Breast Cancer
Conditions
Keywords
recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, male breast cancer
Brief summary
The purpose of this study is to study a new treatment for HER-2/neu (+) breast cancer.
Interventions
BIOLOGICALtrastuzumab
DRUGcyclophosphamide
DRUGdoxorubicin hydrochloride
DRUGlapatinib ditosylate
DRUGpaclitaxel
OTHERlaboratory biomarker analysis
Sponsors
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
GlaxoSmithKline
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the breast * Bilateral synchronous breast tumors allowed * Any nodal status or tumor size allowed * No stage IV disease * HER2/neu-positive disease * 3+ by IHC OR FISH-amplified * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Male or female * Menopausal status not specified * ECOG performance status 0-1 * Absolute neutrophil count ≥ 1,000/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ 1.1 mg/dL * SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and after completion of study therapy * LVEF ≥ 50% by MUGA scan * No peripheral neuropathy \> grade 1 * No active second malignancy within the past 5 years except for adequately treated nonmelanoma skin cancer or in situ carcinoma of the cervix * No known allergy or hypersensitivity to doxorubicin hydrochloride, cyclophosphamide, paclitaxel, or other drugs formulated in Cremophor EL * No psychiatric illness or concurrent medical conditions that would preclude study treatment * No other conditions, including any of the following: * Unstable angina * Congestive heart failure * Myocardial infarction within the past 12 months * High-risk uncontrolled arrhythmias (e.g., ventricular tachycardia, high-grade AV block, or supraventricular arrhythmias that are not adequately controlled) * No QT prolongation (\> 500 ms) * No active unresolved infections * No sensitivity to E. coli derived proteins PRIOR CONCURRENT THERAPY: * Prior hormonal therapy for chemoprevention allowed * No prior trastuzumab (Herceptin®) * No prior anthracyclines * No concurrent hormonal therapy, including hormonal contraception (e.g., birth control pills or ovarian hormonal or replacement therapy) * No other concurrent chemotherapy, radiotherapy, immunotherapy, or biotherapy for breast cancer * No concurrent drugs that may prolong the QT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Completed All Planned Therapy | 2 years | The number of patients who completed all planned therapy (dose-dense adjuvant/ neoadjuvant chemotherapy regimen) in HER-2/neu-overexpressed/ amplified breast cancer patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Were Evaluated for Toxicity | 2 years | Please see adverse event section in the results. Toxicities were assessed by the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 3.0. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate. | 95 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 93 Participants |
| Region of Enrollment United States | 95 participants |
| Sex: Female, Male Female | 94 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 94 / 95 |
| serious Total, serious adverse events | 23 / 95 |
Outcome results
Primary
Number of Patients Who Completed All Planned Therapy
The number of patients who completed all planned therapy (dose-dense adjuvant/ neoadjuvant chemotherapy regimen) in HER-2/neu-overexpressed/ amplified breast cancer patients.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB | Number of Patients Who Completed All Planned Therapy | 45 participants |
Secondary
Number of Patients Who Were Evaluated for Toxicity
Please see adverse event section in the results. Toxicities were assessed by the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 3.0.
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB | Number of Patients Who Were Evaluated for Toxicity | 95 Participants |