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Neoadjuvant TDM1 With Lapatinib and Abraxane Compared With Trastuzumab Plus Pertuzumab With Paclitaxel (TEAL)

This study is currently recruiting participants.
Verified September 2016 by Jenny C. Chang, MD, The Methodist Hospital System
Sponsor:
ClinicalTrials.gov Identifier:
NCT02073487
First Posted: February 27, 2014
Last Update Posted: September 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Celgene Corporation
Novartis
The Methodist Hospital System
Information provided by (Responsible Party):
Jenny C. Chang, MD, The Methodist Hospital System
February 18, 2014
February 27, 2014
September 14, 2016
February 2014
June 2017   (Final data collection date for primary outcome measure)
pathological complete response rate (pCR) [ Time Frame: From date of randomization until the date of surgery, approximately 16 weeks ]
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.
Same as current
Complete list of historical versions of study NCT02073487 on ClinicalTrials.gov Archive Site
  • Clinical Response Rate [ Time Frame: From date of randomization until completion of neoadjuvant treatment, approximately 16 weeks ]
    To determine the clinical response rate in patients with palpable disease.
  • breast imaging response to treatment [ Time Frame: approximately 16 weeks ]
    To determine the imaging response to neoadjuvant therapy through breast imaging (mammogram, ultrasound and MRI) using RECIST.
  • objective response rate [ Time Frame: approximately 16 weeks ]
    To compare overall objective response rate in both treatment groups.
  • toxicity, safety and efficacy of study treatment [ Time Frame: approximately 16 weeks from randomization ]
    To assess toxicity, safety and efficacy of Trastuzumab Emtansine when combine with Lapatinib follow by Abraxane
Same as current
determine predictive markers [ Time Frame: approximately 1 year ]
To determine predictive markers for sensitivity and resistance to Trastuzumab Emtansine when combined with Lapatinib follow by Abraxane
Same as current
 
Neoadjuvant TDM1 With Lapatinib and Abraxane Compared With Trastuzumab Plus Pertuzumab With Paclitaxel
Randomized Open Label PhII Trial of Neoadjuvant Trastuzumab Emtansine (Te) in Combination w/Lapatinib (L) Followed by Abraxane (A) Compared w/Trastuzumab Plus Pertuzumab Followed by Paclitaxel in Her 2 Neu Over-Expressed Breast Cancer Patients

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 Pertuzumab follow by paclitaxel.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • Drug: Trastuzumab Emtansine
    trastuzumab emtansine [Kadcyla] Intravenous repeating dose every 3 weeks
    Other Names:
    • TDM1
    • Kadcyla
  • Drug: Trastuzumab
    Trastuzumab (Herceptin) Intravenous repeating dose weekly
    Other Name: Herceptin
  • Drug: Lapatinib
    Lapatinib repeating dose taken orally every day for 6 weeks
    Other Name: tykerb
  • Drug: Abraxane
    Abraxane repeating dose weekly IV for up to 12 weeks
  • Drug: Paclitaxel
    Paclitaxel IV repeating dose weekly for up to 12 weeks
  • Drug: Pertuzumab
    Pertuzumab repeating dose weekly IV for up to 12 weeks
    Other Name: Perjeta
  • Experimental: TDM1 with Laptinib followed by Abraxane
    Trastuzumab Emtansine IV every three weeks plus Lapatinib oral daily for a total of six (6) weeks followed by Abraxane IV weekly for twelve (12) weeks.
    Interventions:
    • Drug: Trastuzumab Emtansine
    • Drug: Lapatinib
    • Drug: Abraxane
  • Active Comparator: Herceptin plus Pertuzumab followed by paclitaxel
    Trastuzumab (Herceptin) IV weekly plus Pertuzumab IV for a total of six (6) weeks, followed by weekly IV paclitaxel for twelve (12) weeks.
    Interventions:
    • Drug: Trastuzumab
    • Drug: Paclitaxel
    • Drug: Pertuzumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
June 2017
June 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact: Houston Methodist Cancer Center 713-441-0629 ccresearch@houstonmethodist.org
United States
 
 
NCT02073487
1013-0164
No
Not Provided
Not Provided
Jenny C. Chang, MD, The Methodist Hospital System
Jenny C. Chang, MD
  • Celgene Corporation
  • Novartis
  • The Methodist Hospital System
Principal Investigator: Jenny C Chang, MD The Methodist Hospital System
The Methodist Hospital System
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP