Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Eric Winer, MD
Collaborators:
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Genentech
Information provided by (Responsible Party):
Eric Winer, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00542451
First received: October 9, 2007
Last updated: January 8, 2013
Last verified: January 2013
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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 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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
- 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
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 Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Dana-Farber at Faulkner Hospital | |
| Boston, Massachusetts, United States, 02130 | |
| 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 | |
| Weill Cornell Medical College | |
| New York, New York, United States, 10065 | |
| Memorial Sloan Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| 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
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: | January 8, 2013 |
| 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 Carcinoma Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Paclitaxel |
Trastuzumab Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013