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Neoadjuvant TDM1 With Lapatinib and Abraxane Compared With Trastuzumab With Lapatinib and Paclitaxel

Information source: The Methodist Hospital System
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: Trastuzumab Emtansine (Drug); Trastuzumab (Drug); Lapatinib (Drug); Abraxane (Drug); Paclitaxel (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: The Methodist Hospital System

Official(s) and/or principal investigator(s):
Jenny CN Chang, MD, Principal Investigator, Affiliation: The Methodist Hospital System

Overall contact:
Houston Methodist Cancer Center, Phone: 713-441-0629, Email: ccresearch@houstonmethodist.org

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.

Clinical Details

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)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: pathological complete response rate (pCR)

Secondary outcome:

Clinical Response Rate

breast imaging response to treatment

objective response rate

toxicity, safety and efficacy of study treatment

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

Houston Methodist Cancer Center, Phone: 713-441-0629, Email: ccresearch@houstonmethodist.org

Houston Methodist Hospital, Houston, Texas 77030, United States; Recruiting
Houston Methodist Cancer Center, Phone: 713-441-0629, Email: ccresearch@houstonmethodist.org
Angel A Rodriguez, MD, Sub-Investigator
Daniel Lehane, MD, Sub-Investigator
Tejal Patel, MD, Sub-Investigator
Monisha Singh, MD, Sub-Investigator
Jorge Darcourt, MD, Sub-Investigator
Additional Information

Starting date: February 2014
Last updated: February 25, 2014

Page last updated: August 23, 2015

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