Phase 2
Completed N=18
Lapatinib Ditosylate, Trastuzumab, Paclitaxel, and Surgery in Treating Patients With Breast Cancer
HER2-positive breast cancer · Stage II Breast Cancer · Stage IIIA Breast Cancer
Source: ClinicalTrials.gov NCT01688609 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcomePrimary: Expression of ALDH1 and CD44v Change in the Binary Biomarkers From Baseline to 6 Weeks and 18 Weeks — 5; 3; 0; 4 Participants
Summary
This phase II trial studies how well giving lapatinib ditosylate together with trastuzumab, paclitaxel, and surgery works in treating patients with breast cancer. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Expression of ALDH1 and CD44v Change in the Binary Biomarkers From Baseline to 6 Weeks and 18 Weeks |
5; 3; 0; 4; 0; 5 | — |
| PRIMARY Number of Participants With Pathological Complete Response (pCR) |
8 | — |
| SECONDARY Cellular Response Rate, Defined as Patients With an Epithelial Phenotype Having Eradication of CTCs; Patients With a Mesenchymal Phenotype Having Eradication of Tumor Cells; Patients With a Mesenchymal Phenotype Converting to an Epithelial Phenotype |
4; 10 | — |
| SECONDARY EGFR-mutation Status of Tumors and Changes in the Ratio of Phosphorylated to Nonphosphorylated HER2, EGFR, ERK, Akt, and the Ki67 and TUNEL Indices Before and After Treatment |
— | — |
| SECONDARY Number of Participants With Treatment-Related Toxicities |
2; 1; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have histologically or cytologically confirmed primary invasive breast cancer
- Primary tumor is larger than 2 cm in diameter (T2) as measured by caliper or ultrasound
- Overexpression and/or amplification of HER2 is confirmed by immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) + when IHC 2+
- Patients have not received prior therapies for breast cancer
- Patients have Karnofsky >= 70%
- Leukocytes >= 3,000/mcL
- Absolute neutrophil count >= 1,500/mcL
- Hemoglobin >= 9.0 g/dL
- Platelets >= 75,000/mcL
- Total bilirubin = = 50% by multi-gated acquisition (MUGA) or echocardiography
- Patients must be able to take oral medications (i.e., no uncontrolled vomiting, inability to swallow, or diagnosis of chronic malabsorption)
- Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation as well as for at least 6 months after the last dose of trastuzumab
- Ability to understand and willingness not only for treatment but also for undergoing serial biopsies and sign a written informed consent document
- Only Japanese women are eligible for the trial
Exclusion Criteria
- Patients who have had chemotherapy or radiotherapy
- Patients who are receiving any other investigational agents
- Patients have distal metastasis (stage IV disease)
- Patients with previous (within 10 years) or current history of malignant neoplasm except for curatively treated basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib or other agents used in study
- Patients receiving any medications or substances that are inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) are ineligible
- Patients who have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women
- Patients who have family or personal history of congenital long or short QT syndrome, Brugada syndrome, QT/QTc prolongation, or torsade de pointes
- Patients who have chronic gastrointestinal disease presenting with diarrhea (inflammatory bowel disease, malabsorption, or >= grade 2 diarrhea of any etiology at baseline)
- Patients who have neuropathy >= grade 2 of any cause
- Patients are diagnosed with inflammatory breast cancer or bilateral breast cancer
Data sourced from ClinicalTrials.gov (NCT01688609). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.