Trastuzumab and Vinorelbine in Advanced Breast Cancer
Phase: Phase 2
Diagnosis: Breast: Early Stage Disease
NCT ID: NCT01185509
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 10-207
The purpose of this research study is to see what effects trastuzumab in combination with vinorelbine has on breast cancer when the participant has circulating tumor cells that are positive for the protein called HER2. Trastuzumab is an FDA approved drug that targets HER2. The drug combination of trastuzumab and vinorelbine is an effective treatment for patients with breast cancers that are positive for HER2. This trial seeks to determine if the combination can also benefit participants whose original breast cancer was HER2 negative but whose circulating tumor cells are HER2 positive.
Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital
Steven Isakoff, MD, PhD,
Massachusetts General Hospital
Ian Krop, MD,
Dana-Farber Cancer Institute
Gerburg Wulf, MD,
Beth Israel Deaconess Medical Center
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute:
Breast Cancer Nursing Team, 617-632-3478
Beth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060
- Histologically or cytologically confirmed metastatic invasive mammary carcinoma. The
primary cancer must be HER2 negative by fluorescence in situ hybridization and/or
- Patients must have CTCs with HER2 amplification by FISH.
- Measurable disease, defined as at least one lesion that can be accurately measured in
at least one dimension as 20mm or greater with conventional techniques of as 10mm or
greater with spiral CT scan.
- Study participants must have either archival primary tumor or metastatic tumor tissue
available to allow analysis to confirm their HER2 status.
- Patients must have received at least 1 prior chemotherapy regimen for metastatic
breast cancer or evidence of disease progression within 6 months of completing
adjuvant chemotherapy. Patients can receive any number of biological or hormonal
regimens and remain eligible.
- 18 years of age or older
- Life expectancy of greater than 3 months
- ECOG Performance Status of 0, 1 or 2
- Normal organ and marrow function as outlined in the protocol
- Women of child-bearing potential and men must agree to use adequate contraception
prior to study entry and for the duration of study participation.
- Participants must have recovered from all reversible toxicities related to prior
therapy before beginning protocol treatment, and may not have any pre-existing
treatment-related toxicities in excess of grade 2
- Participants may not be receiving any other investigational agents while
participating in this study
- Participants may not have received trastuzumab or vinorelbine in the past
- Participants receiving any medications or substances that are inhibitors of
cytochrome P450 isoenzymes in the CYP3A subfamily are ineligible.
- EKG abnormalities of known clinical significance, such as prolonged QT.
- Left ventricular ejection fraction < 50%
- Patients with peripheral neuropathy of any etiology that exceeds grade 1 are
- Uncontrolled intercurrent illness
- Individuals with symptomatic or progressive brain metastases are ineligible.
Subjects with treated brain metastases are eligible if they have no radiographic or
other signs of progression in the brain for 1 month or longer after completion of
local therapy. Any corticosteroid use for brain metastases must have been
discontinued without subsequent appearance of symptoms for more than 4 weeks prior to
- Individuals with active second malignancy are ineligible. Patients that are
disease-free from a previously treated non-breast malignancy and have a 20% or less
chance of recurrence are eligible.
- Pregnant or breast feeding women
- HIV-positive individuals on combination antiretroviral therapy