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COMPLETEDPHASE2

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 Her2/Neu Over-Expressed Breast Cancer Patients

NCT02073487•The Methodist Hospital Research Institute

View on ClinicalTrials.gov

Summary

Detailed Description

This is a randomized, open label Phase II neoadjuvant study comparing the efficacy and safety of trastuzumab emtansine (T-DM1) plus lapatinib (L) followed by abraxane (A) versus trastuzumab plus pertuzumab followed by paclitaxel in patients with HER2-overexpressing breast cancer. Patients will be randomized (1:1) to one of the two treatment arms: arm 1, trastuzumab emtansine plus lapatinib for 6 weeks, followed by trastuzumab emtansine plus lapatinib plus abraxane for 12 weeks; arm 2, trastuzumab plus pertuzumab for six weeks, followed by trastuzumab plus pertuzumab plus paclitaxel for 12 weeks. Patients will undergo surgery after neoadjuvant therapy. All patients will have a core needle biopsy at baseline, after week 6, and at the time of disease progression. Surgical specimens will be obtained after week 18.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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:
+8 more criteria

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;
+7 more criteria

Locations (3)

Houston Methodist Hospital

Houston, Texas, United States

Houston Methodist Hospital Willowbrook

Houston, Texas, United States

Houston Methodist Hospital Sugar Land

Sugar Land, Texas, United States

Key Dates

Start Date

February 1, 2014

Primary Completion Date

January 1, 2019

Completion Date

January 1, 2019

Last Updated

September 22, 2021

Enrollment

ACTUAL participants

Conditions

Breast Cancer

Interventions

T-DM1

DRUG

Trastuzumab

DRUG

Lapatinib

DRUG

Abraxane

DRUG

Paclitaxel

DRUG

Pertuzumab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 22, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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