Breast Cancer Clinical Trial
Official title:
A Phase II Trial of Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer
NCT number | NCT00542451 |
Other study ID # | 07-199 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | October 2007 |
Est. completion date | August 30, 2022 |
Verified date | November 2023 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 406 |
Est. completion date | August 30, 2022 |
Est. primary completion date | April 21, 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | John Hopkins University | Baltimore | Maryland |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Dana-Farber at Faulkner Hospital | Boston | Massachusetts |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | University of Vermont Cancer Center | Burlington | Vermont |
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
United States | Case Western University | Cleveland | Ohio |
United States | Duke Comprehensive Cancer Center | Durham | North Carolina |
United States | Cape Cod Healthcare | Hyannis | Massachusetts |
United States | Indiana University | Indianapolis | Indiana |
United States | North Shore LIJ Health System Monter Cancer Center | Lake Success | New York |
United States | Lowell General Hospital | Lowell | Massachusetts |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | Tennessee Oncology | Nashville | Tennessee |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | Weill Cornell Medical College | New York | New York |
United States | North Shore Medical Center | Peabody | Massachusetts |
United States | Washington University | Saint Louis | Missouri |
United States | University of California-San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Genentech, Inc., Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 3-year Disease Free Survival (DFS) Rate | Disease-free survival (DFS) is the proportion of participants ramaing disease free at 3 years based on the Kaplan-Meier method. DFS is defined to end at the time of the first of the following events: local/regional ipsilateral invasive recurrence (or ipsilateral invasive new primary), contralateral invasive breast cancer, distant recurrence, or death from any cause. | at 3 years | |
Secondary | Disease Free Survival (DFS) in Patients With Tumors Measuring =1 cm or > 1 cm | DFS is defined as the time from registration to the first of the following events: local/regional ipsilateral invasive recurrence (or ipsilateral invasive new primary), contralateral invasive breast cancer, distant recurrence, or death from any cause. Patients without an event are censored at the date of last evaluation. | at 3 years | |
Secondary | Number of Patients With Grade III/IV Cardiac Left Ventricular Dysfunction | cardiac left ventricular dysfunction related adverse events (AE) with any attribution of possibly, probably or definite based on CTCAEv3 as reported on case report forms were counted. | AE evaluated on treatment every week during paclitaxel and every 9 weeks during trastuzumab monotheryapy, and at progression, and observation years 2-10. Median treatment duration was 11.4 months (range 0 - 23.5 months). | |
Secondary | Number of Patients With Grade III/IV Neurotoxicity | Nervous system disorders related adverse events (AE) with any attribution of possibly, probably or definite based on CTCAEv3 as reported on case report forms were counted. | AE evaluated on treatment every week during paclitaxel and every 9 weeks during trastuzumab monotheryapy, and at progression, and observation years 2-10. Median treatment duration was 11.4 months (range 0 - 23.5 months). | |
Secondary | Number of Patients With Amenorrhea | Patients that eligible for amenorrhea assessment and data collecting will be evaluated by standard method defined per protocol 3.9, through menses assessment survey. | Menses Assessment survey on Q6 months x 1 year, then q6months for year 2 and at progression, and observation years 2-10 or until progression. |
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