Docetaxel, Carboplatin, and Trastuzumab and/or Lapatinib in Treating Women With Stage I, Stage II, or Stage III Breast Cancer That Can Be Removed by Surgery

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether docetaxel and carboplatin are more effective when given together with trastuzumab and/or lapatinib in treating women with stage I, stage II, or stage III breast cancer. PURPOSE: This randomized phase II trial is studying how well docetaxel and carboplatin work when given together with trastuzumab and/or lapatinib in treating women with stage I, stage II, or stage III breast cancer that can be removed by surgery.

Key facts

Study ID: NCT00769470
Run by: Translational Oncology Research International
People needed: 18
Starts: 2009-04-01
Last updated by the study team: 2016-01-22

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Women aged 18 to 70 years, inclusive
Histologically or cytologically confirmed adenocarcinoma of the breast
Stage I, II or III disease (early stage) with tumor measuring ≥ 1 cm and meeting any the following criteria:
Grade > 1
Estrogen receptor- and progesterone receptor-negative
Age ≤ 35 years
HER2/neu-positivity by fluorescence in situ hybridization (FISH)
Estrogen and progesterone receptor status known prior to study entry.
ECOG performance status 0-1 Adequate organ function (ejection fraction>- lower limit of normal) as determined by MUGA or echocardiogram.
If female of childbearing potential, pregnancy test is negative and is willing to use effective contraception while on treatment and for at least 3 months after the last dose of study therapy.
patient is accessible and willing to comply with treatment, tissue acquisition and follow up.
patient is willing to provide written informed consent prior to performance of any study-related procedure.
Adequate organ function as defined by the following laboratory values
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 9.0 g/dL
Creatinine < 1.5 mg/dL
Total bilirubin ≤ 1.0 times upper limit of normal (ULN) (< 3 times ULN in patients with Gilbert's syndrome confirmed by genotyping or Invader UGTIA1 molecular assay)
Alkaline phosphatase (AP), ALT, and AST must meet 1 of the following criteria:
AP normal AND AST/ALT ≤ 2.5 times upper limit of normal (ULN)
AP ≤ 2.5 times ULN AND ALT/AST ≤ 1.5 times ULN
AP ≤ 5 times ULN AND AST/ALT normal

You may not qualify if…

Inflammatory breast cancer, defined as the presence of erythema or induration involving > 1/3 of the breast
Bilateral invasive breast cancer
Metastatic disease
Concurrent therapy with any other non-protocol anti-cancer therapy
history of any other malignancy within the past 5 years, with the exception of nonmelanoma skin cancer or carcinoma in situ of the cervix
pre-existing motor or sensory neurotoxicity ≥ grade 2 by NCI NTCAE version 3.0
cardiac disease including any of the following:
Myocardial infarction within the past 6 months
Unstable angina
New York Heart Association class II-IV congestive heart failure
inflammatory bowel disease or other bowel condition causing chronic diarrhea and requiring active therapy
active, uncontrolled infection requiring parenteral antimicrobials
known hypersensitivity to Chinese hamster ovary products or other recombinant human or humanized antibodies and/or known hypersensitivity to any of the study drugs or their ingredients (e.g., polysorbate 80 in docetaxel)
other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of study drugs or place the subject at undue risk for treatment complications
hormonal agent (e.g., raloxifene, tamoxifen citrate, or other selective estrogen receptor modulators) for osteoporosis or prevention of breast cancer. subjects must have discontinued these agents 14 days prior to first baseline biopsy.
prior ipsilateral radiotherapy for invasive or noninvasive breast cancer or to the ipsilateral chest wall for any malignancy
prior chemotherapy, radiotherapy, or endocrine therapy for currently diagnosed invasive or noninvasive breast cancer
concurrent ovarian hormonal replacement therapy. Prior treatment must be stopped prior to first baseline biopsy.
male subjects
pregnant or lactating subjects

Where it is running

Central Hematology Oncology Medical Group, Incorporated - Alhambra — Alhambra, California, United States
Comprehensive Blood and Cancer Center — Bakersfield, California, United States
St. Jude Heritage Medical Group at Virginia K. Crosson Cancer Center — Fullerton, California, United States
North Valley Hematology-Oncology Medical Group — Northridge, California, United States
Wilshire Oncology Medical Group, Incorporated - Pomona — Pomona, California, United States
Sansum Medical Clinic — Santa Barbara, California, United States
Central Coast Medical Oncology Corporation — Santa Maria, California, United States
Santa Barbara Hematology Oncology - Solvang — Solvang, California, United States
Cancer Care Associates Medical Group, Incorporated - Redondo Beach — Torrance, California, United States
Cancer Institute of Florida, PA - Orlando — Orlando, Florida, United States
Florida Hospital Cancer Institute — Orlando, Florida, United States
Hematology and Oncology Consultants, PA - Orlando — Orlando, Florida, United States
Providence Medical Group — Haute Terre, Indiana, United States
Comprehensive Cancer Centers of Nevada - Henderson — Henderson, Nevada, United States
New Mexico Cancer Center — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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