Breast Cancer
Conditions
Keywords
HER-2 Positive Breast Cancer, herceptin, navelbine, taxotere, carboplatin, Early stage Breast Cancer
Brief summary
The purpose of this study is to find out what effects the preoperative combination therapies of herceptin/navelbine or herceptin/taxotere/carboplatin will have on patients with early stage HER-2 positive breast cancer.
Detailed description
Before starting treatment, a clip will be placed via catheter into the tumor bed, so the surgeon can locate the site of the tumor. During clip placement, tissue biopsy will be taken of the tumor. One to two weeks after the first dose of herceptin another biopsy will be performed. Patients will be placed into one of 2 arms. * Arm 1 receives 12 weeks of herceptin and navelbine. Arm 2 receives 4 cycles of taxotere/carboplatin/herceptin. * Arm 2 participants will also receive neulasta (growth factor support) on day 2 of each cycle. Phase A of Arm 1 is one dose of herceptin followed by an MRI of the affected breast and a second biopsy 1-2 weeks following this dose. Phase B of Arm 1 begins on week 3 and ends on week 14 and involves weekly injections of herceptin and navelbine. Surgery will take place a minimum of 3 weeks after the patients last dose of herceptin and navelbine. Phase A of Arm 2 is one dose of herceptin followed by an MRI of the affected breast and second biopsy 1-2 weeks following this dose. Phase B of Arm 2 begins on week 3 and ends on week 14 and involves herceptin weekly, taxotere and carboplatin every 3 weeks. Surgery will take place a minimum of 3 weeks after the patients last dose of herceptin, taxotere and carboplatin. Blood tests will be performed every 3 weeks during pre-operative treatment and every 6 months after surgery.
Interventions
DRUGHerceptin
One dose given followed by an MRI, then weekly injections beginning week 3 and ending week 14.
DRUGNavelbine
Weekly injections given starting week 3 and ending week 14
DRUGTaxotere
Given every three weeks starting week 3 and ending on week 14
DRUGCarboplatin
Given every three weeks starting week 3 and ending on week 14
Sponsors
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Yale University
Eric Winer, MD
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with stage II or III breast cancer * HER-2 positive tumors * Older than 18 years of age * Eastern Cooperative Oncology Group (ECOG) Performance Status of greater or equal to 1. * ANC \> 1,500/mm3 * Hemoglobin \> 9gm/dl * Platelets \> 100,000mm3 * Creatinine \< 2mg/dl * Glucose \< 200mg/dl * Bilirubin \< 1.5 x ULN
Exclusion criteria
* Previous treatment with herceptin, taxanes, doxorubicin or other anthracycline-type therapy, navelbine, or platinum-based therapy. * Pregnant or breast-feeding women * Serious illness, or medical or psychiatric condition * Uncontrolled infections * Active or severe cardiovascular or pulmonary disease * Patients with left ventricular ejection fraction \< 50% * Peripheral neuropathy of any etiology that exceeds grade 1 * Prior history of malignancy * Uncontrolled diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer | 12 weeks | Pathological Complete Response is defined as the complete disappearance of invasive tumor in the breast at the time of surgery |
Countries
United States
Participant flow
Recruitment details
A total of 81 patients were enrolled on the study between 12/2003 and 8/2008.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 Herceptin/navelbine | 41 |
| Arm 2 Taxotere/carboplatin/herceptin | 40 |
| Total | 81 |
Baseline characteristics
| Characteristic | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Age Continuous | 47.8 years STANDARD_DEVIATION 12.6 | 48.1 years STANDARD_DEVIATION 8.5 | 48 years STANDARD_DEVIATION 10.7 |
| Region of Enrollment United States | 41 participants | 40 participants | 81 participants |
| Sex: Female, Male Female | 41 Participants | 40 Participants | 81 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 27 / 41 | 25 / 40 |
| serious Total, serious adverse events | 5 / 41 | 5 / 40 |
Outcome results
Primary
Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer
Pathological Complete Response is defined as the complete disappearance of invasive tumor in the breast at the time of surgery
Time frame: 12 weeks
Population: Please Note that in Arm 2, the number of participants analyzed is equal to 39, which differs from the Number of Participants reported in the baseline measure (N= 40) because one participant withdrew her consent, so was not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 | Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer | 17 percentage of participants |
| Arm 2 | Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer | 31 percentage of participants |