Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in HER-2 Positive Breast Cancer

Eric Winer, MD

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Herceptin; Drug: Navelbine; Drug: Carboplatin; Drug: Taxotere

Study type: Interventional

Funder types: Other

Identifiers

NCT00148668

03-311

Details and patient eligibility

About

The purpose of this study is to find out what effects the preoperative combination therapies of herceptin/navelbine or herceptin/taxotere/carboplatin will have on patients with early stage HER-2 positive breast cancer.

Full description

Before starting treatment, a clip will be placed via catheter into the tumor bed, so the surgeon can locate the site of the tumor. During clip placement, tissue biopsy will be taken of the tumor. One to two weeks after the first dose of herceptin another biopsy will be performed.

Patients will be placed into one of 2 arms.

Arm 1 receives 12 weeks of herceptin and navelbine. Arm 2 receives 4 cycles of taxotere/carboplatin/herceptin. Arm 2 participants will also receive neulasta (growth factor support) on day 2 of each cycle.

Phase A of Arm 1 is one dose of herceptin followed by an MRI of the affected breast and a second biopsy 1-2 weeks following this dose. Phase B of Arm 1 begins on week 3 and ends on week 14 and involves weekly injections of herceptin and navelbine. Surgery will take place a minimum of 3 weeks after the patients last dose of herceptin and navelbine.

Phase A of Arm 2 is one dose of herceptin followed by an MRI of the affected breast and second biopsy 1-2 weeks following this dose. Phase B of Arm 2 begins on week 3 and ends on week 14 and involves herceptin weekly, taxotere and carboplatin every 3 weeks. Surgery will take place a minimum of 3 weeks after the patients last dose of herceptin, taxotere and carboplatin.

Blood tests will be performed every 3 weeks during pre-operative treatment and every 6 months after surgery.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with stage II or III breast cancer
• HER-2 positive tumors
• Older than 18 years of age
• Eastern Cooperative Oncology Group (ECOG) Performance Status of greater or equal to 1.
• ANC > 1,500/mm3
• Hemoglobin > 9gm/dl
• Platelets > 100,000mm3
• Creatinine < 2mg/dl
• Glucose < 200mg/dl
• Bilirubin < 1.5 x ULN

Exclusion criteria

• Previous treatment with herceptin, taxanes, doxorubicin or other anthracycline-type therapy, navelbine, or platinum-based therapy.
• Pregnant or breast-feeding women
• Serious illness, or medical or psychiatric condition
• Uncontrolled infections
• Active or severe cardiovascular or pulmonary disease
• Patients with left ventricular ejection fraction < 50%
• Peripheral neuropathy of any etiology that exceeds grade 1
• Prior history of malignancy
• Uncontrolled diabetes

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

Arm 1

Active Comparator group

Description:

Herceptin/navelbine

Treatment:

Drug: Navelbine

Drug: Herceptin

Arm 2

Active Comparator group

Description:

Taxotere/carboplatin/herceptin

Treatment:

Drug: Taxotere

Drug: Carboplatin

Drug: Herceptin