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
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Herceptin
Drug: Navelbine
Drug: Taxotere
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Early Stage, HER-2 Positive Breast Cancer

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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


Enrollment: 81
Study Start Date: December 2003
Study Completion Date: August 2011
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Herceptin/navelbine
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
Active Comparator: Arm 2
Taxotere/carboplatin/herceptin
Drug: Herceptin
One dose given followed by an MRI, then weekly injections beginning week 3 and ending week 14.
Other Name: Trastuzumab
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148668

Locations
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06520
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Eric Winer, MD
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Yale University
Investigators
Principal Investigator: Eric Winer, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Eric Winer, MD, Chief Division of Women's Cancers, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00148668     History of Changes
Other Study ID Numbers: 03-311
Study First Received: September 7, 2005
Results First Received: December 19, 2012
Last Updated: March 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
HER-2 Positive Breast Cancer
herceptin
navelbine
taxotere
carboplatin
Early stage Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vinorelbine
Docetaxel
Trastuzumab
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014