A Study of AC Followed by a Combination of Paclitaxel Plus Trastuzumab or Lapatinib or Both Given Before Surgery to Patients With Operable HER2 Positive Invasive Breast Cancer

Status unconfirmed · Phase 3

Conditions studied: Invasive Breast Cancer

In brief

The primary purpose of this study is to determine whether breast cancer tumors respond (as measured by pathologic complete response: the absence of microscopic evidence of invasive tumor cells in the breast) to combined chemotherapy of AC(doxorubicin and cyclophosphamide) followed by paclitaxel plus trastuzumab or lapatinib or both given before surgery to patients with HER2-positive breast cancer. Trastuzumab will also be given to all patients after surgery. The study will also evaluate the toxic effects of the chemotherapy combination, including effects on the heart, and will determine survival and progression-free survival 5 years after treatment. Also, the study will look at whether there are gene expression profiles in the tumor tissue that can predict pathologic complete response.

Key facts

Study ID

NCT00486668

Run by

NSABP Foundation Inc

People needed

529

Starts

2007-07-01

Expected to finish

2017-03-01

Last updated by the study team

2016-06-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female
• 18 years or older
• ECOG performance status of 0 or 1
• Primary breast tumor palpable and measures greater than or equal to 2.0 cm by physical exam
• Diagnosis of invasive adenocarcinoma made by core needle biopsy
• Breast cancer determined to be HER2-positive
• LVEF assessment by MUGA scan or ECG within 3 months prior to randomization
• Blood counts must meet the following criteria:
• ANC greater than or equal to 1200/mm3
• Platelet count greater than or equal to 100,000/mm3
• Hemoglobin greater than or equal to 10 g/dL
• Serum creatinine less than or equal to ULN for the lab
• Adequate hepatic function by these criteria:
• Total bilirubin less than or equal to the ULN for the lab unless the patient has a bilirubin elevation greater than ULN to 1.5 x ULN resulting from Gilbert's disease or similar syndrome due to slow conjugation of bilirubin; and
• Alkaline phosphatase less than or equal to 2.5 x ULN; and
• AST less than or equal to 1.5 x ULN for the lab.
• If skeletal pain present or alkaline phosphatase greater than ULN (but less than or equal to 2.5 x ULN), bone scan or PET scan must not demonstrate metastatic disease
• If AST or alkaline phosphatase greater than ULN , liver imaging (CT, MRI or PET scan) must not demonstrate definitive metastatic disease and the requirements in criterion for hepatic function must be met
• Able to swallow oral medications

You may not qualify if…

• FNA alone to diagnose the primary tumor
• Excisional biopsy or lumpectomy was performed prior to randomization
• Surgical axillary staging procedure prior to randomization. Exceptions: 1) FNA or core biopsy of an axillary node for any patient, and 2) although not recommended, a pre-neoadjuvant therapy SN biopsy for patients with clinically negative axillary nodes.
• Tumors clinically staged as T4
• Ipsilateral cN2b or cN3 disease (Patients with cN1 or cN2a disease are eligible)
• Definitive clinical or radiologic evidence of metastatic disease
• Synchronous bilateral invasive breast cancer
• Requirement for chronic use of any of the medications or substances specified in the protocol
• Treatment including RT, chemotherapy, and/or targeted therapy for the currently diagnosed breast cancer prior to randomization
• Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, etc. (These patients are eligible if therapy is discontinued prior to randomization)
• Continued therapy with any hormonal agent such as raloxifene, tamoxifen, or other SERM. (Patients are eligible only if these medications are discontinued prior to randomization)
• Prior history of breast cancer, including DCIS (Patients with a history of LCIS are eligible)
• Prior therapy with anthracyclines, taxanes, trastuzumab, or lapatinib for any malignancy
• Other malignancies unless the patient is considered to be disease-free for 5 or more years prior to randomization and is deemed by her physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
• Cardiac disease that would preclude the use of the drugs included in the B-41 treatment regimens. This includes but is not confined to:
• Active cardiac disease:
• angina pectoris requiring the use of anti-anginal medication;
• ventricular arrhythmias except for benign premature ventricular contractions controlled by medication;
• conduction abnormality requiring a pacemaker;
• supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; and
• clinically significant valvular disease.
• History of cardiac disease:
• myocardial infarction;
• congestive heart failure; or
• cardiomyopathy.

Where it is running

• Scripps Cancer Center-San Diego — La Jolla, California, United States
• University of California, Irvine Medical Center — Long Beach, California, United States
• Pacific Shores Medical Group — Long Beach, California, United States
• St. Joseph Hospital — Orange, California, United States
• Desert Regional Medical Center Comprehensive Cancer Center — Palm Springs, California, United States
• Stanford University Medical Center — Palo Alto, California, United States
• Sutter Medical Center — Sacramento, California, United States
• Kaiser Permanente-San Diego — San Diego, California, United States
• Santa Rosa Memorial Hospital — Santa Rosa, California, United States
• Kaiser Permanente-Vallejo — Vallejo, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• Memorial Hospital — Colorado Springs, Colorado, United States
• Kaiser Permanente-Franklin — Denver, Colorado, United States
• CCOP-Colorado Cancer Research Prog. Inc.(Administrative Only) — Denver, Colorado, United States
• Kaiser Permanente Rock Creek — Lafayette, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Eastern Connecticut Hematology & Oncology Associates — Norwich, Connecticut, United States
• Sibley Memorial Hospital — Washington D.C., District of Columbia, United States
• MD Anderson Cancer Center — Orlando, Florida, United States
• Phoebe Putney Memorial Hospital — Albany, Georgia, United States
• MBCCOP, Medical College of Georgia Research Institute — Augusta, Georgia, United States
• University of Hawaii — Honolulu, Hawaii, United States
• Kaiser Permanente Hawaii - Moanalua Med Center — Honolulu, Hawaii, United States
• Kootenai Cancer Center — Coeur d'Alene, Idaho, United States
• MBCCOP, Gulf Coast — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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