Clinical trial NCT00136539: Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer
Official title: Neoadjuvant Therapy With Herceptin and Taxol for Stage II/III Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Breast Cancer
Early Stage Breast Cancer
HER2-positive
HER2-positive breast cancer
Herceptin
Taxol
Stage II Breast Cancer
Stage III Breast Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
name: Genentech, Inc.
name: Bristol-Myers Squibb
name: Massachusetts General Hospital
name: Beth Israel Deaconess Medical Center
name: Harvard Vanguard Medical Associates
name: Brigham and Women's Hospital
First posted: 2005-08-29
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness and safety of administering Herceptin in combination with Taxol (paclitaxel) in the treatment of women with HER2-positive, early stage breast cancer prior to surgery.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: To determine the response of HER2-positive breast cancer to treatment with Herceptin and Taxol prior to surgery
Secondary outcomes:
measure: To examine the safety of Herceptin and Taxol therapy followed by surgery and chemotherapy
timeFrame: 3 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Harold Burstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: