Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00136539

Enrollment

Registered

2005-08-29

Start date

1999-03-31

Completion date

2012-03-31

Last updated

2013-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DRUGHerceptin

Given intravenously once weekly for 12 weeks prior to surgery.

DRUGTaxol

Given intravenously every 3 weeks (weeks 1, 4, 7, and 10) before surgery.

DRUGAdriamycin

Given every three weeks for 12 weeks after surgery.

DRUGCytoxan

Given every three weeks for 12 weeks after surgery.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
To examine the safety of Herceptin and Taxol therapy followed by surgery and chemotherapy	3 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026