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| Overall Recruitment Status: Enrollment complete |
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| Official Title |
| A Randomized, Double-Blind, Phase III Trial of Taxane/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer
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| Region |
Sponsors |
| California - Northern |
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| Acronym |
NCT No. |
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NCT03199885 |
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| Study Type |
Phase |
| Clinical Trial |
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| Purpose |
| This randomized phase III trial studies how well paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab works in treating patients with breast cancer that has spread to other parts of the body (metastatic). Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab is a form of "targeted therapy" because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Monoclonal antibodies, such as pertuzumab, may interfere with the ability of cancer cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab may kill more tumor cells.
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| Detailed Description |
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- The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines
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The trial is open to female and male patients
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Patients must be >= 18 years old
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Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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Histologically confirmed adenocarcinoma of the breast with locally recurrent, unresectable disease or metastatic disease outside the central nervous system (CNS) confirmed as described below
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- eligible patients include those with either:
De novo metastatic disease presenting without prior history of HER2-positive breast cancer:
Diagnosis should have been made from a biopsy of a metastatic disease site, but biopsy from the breast primary or involved regional lymph nodes is acceptable if biopsy of the metastatic sites was thought to carry excessive risk for the patient
Locally recurrent or metastatic disease following prior therapy for early breast cancer:
Diagnosis must have been made from the biopsy of the locally recurrent or metastatic disease
There must be an interval of >= 6 months between completion of neoadjuvant/adjuvant HER2-targeted therapy and documentation of locally recurrent or metastatic HER2-positive disease by biopsy
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- Patients with brain metastases are excluded if they meet ANY of the following criteria:
Symptoms from brain metastases have not resolved prior to study entry
Five or more clearly identified foci of metastases to the brain
Largest unexcised tumor exceeds 3 cm
Spinal cord metastases
Medical Oncologist plans to employ HER2-directed tyrosine kinase inhibitor as component of systemic therapy
Metastatic disease limited to CNS
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Leptomeningeal carcinomatosis
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History of systemic anti-cancer therapy (e.g., chemotherapy, targeted therapy) for metastatic breast cancer (MBC) except as described in inclusion criteria
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History of exposure to cumulative doses of doxorubicin greater than 360 mg per square meter of body-surface area or its equivalent
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Prior treatment with mTOR inhibitors or CDK 4/6 inhibitors in combination with endocrine therapy for treatment of metastatic disease
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- Obstetrics and Gynecology
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