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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

Phase 2
18 Years
Open (Enrolling)
Breast Cancer, Metastatic Breast Cancer

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Trial Information

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

- 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

- 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.

Inclusion Criteria:

- 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.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Ian Krop, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

October 2010

Completion Date:

Related Keywords:

  • Breast Cancer
  • Metastatic Breast Cancer
  • HER2 negative
  • HER2 positive
  • Breast Neoplasms



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Dana-Farber Cancer Institute at Faulkner Hospital Boston, Massachusetts  02215