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NCT Number: NCT00148668

Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yale Cancer Center, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Herceptin

Drug

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

Other names: Trastuzumab

Navelbine

Drug

Weekly injections given starting week 3 and ending week 14

Other names: vinorelbine

Taxotere

Drug

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

Other names: docetaxel

carboplatin

Drug

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

Other names: paraplatin

Primary outcomes

  1. 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

    Pathological Complete Response is defined as the complete disappearance of invasive tumor in the breast at the time of surgery

Sponsors and collaborators

Lead sponsor

Eric Winer, MD

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
  • Dana-Farber Cancer Institute
  • Massachusetts General Hospital
  • Yale University

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2009
Study completion
2011
First posted
Sep 8, 2005
Registry last updated
Apr 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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