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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Translational Oncology Research International
• Collaborators: National Cancer Institute (NCI); University of California, Los Angeles
• Treatments: Carboplatin; Docetaxel; Lapatinib; Trastuzumab

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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