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

NCT ID: NCT00148668

Last Updated: 2013-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2011-08-31

Brief Summary

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.

Detailed 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Herceptin/navelbine

Group Type: ACTIVE_COMPARATOR

Herceptin

Intervention Type: DRUG

One dose given followed by an MRI, then weekly injections beginning week 3 and ending week 14.

Navelbine

Intervention Type: DRUG

Weekly injections given starting week 3 and ending week 14

Arm 2

Taxotere/carboplatin/herceptin

Group Type: ACTIVE_COMPARATOR

Herceptin

Intervention Type: DRUG

One dose given followed by an MRI, then weekly injections beginning week 3 and ending week 14.

Taxotere

Intervention Type: DRUG

Given every three weeks starting week 3 and ending on week 14

Carboplatin

Intervention Type: DRUG

Given every three weeks starting week 3 and ending on week 14

Interventions

Herceptin

One dose given followed by an MRI, then weekly injections beginning week 3 and ending week 14.

Intervention Type: DRUG

Navelbine

Weekly injections given starting week 3 and ending week 14

Intervention Type: DRUG

Taxotere

Given every three weeks starting week 3 and ending on week 14

Intervention Type: DRUG

Carboplatin

Given every three weeks starting week 3 and ending on week 14

Intervention Type: DRUG

Other Intervention Names

Trastuzumab; vinorelbine; docetaxel; paraplatin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: collaborator

Eric Winer, MD

OTHER

Sponsor Role: lead

Responsible Party

Eric Winer, MD

Chief Division of Women's Cancers

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Eric Winer, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Yale Cancer Center

New Haven, Connecticut, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

03-311

Identifier Type: -

Identifier Source: org_study_id