We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00542451
Recruitment Status : Completed
First Posted : October 11, 2007
Last Update Posted : September 6, 2022
Sponsor:
Collaborators:
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Genentech, Inc.
Information provided by (Responsible Party):
Sara Tolaney, Dana-Farber Cancer Institute

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Carcinoma of the Breast Drug: Paclitaxel Drug: Trastuzumab Phase 2

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer
Study Start Date : October 2007
Actual Primary Completion Date : April 21, 2014
Actual Study Completion Date : August 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Describe DFS in patient groups defined by tumor size and hormone receptor status. [ Time Frame: 3 years ]
  2. Evaluate the incidence of grade III/IV cardiac left ventricular dysfunction from adjuvant trastuzumab and paclitaxel [ Time Frame: 3 years ]
  3. Evaluate the incidence of grade III/IV neurotoxicity associated with adjuvant paclitaxel [ Time Frame: 3 years ]
  4. Evaluate Topoisomerase II, cMYC, and p53 expression, and correlate with event rate [ Time Frame: 3 years ]
  5. 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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00542451


Locations
Show Show 20 study locations
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Genentech, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Sara Tolaney, MD, MPH Dana-Farber Cancer Institute
  Study Documents (Full-Text)

Documents provided by Sara Tolaney, Dana-Farber Cancer Institute:
Study Protocol and Statistical Analysis Plan  [PDF] November 18, 2021

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Sara Tolaney, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00542451    
Other Study ID Numbers: 07-199
First Posted: October 11, 2007    Key Record Dates
Last Update Posted: September 6, 2022
Last Verified: August 2022
Keywords provided by Sara Tolaney, Dana-Farber Cancer Institute:
node-negative breast cancer
HER-2 positive
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Trastuzumab
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological