and Pertuzumab in Patients With HER2-Positive, Locally Advanced or Metastatic Breast Cancer

Trial ID or NCT#

Status

Purpose

Official Title

Eligibility Criteria

Investigator(s)

CONTACT

About this Clinical Trial

Your Message Will Go To

To: