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Trastuzumab and Vinorelbine in Advanced Breast Cancer

This study has been terminated.
(Not enough confirmed responses to continue treatment.)
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Genentech, Inc.
Information provided by (Responsible Party):
Ian E. Krop, MD, PhD, Dana-Farber Cancer Institute Identifier:
First received: August 18, 2010
Last updated: August 3, 2016
Last verified: August 2016
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.

Condition Intervention Phase
Breast Cancer
Metastatic Breast Cancer
Drug: trastuzumab
Drug: vinorelbine
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Single Arm, Open Label Study to Evaluate the Efficacy and Safety of Trastuzumab and Vinorelbine in Advanced Breast Cancer Patients With HER2 Negative Primary Tumors and HER2 Positive Circulating Tumor Cells

Resource links provided by NLM:

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: 2 years ]
    To assess the objective response rate of trastuzumab and vinorelbine in patients with metastatic breast cancer with HER2 negative primary tumors and HER2 positive circulating cells.

Secondary Outcome Measures:
  • CTCs [ Time Frame: 2 years ]
    To describe the number of CTCs and the CTCs characteristics before and after therapy, and to explore the correlation of these findings with response.

  • Safety and Tolerability [ Time Frame: 2 years ]
    To further characterize the safety and tolerability of trastuzumab and vinorelbine in this patient population.

Enrollment: 31
Study Start Date: October 2010
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: trastuzumab
    Administered intravenously every 3 weeks.
    Drug: vinorelbine
    Administered intravenously once a week
Detailed Description:
  • Participants will receive two different drugs. Trastuzumab will be administered by vein every 3 weeks. Participants will receive a higher dose of trastuzumab on the first day of treatment followed by a lower dose for subsequent administration. Vinorelbine will be administered by vein once a week.
  • Each treatment cycle lasts 3 weeks during which time participants will be receiving Vinorelbine weekly and Trastuzumab every 3 weeks. Participants will continue to receive Vinorelbine weekly and Trastuzumab every 3 weeks as long as their cancer is not growing and they are not experiencing severe side effects.
  • Circulating tumor cells (CTCs) will be collected at study entry, at 6 weeks or up to one week prior, and when study treatment is stopped.
  • ECHO or MUGA scan is performed at study entry and repeated at 18 weeks and then as needed.
  • CT or MRI will be performed at study entry and then repeated every 6 weeks for the first 18 weeks and then every 12 weeks thereafter. A bone scan or CT/MRI scan of the brain will be performed if the doctor determines this is medically necessary.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic invasive mammary carcinoma. The primary cancer must be HER2 negative by fluorescence in situ hybridization and/or immunohistochemistry.
  • 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.

Exclusion Criteria:

  • 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 ineligible
  • 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 study treatment.
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01185509

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Genentech, Inc.
Principal Investigator: Ian Krop, MD, PhD Dana-Farber Cancer Institute
  More Information

Responsible Party: Ian E. Krop, MD, PhD, Assistant Professor of Medicine, Dana-Farber Cancer Institute Identifier: NCT01185509     History of Changes
Other Study ID Numbers: 10-207
H4913s ( Other Identifier: Genentech, Inc )
Study First Received: August 18, 2010
Last Updated: August 3, 2016

Keywords provided by Dana-Farber Cancer Institute:
HER2 negative
HER2 positive

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on April 24, 2017