Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Genentech, Inc.


  • Drug: paclitaxel
  • Drug: pertuzumab [Perjeta]
  • Drug: trastuzumab emtansine [Kadcyla]
  • Drug: paclitaxel
  • Drug: trastuzumab emtansine [Kadcyla]


Phase 1/Phase 2


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

   - 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

   - 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting