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

Breast Cancer Clinical Trial

Official title:

A Randomized Phase II Study of Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Early Stage, HER-2 Positive Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00148668
• Other study ID #: 03-311
• Status: Completed
• Phase: Phase 2
• First received: September 7, 2005
• Last updated: March 29, 2013
• Start date: December 2003
• Est. completion date: August 2011

Study information

• Verified date: March 2013
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: August 2011
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Herceptin
One dose given followed by an MRI, then weekly injections beginning week 3 and ending week 14.
• Navelbine
Weekly injections given starting week 3 and ending week 14
• Taxotere
Given every three weeks starting week 3 and ending on week 14
• Carboplatin
Given every three weeks starting week 3 and ending on week 14

Locations

Country	Name	City	State
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	Yale Cancer Center	New Haven	Connecticut

Sponsors (6)

Lead Sponsor	Collaborator
Eric Winer, MD	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital, Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer	Pathological Complete Response is defined as the complete disappearance of invasive tumor in the breast at the time of surgery	12 weeks	No