Status:
TERMINATED
Phase 2 Study of Standard Chemotherapy With Trastuzumab, Plus or Minus Pertuzumab, for Pre-treated Metastatic Breast Cancer
Lead Sponsor:
US Oncology Research
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Breast Neoplasms
Malignant Tumor of the Breast
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This randomized phase 2 study will seek to determine the effectiveness of chemotherapy (physician's choice of vinorelbine, taxane \[paclitaxel, docetaxel or nab paclitaxel\] or capecitabine) plus tras...
Detailed Description
The current preferred first-line therapy for patients with HER2-overexpressing metastatic breast cancer (MBC) is a taxane plus trastuzumab plus pertuzumab, based on results from the CLEOPATRA trial. F...
Eligibility Criteria
Inclusion
- Female, Age ≥ 18 years
- Histologic or cytologic confirmation of human epidermal growth factor receptor 2 (HER2)-positive breast cancer according to most recent biopsy (local testing permitted)
- Measurable or evaluable metastatic disease by Response Evaluation Criteria in Solid Tumors (RECIST) (v1.1)
- Previous treatment with ado-trastuzumab emtansine (T-DM1) for metastatic disease
- a. Prior therapy with pertuzumab is allowed but not required
- At least 1 but no more than 3 prior chemotherapy regimens for metastatic breast cancer (MBC)
- Life expectancy \> 6 months
- Eastern Cooperative Group (ECOG) performance status ≤ 2
- Left Ventricular Ejection Fraction (LVEF) ≥ 50% at baseline as determined by either echocardiogram (ECHO) or Multi Gated Acquisition Scan (MUGA) and within normal limits per institutional guidelines
- Adequate bone marrow function as indicated by the following:
- Absolute Neutrophil Count (ANC) ≥1500/uL (or 1500 per microliter)
- Platelets ≥100,000/uL
- Hemoglobin \>9 g/dL
- Adequate renal function, as indicated by creatinine \<1.5 times upper limit of normal (ULN)
- Adequate liver function, as indicated by bilirubin \<1.5 times ULN
- Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) \<2 x ULN unless liver metastases are present in which case AST and ALT up to 5.x ULN are allowed
- Negative serum pregnancy test within 72 hours before starting study medications for women of childbearing potential
- Women of childbearing potential must be willing to use an acceptable form of birth control (ie, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study Note: Women are considered postmenopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms), or if they have undergone surgical sterilization.
- Signed informed consent obtained prior to any screening procedures.
Exclusion
- Patients will be excluded from the study based on the following criteria:
- Prior treatment in the metastatic setting with the agent chosen as physician's choice of chemotherapy
- Active infection
- Uncontrolled central nervous system metastases, defined as clinical or radiologic evidence of progression of brain metastases or clinical signs of leptomeningeal disease
- a. Patients with treated brain metastases are eligible provided they do not have clinical or radiologic evidence of disease progression and have been off of dexamethasone for at least 3 weeks
- Patient is pregnant or lactating
- Prior chemotherapy within the last 3 weeks (last 6 weeks for nitrosureas/mitomycin)
- Prior radiation therapy within the last 2 weeks; prior radiation therapy to indicator lesion (unless objective disease recurrence or progression within the radiation portal has been documented since completion of radiation).
- Requirement for chronic steroid therapy with a requirement for \> 5mg/day of prednisone or the equivalent.
- a. Treatment with physiologic doses of hydrocortisone up to 20 mg daily (QD) is allowed.
- Requirement for immunosuppressive therapy, such as those used to treat autoimmune disease.
- Concomitant malignancies or previous malignancies within the last 3 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias
- Ejection fraction \<50% or below the lower limit of the institutional normal range, whichever is lower
- Known hypersensitivity to trastuzumab or pertuzumab
- Serious medical or psychiatric limitations likely to interfere with participation in this study.
- Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs, resulting in dyspnea at rest or requiring supplemental oxygen
- Patient is currently part of or has participated in any clinical trial of an investigational agent within 1 month prior to enrollment in this study.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT02229149
Start Date
December 1 2014
End Date
January 1 2022
Last Update
December 2 2022
Active Locations (1)
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1
19 Sites
Multiple Locations, Texas, United States