A Randomized Phase III Study of Trastuzumab (Herceptin) in Combination With Either Vinorelbine (Navelbine), or Taxane-based Chemotherapy in Patients With HER2 Overexpressing Metastatic Breast Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Stage IV Breast Cancer

Thank you

Trial Information

A Randomized Phase III Study of Trastuzumab (Herceptin) in Combination With Either Vinorelbine (Navelbine), or Taxane-based Chemotherapy in Patients With HER2 Overexpressing Metastatic Breast Cancer


- All patients will receive trastuzumab then be randomized into one of two arms. Arm A:
Trastuzumab in combination with weekly vinorelbine and Arm B: Trastuzumab in
combination with a weekly taxane-based regimen, either paclitaxel or docetaxel, chosen
at the discretion of the investigator.

- Treatment is administered on an outpatient basis. Trastuzumab is administered weekly.
There is a one-time loading dose for the first week of the first cycle. For that
initial treatment, only, the trastuzumab dose is 4mg/kg. The dose for all subsequent
weekly trastuzumab treatments is 2mg/kg.

- Arm A: vinorelbine is administered every week and the dose is adjusted based on the
absolute neutrophil count for that week. Vinorelbine is given after trastuzumab.

- Arm B: Either paclitaxel given weekly (dose bases on absolute neutrophil count) or
docetaxel given on weeks 1,2,3,5,6,7 of each 8-week cycle (dose based upon absolute
neutrophil count). Patients on paclitaxel will also receive dexamethasone,
diphenhydramine and ranitidine to help prevent allergic or hypersensitivity reactions.
Patients on docetaxel will receive dexamethasone to help reduce fluid retention or
edema.

- Every 8 weeks the patients cancer will be re-evaluated to see if the treatment is
working. If the treatment appears to be working, treatment will continue. Standard
radiological testing (x-rays, CT scan, radioactive drug scans, or MRI's) will be used
to follow the disease treatment.

- Heart function will be measured after 16 weeks to be sure it is safe to continue
treatment.

- Every 8 weeks, patients' will be asked to complete a brief written survey that asks
about symptoms and side effects.

- Patients' will remain on the treatment as long as there is no disease progression or
unacceptable side effects.


Inclusion Criteria:



- Histologically or cytologically confirmed invasive breast cancer, with stage IV
disease

- Tumors must be HER2 overexpressing

- Measurable disease, defined as a least one lesion that can be accurately measured in
at least one dimension

- 18 years of age or older

- Life expectancy of greater than 6 months

- ECOG performance status of 0-2

- ANC count > 1,500/mm3

- Platelets > 100,000/mm3

- Total bilirubin < 1.5 mg/dl

- AST/ALT < 115 U/I

- Creatinine < 2.0 mg/dl

- Glucose < 200 mg/dl

- LVEF > 50%

Exclusion Criteria:

- Prior chemotherapy or prior trastuzumab therapy for metastatic breast cancer

- Concurrent hormonal therapy, chemotherapy, or radiation treatments

- Pregnant or lactating women

- Known brain metastases or leptomeningeal carcinomatosis

- History of grade 3 or 4 allergic reactions attributed to compounds of similar
chemical or biologic composition to the agents in this study

- Pre-existing neuropathy from any cause in excess of grade 1

- Uncontrolled intercurrent illness

- History of other non-breast cancer malignancy except for carcinoma in situ of the
cervix or non-melanoma skin cancer

- Patients taking macrolide antibiotics, ketoconazole, or AZT

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To compare the overall response rate for patients receiving trastuzumab in combination with either vinorelbine or taxane-based chemotherapy.

Principal Investigator

Harold Burstein, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

01-087

NCT ID:

NCT00146549

Start Date:

August 2001

Completion Date:

December 2007

Related Keywords:

  • Breast Cancer
  • Stage IV Breast Cancer
  • HER2-positive Breast cancer
  • HER2 overexpressing
  • trastuzumab
  • Herceptin
  • vinorelbine
  • Navelbine
  • Taxotere
  • taxol
  • Breast Neoplasms

Name

Location
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617