Preoperative Herceptin and Navelbine for Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Dana-Farber Cancer Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00148681
First received: September 7, 2005
Last updated: October 30, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Stage II Breast Cancer
Stage III Breast Cancer
Drug: Herceptin
Drug: Navelbine
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Paclitaxel
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: Preoperative Herceptin and Navelbine 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:
  • To assess the complete response rate after preoperative herceptin and navelbine in HER-2 positive breast cancer. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the safety of herceptin and navelbine in this patient population (either high risk or low risk). [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 49
Study Start Date: May 2001
Estimated Study Completion Date: April 2010
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: adriamycin
Drug: Cyclophosphamide
Intravenously every 3 weeks for 12 weeks
Other Name: 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 Name: adriamycin
Drug: Cyclophosphamide
Intravenously every 3 weeks for 12 weeks
Other Name: Cytoxan
Drug: Paclitaxel
Weekly for 12 weeks (or a similar schedule)
Other Name: Taxol

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00148681

Locations
United States, Massachusetts
Dana-Farber Cancer Center
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Investigators
Principal Investigator: Lyndsay Harris, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Lyndsay Harris, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00148681     History of Changes
Other Study ID Numbers: 00-273
Study First Received: September 7, 2005
Last Updated: October 30, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
HER-2 Positive breast cancer
herceptin
navelbine

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Liposomal doxorubicin
Vinorelbine
Trastuzumab
Doxorubicin
Paclitaxel
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 28, 2014