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

This study has been completed.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Yale University
Information provided by (Responsible Party):
Eric Winer, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00148668
First received: September 7, 2005
Last updated: March 29, 2013
Last verified: March 2013

September 7, 2005
March 29, 2013
December 2003
January 2009   (final data collection date for primary outcome measure)
Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Pathological Complete Response is defined as the complete disappearance of invasive tumor in the breast at the time of surgery
To determine the response after preoperative therapy with herceptin/navelbine versus taxotere/carboplatin/herceptin in patients with HER-2 positive early breast cancer.
Complete list of historical versions of study NCT00148668 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in HER-2 Positive Breast Cancer
A Randomized Phase II Study of Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Early Stage, HER-2 Positive Breast Cancer

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Herceptin
    One dose given followed by an MRI, then weekly injections beginning week 3 and ending week 14.
    Other Name: Trastuzumab
  • Drug: Navelbine
    Weekly injections given starting week 3 and ending week 14
    Other Name: vinorelbine
  • Drug: Taxotere
    Given every three weeks starting week 3 and ending on week 14
    Other Name: docetaxel
  • Drug: Carboplatin
    Given every three weeks starting week 3 and ending on week 14
    Other Name: paraplatin
  • Active Comparator: Arm 1
    Herceptin/navelbine
    Interventions:
    • Drug: Herceptin
    • Drug: Navelbine
  • Active Comparator: Arm 2
    Taxotere/carboplatin/herceptin
    Interventions:
    • Drug: Herceptin
    • Drug: Taxotere
    • Drug: Carboplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
August 2011
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00148668
03-311
Yes
Eric Winer, MD, Dana-Farber Cancer Institute
Eric Winer, MD
  • Dana-Farber Cancer Institute
  • Brigham and Women's Hospital
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Yale University
Principal Investigator: Eric Winer, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP