Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Genentech, Inc.
Information provided by (Responsible Party):
Eric Winer, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00542451
First received: October 9, 2007
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to find out what effect the postoperative combination of therapies: trastuzumab (herceptin) and paclitaxel (taxol) will have on breast cancer recurrence. A combination of trastuzuamb and chemotherapy has been used in women with node positive and high risk node negative disease. This tests utilizes a well tolerated regimen of weekly paclitaxel and trastuzumab in women with T1, node negative tumors that are HER2 positive. We would like to determine how effective this drug combination is when used in women with early stage breast cancer, as well as to better define the side effects of this treatment.


Condition Intervention Phase
Breast Cancer
Carcinoma of the Breast
Drug: Paclitaxel
Drug: Trastuzumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Evaluate disease free survival (DFS) rate in patients with node-negative HER2-positive breast cancer with tumors less than or equal to 3cm treated with adjuvant trastuzumab and paclitaxel [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Describe DFS in patient groups defined by tumor size and hormone receptor status. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Evaluate the incidence of grade III/IV cardiac left ventricular dysfunction from adjuvant trastuzumab and paclitaxel [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Evaluate the incidence of grade III/IV neurotoxicity associated with adjuvant paclitaxel [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Evaluate Topoisomerase II, cMYC, and p53 expression, and correlate with event rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Evaluate P13K mutations and PTEN alterations in a subset of patients and correlate events with the presence or absence of these mutations/alterations [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Enrollment: 420
Study Start Date: October 2007
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Paclitaxel
    Every week for 12 weeks
    Other Name: Taxol
    Drug: Trastuzumab
    Once a week for twelve weeks Then once a week or once every three weeks for 40 weeks
    Other Name: Herceptin
Detailed Description:
  • Participants will enroll in this study at the time they are starting their adjuvant therapy for breast cancer. Participants will receive chemotherapy with paclitaxel every week for 12 weeks. They will begin to receive trastuzumab at the same time they begin paclitaxel. Once they have completed the 12 weeks of paclitaxel and trastuzumab, they will receive trastuzumab every 3 weeks or weekly for 40 weeks.
  • Participants will be followed with routine assessments such as physical exam and vital signs every 3 months for the first year, and then every 6 months for years 2-5. Then we would like to keep track of the participants medical condition by calling them on the telephone once per year.
  Eligibility

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

Inclusion Criteria:

  • Histologically confirmed invasive carcinoma of the breast
  • Tumors must be less than or equal to 3cm in greatest dimension
  • Must have node-negative breast cancer according to teh AJCC 7th edition
  • ER/PR determination is required. ER- and PR-assays should be performed by immunohistochemical methods
  • HER-2 positive: IHC 3+ or FISH >2
  • Bilateral breast cancers that individually meet eligibility criteria are allowed
  • Patients should have tumor tissue available, and a tissue block of sufficient size to make 15 slides must be sent to DFCI for testing
  • Less than or equal to 84 days from mastectomy or from axillary dissection or sentinel node biopsy if the patient's most extensive breast surgery was a breast-sparing procedure
  • All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy (lumpectomy), with either a sentinel node biopsy or axillary dissection
  • 18 years of age or older
  • ECOG Performance Status of 0 or 1
  • Adequate bone marrow function, hepatic function, and renal function as outlined in protocol
  • Left ventricular ejection fraction of greater than or equal to 50%
  • Willingness to discontinue any hormonal agent prior to registration and while on study
  • Willingness to discontinue sex hormonal therapy, e.g. birth control pills, prior to registration and while on study
  • Patients with a history of ipsilateral DCIS are eligible if they were treated with wide-excision alone, without radiation therapy
  • Patients undergoing breast conservation therapy must not have any contraindications to radiation therapy

Exclusion Criteria:

  • Pregnant or nursing women
  • Locally advanced tumors at diagnosis, including tumors fixed to the chest wall, peau d'orange, skin ulcerations/nodules, or clinical inflammatory changes
  • History of prior chemotherapy in past 5 years
  • History of prior trastuzumab therapy
  • Active, unresolved infection
  • Prior history of any other malignancy in the past 5 years, except for early stage tumors of the skin or cervix treated with curative intent
  • Sensitivity to benzyl alcohol
  • Grade 2 or greater neuropathy per NCI's CTCAv3.0. (Exception: Any chronic neurologic disorder will be looked at on a case-by-case basis by the study chair).
  • Active cardiac disease as outlined in protocol.
  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: NCT00542451

Locations
United States, California
University of California-San Francisco
San Francisco, California, United States, 94115
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Maryland
John Hopkins University
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Dana-Farber at Faulkner Hospital
Boston, Massachusetts, United States, 02130
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Cape Cod Healthcare
Hyannis, Massachusetts, United States, 02601
Lowelll General Hospital
Lowell, Massachusetts, United States, 01854
North Shore Medical Center
Peabody, Massachusetts, United States, 01960
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, New York
North Shore LIJ Health System Monter Cancer Center
Lake Success, New York, United States, 11042
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Weill Cornell Medical College
New York, New York, United States, 10065
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Ohio
Case Western University
Cleveland, Ohio, United States, 44195
United States, Tennessee
Tennesse Oncology
Nashville, Tennessee, United States, 37203
United States, Vermont
University of Vermont Cancer Center
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
Eric Winer, MD
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Genentech, Inc.
Investigators
Principal Investigator: Eric Winer, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Eric Winer, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00542451     History of Changes
Other Study ID Numbers: 07-199
Study First Received: October 9, 2007
Last Updated: March 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
node-negative breast cancer
HER-2 positive

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

ClinicalTrials.gov processed this record on October 20, 2014