Vinorelbine With Trastuzumab Emtansine in Pre-Treated HER2-Positive Metastatic Breast Cancer

Stopped early · Phase 1/Phase 2

Conditions studied: Breast Cancer, Metastatic Breast Cancer

In brief

The study proposes to evaluate the safety and efficacy of the combination of trastuzumab emtansine (T-DM1) and vinorelbine in HER2+ metastatic breast cancer patients.

Key facts

Study ID

NCT02658084

Run by

University of Miami

People needed

2

Starts

2017-04-12

Expected to finish

2018-10-11

Last updated by the study team

2019-04-17

Who can join

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

You may qualify if…

• Histologically or cytologically documented breast cancer.
• Metastatic or unresectable locally advanced/recurrent breast cancer.
• HER2-positive disease documented as: Immunohistochemistry (IHC) 3+ positive, and/or Fluorescence in situ hybridization (FISH) ≥ 2.0, and/or gene copy number greater than 6, on previously collected tumor or metastatic site. IHC testing, FISH assay(s), and gene copy number may all have been performed; however, a positive result from only one of the above is required for eligibility.
• Documented disease progression on the last regimen by radiographic measurement (progression demonstrated by tumor markers only is unacceptable).
• Documented disease progression (by investigator assessment) after at least one regimen of HER2-directed therapy in the metastatic or unresectable locally advanced/recurrent setting.
• For patients with hormone receptor-positive disease: disease progression or recurrence in any setting on prior hormonal therapy, given with or without HER2 directed therapy.
• Measurable or bone only disease.
• Prior treatment with a taxane, in the neoadjuvant, adjuvant, locally advanced or metastatic setting.
• A minimum of 6 weeks of prior trastuzumab for the treatment of metastatic or unresectable locally advanced/recurrent disease is required.
• Prior use of Pertuzumab in any setting is permitted (but not required).
• Prior use of Lapatinib in any setting is permitted (but not required).
• Age ≥ 18 years
• Life expectancy ≥ 3 months
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. See Appendix C for details.
• Patients must have normal organ and marrow function as defined below:
• absolute neutrophil count (ANC) >1,500 cells/mm3
• platelets >100,000 cells/mm3
• hemoglobin > 9.0 g/dL (Patients are permitted to receive transfused red blood cells to achieve this level.)
• total bilirubin ≤1.5 X institutional upper limit of normal (ULN) [Note: For patients with previously documented Gilbert's syndrome, total bilirubin ≤ 3 mg/dL.]
• Aspartate aminotransferase (AST/SGOT) ≤ 2.5 X ULN
• Alanine aminotransferase (ALT/SGPT) ≤ 2.5 X ULN
• alkaline phosphatase (alk phos) ≤ 2.5 X ULN
• serum creatinine < 1.5 X ULN
• International normalized ratio (INR) < 1.5 X ULN
• Left ventricular ejection fraction (LVEF) ≥ 50% by either echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA).

You may not qualify if…

• Chemotherapy ≤21 days prior to first dose of study treatment
• If last dose of trastuzumab was:
• 6mg/kg then ≤21 days prior to first dose of study treatment
• 4mg/kg then ≤14 days prior to first dose of study treatment
• 2mg/kg then ≤7 days prior to first dose of study treatment
• Lapatinib ≤14 days prior to first dose of study treatment
• Pertuzumab ≤21 days prior to first dose of study treatment
• Hormone therapy ≤7 days prior to first dose of study treatment
• Investigational therapy or any other such experimental therapy ≤28 days prior to first dose of study treatment
• Prior treatment with trastuzumab emtansine, (on or off a study protocol)
• Prior use of vinorelbine (in any setting).
• Previous radiotherapy for the treatment of unresectable, locally advanced, recurrent or metastatic breast cancer is not allowed if:
• The last fraction of radiotherapy has been administered within 14 days prior to study enrollment
• More than 25% of marrow-bearing bone has been irradiated
• Brain metastases that are untreated or symptomatic, or require any radiation, surgery, or continued steroid therapy to control symptoms from brain metastases within 14 days of study enrollment.
• History of intolerance (including Grade 3 or 4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins.
• History of exposure to the following cumulative doses of anthracyclines:
• Doxorubicin ≥550mg/m2
• Liposomal doxorubicin >500 mg/m2
• Epirubicin >900 mg/m2
• Mitoxantrone > 120 mg/m2
• If another anthracycline, or more than one anthracycline, has been used, the cumulative dose must not exceed the equivalent of ≥550 mg/m2 doxorubicin.
• Current peripheral neuropathy of Grade ≥3 per the NCI CTCAE, v4.0
• The patient has not recovered from any other acute toxicity (to Grade ≤1 as per NCI CTCAE v4.03) prior to study enrollment.
• History of other malignancy within the last 3 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with a similar outcome.

Where it is running

• University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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