Neoadjuvant TDM1 With Lapatinib and Abraxane Compared With Trastuzumab With Lapatinib and Paclitaxel
Overview[ - collapse ][ - ]
Purpose | Purpose: The purpose of this study is to evaluate the Pathological Complete Response (pCR) of the breast when trastuzumab emtansine (TDM-1) plus Lapatinib plus Abraxane is combined in newly diagnosed HER2 positive breast cancer. This is a randomized, open label Phase II neo-adjuvant study comparing the efficacy of neoadjuvant Trastuzumab Emtansine (TDM1) plus lapatinib follow by Abraxane, versus trastuzumab (herceptin) plus Lapatinib follow by paclitaxel. |
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Condition | Breast Cancer |
Intervention | Drug: Trastuzumab Emtansine Drug: Trastuzumab Drug: Lapatinib Drug: Abraxane Drug: Paclitaxel |
Phase | Phase 2 |
Sponsor | The Methodist Hospital System |
Responsible Party | The Methodist Hospital System |
ClinicalTrials.gov Identifier | NCT02073487 |
First Received | February 18, 2014 |
Last Updated | February 25, 2014 |
Last verified | February 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | February 18, 2014 |
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Last Updated Date | February 25, 2014 |
Start Date | February 2014 |
Estimated Primary Completion Date | June 2016 |
Current Primary Outcome Measures | pathological complete response rate (pCR) [Time Frame: From date of randomization until the date of surgery, approximately 16 weeks] [Designated as safety issue: Yes]To evaluate the pathological complete response rate (pCR) in the breast after treatment with Trastuzumab Emtansine plus Lapatinib follow by Abraxane in women with HER2 Neu over-expressed breast cancer patients. |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Neoadjuvant TDM1 With Lapatinib and Abraxane Compared With Trastuzumab With Lapatinib and Paclitaxel |
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Official Title | Randomized Open Label Phase II Trial Of Neoadjuvant Trastuzumab Emtansine (Te) In Combination With Lapatinib (L) Follow by Abraxane (A) Compared With Trastuzumab Plus Lapatinib Follow by Paclitaxel In Her 2 Neu Over-Expressed Breast Cancer Patients (TEAL Trial) |
Brief Summary | Purpose: The purpose of this study is to evaluate the Pathological Complete Response (pCR) of the breast when trastuzumab emtansine (TDM-1) plus Lapatinib plus Abraxane is combined in newly diagnosed HER2 positive breast cancer. This is a randomized, open label Phase II neo-adjuvant study comparing the efficacy of neoadjuvant Trastuzumab Emtansine (TDM1) plus lapatinib follow by Abraxane, versus trastuzumab (herceptin) plus Lapatinib follow by paclitaxel. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Breast Cancer |
Intervention | Drug: Trastuzumab Emtansine trastuzumab emtansine [Kadcyla] Intravenous repeating dose every 3 weeks Other Names:
Trastuzumab (Herceptin) Intravenous repeating dose weekly Other Names: HerceptinDrug: Lapatinib Lapatinib repeating dose taken orally every day for 6 weeks Other Names: tykerbDrug: Abraxane Abraxane repeating dose weekly IV for up to 12 weeks Drug: Paclitaxel Paclitaxel IV repeating dose weekly for up to 12 weeks |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 30 |
Estimated Completion Date | June 2016 |
Estimated Primary Completion Date | June 2015 |
Eligibility Criteria | Inclusion Criteria: - Female gender; - Age ≥18 years; - Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1 - Histologically confirmed invasive breast cancer: - Primary tumor greater than 1 cm diameter, measured by clinical examination and mammography or ultrasound. - Any N, - No evidence of metastasis (M0) (isolated supra-clavicular node involvement allowed); - Over expression and/or amplification of HER2 in the invasive component of the primary tumor and confirmed by a certified laboratory prior to randomization. - Known hormone receptor status. - Hematopoietic status: - CBC not less than .75 of institutional lower limit. Absolute neutrophil count ≥ 1,5 x 10^9/L, Platelet count ≥ 100 x 10^9/L, Hemoglobin at least 9 g/dl, - Hepatic status: Serum total bilirubin ≤ 2 x upper limit of normal (ULN). In the case of known Gilbert's syndrome, a higher serum total bilirubin (< 1.5 x ULN) is allowed, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3.5 times ULN, Alkaline phosphatase ≤ 2.5 times ULN, • Renal status: Creatinine ≤ 1.5mg/dL, • Cardiovascular: Baseline left ventricular ejection fraction (LVEF) ³ ≥50% measured by echocardiography (ECHO) or Multiple Gate Acquisition (MUGA) scan, - Negative serum or urine β-hCG pregnancy test at screening for patients of childbearing potential within 2-weeks (preferably 7 days) prior to randomization. - Fertile patients must use effective contraception (barrier method - condoms, diaphragm - also in conjunction with spermicidal jelly, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not allowed) - Signed informed consent form (ICF) - Patient accepts to make available tumor samples for submission to central laboratory to conduct translational studies as part of this protocol. Exclusion Criteria: - Previous (less than 5 years) or current history of malignant neoplasms, except for curatively treated: Basal and squamous cell carcinoma of the skin; Carcinoma in situ of the cervix. - Patients with a prior malignancy diagnosed more than 5 years prior to randomization may enter the study. - Preexisting peripheral neuropathy ≥ grade 2 - Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension (≥180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen; - Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety; - Unresolved or unstable, serious adverse events from prior administration of another investigational drug; - Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF; - Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded; - Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies); - Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial; - Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trastuzumab Emtansine, trastuzumab, lapatinib, paclitaxel, abraxane or their components; - Pregnant or lactating women; - Concomitant use of CYP3A4 inhibitors or inducers - Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol - Patients have an active infection and require IV or oral antibiotics. - Pregnant or breast-feeding women - Patients unwilling or unable to comply with the protocol |
Gender | Female |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Houston Methodist Cancer Center 713-441-0629 ccresearch@houstonmethodist.org |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT02073487 |
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Other Study ID Numbers | 1013-0164 |
Has Data Monitoring Committee | No |
Information Provided By | The Methodist Hospital System |
Study Sponsor | The Methodist Hospital System |
Collaborators | Celgene Corporation GlaxoSmithKline |
Investigators | Principal Investigator: Jenny CN Chang, MD Houston Methodist Hospital |
Verification Date | February 2014 |
Locations[ + expand ][ + ]
Houston Methodist Hospital | Houston, Texas, United States, 77030 Contact: Houston Methodist Cancer Center | 713-441-0629 | ccresearch@houstonmethodist.orgSub-Investigator: Angel A Rodriguez, MD Recruiting |
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