Preoperative Herceptin and Navelbine for Breast Cancer

January 11, 2019 updated by: Eric P Winer, MD, Dana-Farber Cancer Institute

Preoperative Herceptin and Navelbine in Early Stage, HER-2 Positive Breast Cancer

The purpose of this study is to find out what effects the preoperative combination therapy of herceptin and navelbine have on HER-2 positive breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • As part of the patients pre-treatment evaluation, a clip will be placed within the tumor bed so that the surgeon can find it at the time of surgery. Four biopsies of the tumor will be obtained at the time of the clip placement for further testing at a later date.
  • Depending upon the patient's risk level (as assessed by the treating physician), they will be treated similarly to one of two regimens. The first 8 months of both regimens are the same consisting of 12 weeks of herceptin and navelbine, followed by surgery and then 4 cycles of adriamycin and cytoxan. The treatment following these 8 months will depend upon the health risk to the patient and will be determined by both the patient and treating physician.
  • Group 1: Lower Risk Regimen: Patients in this group will receive 3 phases of treatment. In Phase A they will receive Navelbine and Herceptin intravenously every week for 12 weeks. Upon completion of this therapy they will undergo surgery to remove the tumor. Following surgery there will be a 6 week recovery period where no treatment will be received. In Phase B, patients will receive adriamycin (doxorubicin) and cytoxan (cyclophosphamide) intravenously every 3 weeks for 12 weeks, for a total of 4 cycles. Patients then may or may not receive Phase C (depending upon physicians discretion), during which they will receive herceptin intravenously every 3 weeks for 40 weeks. If the physician decides that the patient needs radiation therapy, it will commence after the completion of adriamycin and cytoxan.
  • Group 2: Higher Risk Regimen: Patients in this group will undergo four different phases of treatment. Phase A is identical to that of Group 1 (herceptin and navelbine for 12 weeks followed by surgery) as is Phase B (adriamycin and cytoxan every 3 weeks for 12 weeks for a total of 4 cycles). Phase C will consist of paclitaxel and herceptin weekly for a total of 12 weeks. If the physician decides that radiation therapy should be performed, it will commence within 6 weeks of the last dose of paclitaxel and herceptin. In Phase D, patients will receive herceptin intravenously every three weeks for 28 weeks.
  • The following procedures and tests will be performed during this study: During Phase A: Every week: blood work; Every 3 weeks: physical exam, tumor assessment and bloodwork. During Phase B: Every 3 weeks; physical exam and blood work. At the start of Phase B and C: physical exam, EKG, MUGA scan or echocardiogram and bloodwork. During Phase C: Every 3 weeks for High risk patients and every 3 months for low risk patients; physical exam and blood work. End of Phase C: MUGA scan or echocardiogram. Phase C and D: every 3 months; physical exam, EGK, MUGA scan or echocardiogram and bloodwork.
  • At the end of the study patients will undergo a physical exam, EKG, MUGA scan or echocardiogram and bloodwork.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • EGOG performance status of 0-1
  • HER2 overexpressing (IHC 3+ or FISH +)
  • Stage II or III breast cancer. Clinical T1N1M) and inflammatory (T4) breast cancer are eligible
  • Patients with metastatic breast cancer (Stage IV) which is limited to supraclavicular and/or infraclavicular node positivity are eligible
  • 18 years of age or older

Exclusion Criteria:

  • Prior therapy with herceptin, paclitaxel or other taxane, doxorubicin or other anthracycline-type chemotherapy, navelbine
  • Pregnant or lactating women
  • Uncontrolled infections, including AIDS
  • History or symptoms diagnostic of systemic connective tissue or inflammatory disease
  • Active or severe cardiovascular or pulmonary disease, including recent myocardial infarction or deep-venous thrombosis/pulmonary embolism, congestive heart failure, uncontrolled hypertension, or steroid-dependent asthma.
  • Left ventricular ejection fraction < 50%
  • Peripheral neuropathy of any etiology that exceeds grade 1
  • Prior history of malignancy treated without curative intent
  • Uncontrolled diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lower Risk Regimen
Drug: Herceptin
Intravenously every week for 12 weeks (weeks 1-12) Intravenously every three weeks for 40 weeks (weeks 32-72)
Drug: Navelbine
Intravenously every week for 12 weeks
Drug: Doxorubicin
Every 3 weeks for 12 weeks
Other Names:
  • adriamycin
Drug: Cyclophosphamide
Intravenously every 3 weeks for 12 weeks
Other Names:
  • Cytoxan
Experimental: Higher Risk Regimen
Drug: Herceptin
Intravenously every week for 12 weeks (weeks 1-12) Intravenously every three weeks for 40 weeks (weeks 32-72)
Drug: Navelbine
Intravenously every week for 12 weeks
Drug: Doxorubicin
Every 3 weeks for 12 weeks
Other Names:
  • adriamycin
Drug: Cyclophosphamide
Intravenously every 3 weeks for 12 weeks
Other Names:
  • Cytoxan
Drug: Paclitaxel
Weekly for 12 weeks (or a similar schedule)
Other Names:
  • Taxol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the complete response rate after preoperative herceptin and navelbine in HER-2 positive breast cancer.
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the safety of herceptin and navelbine in this patient population (either high risk or low risk).
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2001

Primary Completion (Actual)

May 1, 2003

Study Completion (Actual)

May 1, 2003

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 11, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00-273

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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