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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

October 9, 2007
March 17, 2014
October 2007
April 2014   (final data collection date for primary outcome measure)
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 ]
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
Complete list of historical versions of study NCT00542451 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Describe DFS in patient groups defined by tumor size and hormone receptor status.
  • Evaluate the incidence of grade III/IV cardiac left ventricular dysfunction from adjuvant trastuzumab and paclitaxel
  • Evaluate the incidence of grade III/IV neurotoxicity associated with adjuvant paclitaxel
  • Evaluate Topoisomerase II, cMYC, and p53 expression, and correlate with event rate
  • Evaluate P13K mutations and PTEN alterations in a subset of patients and correlate events with the presence or absence of these mutations/alterations
Not Provided
Not Provided
 
Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer
A Phase II Trial of Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer

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.

  • 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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer
  • Carcinoma of the Breast
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
420
December 2021
April 2014   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00542451
07-199
Yes
Eric Winer, MD, Dana-Farber Cancer Institute
Eric Winer, MD
  • Brigham and Women's Hospital
  • Beth Israel Deaconess Medical Center
  • Massachusetts General Hospital
  • Genentech, Inc.
Principal Investigator: Eric Winer, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP