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Preoperative Herceptin and Navelbine in Early Stage, HER-2 Positive Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer

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Trial Information

Preoperative Herceptin and Navelbine in Early Stage, HER-2 Positive Breast Cancer

- As part of the patients pre-treatment evaluation, a clip will be placed within the
tumor bed so that the surgeon can find it at the time of surgery. Four biopsies of the
tumor will be obtained at the time of the clip placement for further testing at a later

- Depending upon the patient's risk level (as assessed by the treating physician), they
will be treated similarly to one of two regimens. The first 8 months of both regimens
are the same consisting of 12 weeks of herceptin and navelbine, followed by surgery and
then 4 cycles of adriamycin and cytoxan. The treatment following these 8 months will
depend upon the health risk to the patient and will be determined by both the patient
and treating physician.

- Group 1: Lower Risk Regimen: Patients in this group will receive 3 phases of
treatment. In Phase A they will receive Navelbine and Herceptin intravenously every
week for 12 weeks. Upon completion of this therapy they will undergo surgery to remove
the tumor. Following surgery there will be a 6 week recovery period where no treatment
will be received. In Phase B, patients will receive adriamycin (doxorubicin) and
cytoxan (cyclophosphamide) intravenously every 3 weeks for 12 weeks, for a total of 4
cycles. Patients then may or may not receive Phase C (depending upon physicians
discretion), during which they will receive herceptin intravenously every 3 weeks for
40 weeks. If the physician decides that the patient needs radiation therapy, it will
commence after the completion of adriamycin and cytoxan.

- Group 2: Higher Risk Regimen: Patients in this group will undergo four different
phases of treatment. Phase A is identical to that of Group 1 (herceptin and navelbine
for 12 weeks followed by surgery) as is Phase B (adriamycin and cytoxan every 3 weeks
for 12 weeks for a total of 4 cycles). Phase C will consist of paclitaxel and
herceptin weekly for a total of 12 weeks. If the physician decides that radiation
therapy should be performed, it will commence within 6 weeks of the last dose of
paclitaxel and herceptin. In Phase D, patients will receive herceptin intravenously
every three weeks for 28 weeks.

- The following procedures and tests will be performed during this study: During Phase
A: Every week: blood work; Every 3 weeks: physical exam, tumor assessment and
bloodwork. During Phase B: Every 3 weeks; physical exam and blood work. At the start
of Phase B and C: physical exam, EKG, MUGA scan or echocardiogram and bloodwork.
During Phase C: Every 3 weeks for High risk patients and every 3 months for low risk
patients; physical exam and blood work. End of Phase C: MUGA scan or echocardiogram.
Phase C and D: every 3 months; physical exam, EGK, MUGA scan or echocardiogram and

- At the end of the study patients will undergo a physical exam, EKG, MUGA scan or
echocardiogram and bloodwork.

Inclusion Criteria:

- EGOG performance status of 0-1

- HER2 overexpressing (IHC 3+ or FISH +)

- Stage II or III breast cancer. Clinical T1N1M) and inflammatory (T4) breast cancer
are eligible

- Patients with metastatic breast cancer (Stage IV) which is limited to supraclavicular
and/or infraclavicular node positivity are eligible

- 18 years of age or older

Exclusion Criteria:

- Prior therapy with herceptin, paclitaxel or other taxane, doxorubicin or other
anthracycline-type chemotherapy, navelbine

- Pregnant or lactating women

- Uncontrolled infections, including AIDS

- History or symptoms diagnostic of systemic connective tissue or inflammatory disease

- Active or severe cardiovascular or pulmonary disease, including recent myocardial
infarction or deep-venous thrombosis/pulmonary embolism, congestive heart failure,
uncontrolled hypertension, or steroid-dependent asthma.

- Left ventricular ejection fraction < 50%

- Peripheral neuropathy of any etiology that exceeds grade 1

- Prior history of malignancy treated without curative intent

- Uncontrolled diabetes

Type of Study:


Study Design:

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

Outcome Measure:

To assess the complete response rate after preoperative herceptin and navelbine in HER-2 positive breast cancer.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Lyndsay Harris, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

May 2001

Completion Date:

April 2010

Related Keywords:

  • Breast Cancer
  • Stage II Breast Cancer
  • Stage III Breast Cancer
  • HER-2 Positive breast cancer
  • herceptin
  • navelbine
  • Breast Neoplasms



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