Neoadjuvant Therapy With Herceptin and Taxol for Stage II/III Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

Neoadjuvant Therapy With Herceptin and Taxol for Stage II/III Breast Cancer


Patients will receive Herceptin intravenously once weekly for 12 weeks, and Taxol
intravenously every 3 weeks (week 1, week 4, week 7 and week 10).

After 12 weeks of treatment, breast surgery will be performed (either a lumpectomy or a
mastectomy).

Once patients have recovered from the surgery, they will receive adriamycin and cytoxan
every 3 weeks for 4 cycles (12 weeks total).

After Herceptin and Taxol therapy, tumor assessment will be performed along with an
echocardiogram and mammogram.

At the time of surgery, re-assessment of the tumor will be done.

Blood work will be performed on day one of each chemotherapy cycle.


Inclusion Criteria:



- Patients must have Stage II or III histologically diagnosed breast cancer

- Primary invasive breast cancers that overexpress the HER2/neu oncogene

- Age older than 18 years

- Eastern Cooperative Oncology Group (ECOG) performance status of < 1

- White blood cell (WBC) > 4000/mm3

- Platelet count > 100,000/mm3

- Bilirubin < 1 x upper limit of normal (ULN)

- SGOT < 1 x ULN

- Creatinine < 1.5mg/dl

- Normal cardiac function and electrocardiogram (EKG) showing absence of ischemic
changes or ventricular hypertrophy

Exclusion Criteria:

- Excisional biopsy, sentinel node dissection or axillary node dissection.

- Prior history of breast cancer unless: diagnosed at least 2 years ago, present cancer
is not in a previously irradiated breast, no prior therapy with anthracycline or
taxane, no prior high-dose chemotherapy with stem cell or bone marrow transplant.

- Pregnant or breast-feeding women

- Uncontrolled infection

- Active or severe cardiovascular or pulmonary disease

- Peripheral neuropathy of any etiology that exceeds grade 1

- Prior history of malignancy treated without curative intent

- Uncontrolled diabetes

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the response of HER2-positive breast cancer to treatment with Herceptin and Taxol prior to surgery

Outcome Time Frame:

TBD

Safety Issue:

No

Principal Investigator

Harold Burstein, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

98-222

NCT ID:

NCT00136539

Start Date:

March 1999

Completion Date:

March 2012

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Early Stage Breast Cancer
  • HER2-positive
  • HER2-positive breast cancer
  • Herceptin
  • Taxol
  • Stage II Breast Cancer
  • Stage III Breast Cancer
  • Breast Neoplasms

Name

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